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CompletedNCT05741294Updated Feb 20, 2025Results posted

A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

A Phase 4 interventional study of Tirbanibulin 2.5 mg ointment in Actinic Keratosis, sponsored by Almirall, S.A.. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Almirall, S.A. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
334
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.

02

Conditions studied

  • Actinic Keratosis

Keywords

  • Keratosis
  • Tirbanibulin
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 334 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Almirall, S.A. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent.
  2. Males or females aged greater than or equal to (>=)18 years.
  3. Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25\^cm2 containing 4-8 AK lesions.
  4. Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25\^cm2) in the last greater than >1 to less than \<6 months is allowed.
  5. Females must be postmenopausal (A female said to be postmenopausal should be >45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse.
  6. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
  7. All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment.
  8. Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration.
  9. Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp.

Exclusion criteria

Exclusion Criteria:

  1. Clinically atypical and/or rapidly changing AK lesions.
  2. Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC).
  3. Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk.
  4. History of sensitivity to any of the ingredients in the tirbanibulin formulation.
  5. Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
  6. Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions.
  7. Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months.
  8. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.

  9. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:

    • Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
    • Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
    • Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area.
  10. Females who are pregnant or nursing.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
334 participants (actual)

Study arms

  • Experimental
    Tirbanibulin 2.5 milligrams (mg) ointment

    Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.

    Drug: Tirbanibulin 2.5 mg ointment

Interventions

  • DrugTirbanibulin 2.5 mg ointment

    Participants will apply tirbanibulin 2.5 mg ointment topically for 5 consecutive days over 25 square centimeters (cm\^2) of the face or scalp.

06

What researchers measure

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57

    TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.

    Time frame: At Day 57

Secondary outcomes

  1. Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57

    Skindex-16 was used for participants to rate skin conditions that have occurred within the previous week. The Skindex-16 consisted of 16 items that were divided into three sub-scores: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular quality of life assessment.

    Time frame: Baseline, Day 57

  2. Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8

    Likert scale was an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire was built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from "totally agree",' In agreement", "Somewhat agree", "Neither agree nor disagree", "Something in disagreement", "In disagreement" and "totally in disagreement".

    Time frame: At Day 8

  3. Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57

    TSQM 1.4 was a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.

    Time frame: At Day 57

  4. Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57

    An expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method. Expert panel agreed to ask 9 specific items; 1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on your daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: You need to be retreated for AK, how likely are you to consider tirbanibulin (very unlikely to very likely).

    Time frame: At Day 57

  5. Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57

    An expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method. Expert panel agreed to ask 10 specific items-1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on patient's daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely to very likely);10: severity of skin photodamage in the original AK treated area (absent to severe).

    Time frame: At Day 57

  6. Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57

    Complete clearance of all AK lesions within the application area, is defined as a reduction from baseline in the number of lesions = 100% at Day 57. Percentage of participants with complete clearance with a reduction of 100% (i.e., clearance percentage = 100% from Baseline) in the number of lesions within the application area were reported.

    Time frame: At Day 57

  7. Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57

    Participants with partial clearance were patients with a reduction of \>=75% (i.e., clearance percentage \<=-75% from Baseline) to \<100% in the number of lesions within the application area at final visit.

    Time frame: At Day 57

  8. Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57

    Percent change from baseline in number of old and new AK lesions at Day 57 was reported. Number of lesions at Day 57 was calculated considering both old and new lesions, as: N lesions at Baseline - N lesions at Day 57/ N lesions at Baseline \* 100%.

    Time frame: At Day 57

  9. Percentage of Participants by Olsen Characterization at Baseline and Day 57

    The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II: describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III: denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).

    Time frame: Baseline (Day 0) and Day 57

  10. Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint

    LC-OCT was a novel non-invasive imaging technique that enables in vivo visualization of the skin. It has been used for diagnosing and monitoring the treatment of skin disorders, including actinic keratosis. The use of LC-OCT in AK treatment progression allows for lesion classification based on histological features without the need for a biopsy. The histopathology of the skin was evaluated based on the estimated atypia score at cellular level of the LC-OCT images of clinical and subclinical lesions. Percentage of participants who performed LC-OCT for clinical and subclinical lesions assessment at each timepoint were reported.

    Time frame: Baseline, Day 8, Day 15, Day 29, and Day 57

  11. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs

    An adverse event (AE) is as any untoward medical occurrence associated with the use of an intervention in humans after providing written informed consent for participation in the study until the end of study visit, whether considered intervention-related or not. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Severity of TEAEs is graded as follows: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.

    Time frame: From start of study administration up to Day 57

07

Results

Posted Feb 20, 2025

Participant flow

This study was conducted at 37 sites in Europe (7 in Italy and 30 in Spain) from 20 January 2023 to 19 January 2024.

Participant flow — Overall Study
MilestoneTirbanibulin 2.5 mg
Started334
Evaluable population328
Line-field confocal optical coherence tomography (lc-oct) population12
Safety population334
Completed327
Not completed7
Withdrew: Lost to follow-up3
Withdrew: Protocol deviation3
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryTreatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57

TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.

Time frame:
At Day 57
Reported as:
Mean · score on a scale
Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57
score on a scaleTirbanibulin 2.5 mg
Effectiveness Total Score Value73.64 (71.28 to 76.01)
Convenience Total Score Value82.81 (81.28 to 84.34)
Global Satisfaction Total Score Value76.94 (74.89 to 78.99)
SecondaryChange From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57

Skindex-16 was used for participants to rate skin conditions that have occurred within the previous week. The Skindex-16 consisted of 16 items that were divided into three sub-scores: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular quality of life assessment.

Time frame:
Baseline, Day 57
Reported as:
Mean · score on a scale
Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57
score on a scaleTirbanibulin 2.5 mg
Symptoms Sub-Score: Change at Day 57-10.49 (-12.55 to -8.44)
Emotions Sub-Score: Change at Day 57-11.56 (-13.56 to -9.55)
Functioning Sub-Score: Change at Day 57-2.49 (-3.98 to -1.00)
SecondaryPercentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8

Likert scale was an instrument used to measure the individual's degree of agreement and disagreement with a variety of statements about some attitude, options, or their feelings. In this study, the product's organoleptic properties are evaluated with Likert scale. The questionnaire was built with questions related to the product's characteristics namely appearance, color, convenience, texture, smell, and the feelings experienced during drug application. The Likert scale offers 7 possible answers, from "totally agree",' In agreement", "Somewhat agree", "Neither agree nor disagree", "Something in disagreement", "In disagreement" and "totally in disagreement".

Time frame:
At Day 8
Reported as:
Number · Percentage of participants
Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8
Percentage of participantsTirbanibulin 2.5 mg
The general appearance of the product is good: Totally agree52.60 (43.75 to 61.34)
The general appearance of the product is good: In agreement38.23 (29.91 to 47.04)
The general appearance of the product is good: Somewhat agree3.06 (0.85 to 7.22)
The general appearance of the product is good: Neither agree nor disagree5.20 (2.11 to 10.15)
The general appearance of the product is good: Something in disagreement0.31 (0.00 to 2.76)
The general appearance of the product is good: In disagreement0.61 (0.00 to 3.36)
The general appearance of the product is good: Totally in disagreement0 (0 to 0)
The overall assessment of the product is very satisfactory: Totally agree36.70 (27.64 to 46.33)
The overall assessment of the product is very satisfactory: In agreement38.53 (29.35 to 48.21)
The overall assessment of the product is very satisfactory: Somewhat agree8.26 (3.75 to 14.57)
The overall assessment of the product is very satisfactory: Neither agree nor disagree10.40 (5.28 to 17.23)
The overall assessment of the product is very satisfactory: Something in disagreement1.53 (0.00 to 5.18)
The overall assessment of the product is very satisfactory: In disagreement3.36 (0.74 to 8.01)
The overall assessment of the product is very satisfactory: Totally in disagreement1.22 (0.00 to 4.66)
I would recommend the product: Totally agree34.86 (25.95 to 44.43)
I would recommend the product: In agreement33.64 (24.83 to 43.15)
I would recommend the product: Somewhat agree5.81 (2.13 to 11.40)
I would recommend the product: Neither agree nor disagree18.04 (11.25 to 26.22)
I would recommend the product: Something in disagreement1.22 (0.00 to 4.66)
I would recommend the product: In disagreement3.06 (0.59 to 7.56)
I would recommend the product: Totally in disagreement3.36 (0.74 to 8.01)
The color of the product is nice: Totally agree36.70 (29.37 to 44.55)
The color of the product is nice: In agreement36.09 (28.80 to 43.92)
The color of the product is nice: Somewhat agree5.81 (2.90 to 10.47)
The color of the product is nice: Neither agree nor disagree20.80 (14.96 to 27.79)
The color of the product is nice: Something in disagreement0 (0 to 0)
The color of the product is nice: In disagreement0.61 (0.02 to 3.17)
The color of the product is nice: Totally in disagreement0 (0 to 0)
The texture of the product is nice: Totally agree48.93 (40.14 to 57.76)
The texture of the product is nice: In agreement40.37 (31.92 to 49.21)
The texture of the product is nice: Somewhat agree5.20 (2.11 to 10.15)
The texture of the product is nice: Neither agree nor disagree4.28 (1.54 to 8.93)
The texture of the product is nice: Something in disagreement0.61 (0.00 to 3.36)
The texture of the product is nice: In disagreement0.61 (0.00 to 3.36)
The texture of the product is nice: Totally in disagreement0 (0 to 0)
The texture of the product is watery: Totally agree12.84 (7.12 to 20.18)
The texture of the product is watery: In agreement18.65 (11.76 to 26.91)
The texture of the product is watery: Somewhat agree9.79 (4.83 to 16.48)
The texture of the product is watery: Neither agree nor disagree15.90 (9.52 to 23.76)
The texture of the product is watery: Something in disagreement8.26 (3.75 to 14.57)
The texture of the product is watery: In disagreement19.88 (12.77 to 28.29)
The texture of the product is watery: Totally in disagreement14.68 (8.54 to 22.34)
The texture of the product is oily: Totally agree11.31 (5.96 to 18.35)
The texture of the product is oily: In agreement15.90 (9.52 to 23.76)
The texture of the product is oily: Somewhat agree9.48 (4.61 to 16.10)
The texture of the product is oily: Neither agree nor disagree16.82 (10.26 to 24.82)
The texture of the product is oily: Something in disagreement6.73 (2.72 to 12.61)
The texture of the product is oily: In disagreement20.49 (13.28 to 28.97)
The texture of the product is oily: Totally in disagreement19.27 (12.26 to 27.60)
The texture of the product is creamy: Totally agree40.06 (30.78 to 49.77)
The texture of the product is creamy: In agreement41.28 (31.93 to 51.01)
The texture of the product is creamy: Somewhat agree7.03 (2.92 to 13.00)
The texture of the product is creamy: Neither agree nor disagree7.34 (3.13 to 13.40)
The texture of the product is creamy: Something in disagreement1.53 (0.00 to 5.18)
The texture of the product is creamy: In disagreement1.83 (0.08 to 5.68)
The texture of the product is creamy: Totally in disagreement0.92 (0.00 to 4.11)
The skin was greasy after applying the treatment: Totally agree12.84 (7.12 to 20.18)
The skin was greasy after applying the treatment: In agreement25.08 (17.20 to 34.03)
The skin was greasy after applying the treatment: Somewhat agree14.68 (8.54 to 22.34)
The skin was greasy after applying the treatment: Neither agree nor disagree8.56 (3.96 to 14.95)
The skin was greasy after applying the treatment: Something in disagreement3.98 (1.06 to 8.89)
The skin was greasy after applying the treatment: In disagreement17.13 (10.50 to 25.17)
The skin was greasy after applying the treatment: Totally in disagreement17.74 (11.00 to 25.87)
The smell of the product is pleasant: Totally agree23.85 (16.14 to 32.70)
The smell of the product is pleasant: In agreement23.55 (15.88 to 32.36)
The smell of the product is pleasant: Somewhat agree7.65 (3.33 to 13.79)
The smell of the product is pleasant: Neither agree nor disagree42.51 (33.09 to 52.25)
The smell of the product is pleasant: Something in disagreement0.61 (0.00 to 3.53)
The smell of the product is pleasant: In disagreement0.92 (0.00 to 4.11)
The smell of the product is pleasant: Totally in disagreement0.92 (0.00 to 4.11)
The product feels pleasant on the skin: Totally agree27.22 (19.07 to 36.35)
The product feels pleasant on the skin: In agreement30.28 (21.79 to 39.61)
The product feels pleasant on the skin: Somewhat agree10.70 (5.50 to 17.60)
The product feels pleasant on the skin: Neither agree nor disagree21.10 (13.80 to 29.66)
The product feels pleasant on the skin: Something in disagreement1.83 (0.08 to 5.68)
The product feels pleasant on the skin: In disagreement5.50 (1.95 to 10.99)
The product feels pleasant on the skin: Totally in disagreement3.36 (0.74 to 8.01)
The feel of the product on the skin is refreshing: Totally agree18.35 (11.50 to 26.56)
The feel of the product on the skin is refreshing: In agreement20.80 (13.54 to 29.32)
The feel of the product on the skin is refreshing: Somewhat agree11.31 (5.96 to 18.35)
The feel of the product on the skin is refreshing: Neither agree nor disagree22.94 (15.36 to 31.69)
The feel of the product on the skin is refreshing: Something in disagreement5.81 (2.13 to 11.40)
The feel of the product on the skin is refreshing: In disagreement10.09 (5.06 to 16.86)
The feel of the product on the skin is refreshing: Totally in disagreement10.70 (5.50 to 17.60)
The product offers a protective feeling: Totally agree20.80 (13.54 to 29.32)
The product offers a protective feeling: In agreement25.38 (17.47 to 34.36)
The product offers a protective feeling: Somewhat agree9.48 (4.61 to 16.10)
The product offers a protective feeling: Neither agree nor disagree30.28 (21.79 to 39.61)
The product offers a protective feeling: Something in disagreement3.06 (0.59 to 7.56)
The product offers a protective feeling: In disagreement5.81 (2.13 to 11.40)
The product offers a protective feeling: Totally in disagreement5.20 (1.76 to 10.58)
The product is easy to apply: Totally agree66.36 (56.85 to 75.17)
The product is easy to apply: In agreement27.22 (19.07 to 36.35)
The product is easy to apply: Somewhat agree3.67 (0.89 to 8.45)
The product is easy to apply: Neither agree nor disagree0.92 (0.00 to 4.11)
The product is easy to apply: Something in disagreement0.92 (0.00 to 4.11)
The product is easy to apply: In disagreement0.31 (0.00 to 2.90)
The product is easy to apply: Totally in disagreement0.61 (0.00 to 3.53)
The product can be distributed evenly and easily: Totally agree64.53 (55.79 to 72.66)
The product can be distributed evenly and easily: In agreement29.05 (21.48 to 37.50)
The product can be distributed evenly and easily: Somewhat agree4.28 (1.54 to 8.93)
The product can be distributed evenly and easily: Neither agree nor disagree0.61 (0.00 to 3.36)
The product can be distributed evenly and easily: Something in disagreement0.92 (0.00 to 3.91)
The product can be distributed evenly and easily: In disagreement0.61 (0.00 to 3.36)
The product can be distributed evenly and easily: Totally in disagreement0 (0 to 0)
Product remains on application area, without spreading to neighboring areas: Totally agree57.19 (47.44 to 66.62)
Product remains on application area, without spreading to neighboring areas: In agreement29.97 (21.52 to 39.29)
Product remains on application area, without spreading to neighboring areas: Somewhat agree6.12 (2.33 to 11.81)
Product remains on application area, without spreading to neighboring areas: Neither agree/ disagree2.75 (0.44 to 7.11)
Product remains on application area without spreading to neighboring areas:Something in disagreement2.14 (0.19 to 6.17)
Product remains on application area, without spreading to neighboring areas: In disagreement0.61 (0.00 to 3.53)
Product remains on application area, without spreading to neighboring areas: Totally in disagreement1.22 (0.00 to 4.66)
The product packaging is practical: Totally agree50.76 (41.06 to 60.43)
The product packaging is practical: In agreement33.94 (25.11 to 43.47)
The product packaging is practical: Somewhat agree6.12 (2.33 to 11.81)
The product packaging is practical: Neither agree nor disagree3.06 (0.59 to 7.56)
The product packaging is practical: Something in disagreement2.14 (0.19 to 6.17)
The product packaging is practical: In disagreement3.36 (0.74 to 8.01)
The product packaging is practical: Totally in disagreement0.61 (0.00 to 3.53)
SecondaryTreatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57

TSQM 1.4 was a 14-item robust instrument that psychometrically evaluates the treatment satisfaction of the administered medication. The instrument is designed with 4 scales consisting of 14 questions. These 14 questions were derived from an original set of 55 questions extracted from exhaustive literature review and treatment groups through multistep iterative process. The 4 scales focused on effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.

Time frame:
At Day 57
Reported as:
Mean · score on a scale
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57
score on a scaleTirbanibulin 2.5 mg
Effectiveness score value at Day 5773.64 (71.28 to 76.01)
Convenience score value at Day 5782.81 (81.28 to 84.34)
Side Effects score value at Day 5797.47 (96.59 to 98.34)
Global satisfaction score value at Day 5776.94 (74.89 to 78.99)
SecondaryPercentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57

An expert panel on consensus developed a questionnaire directed to patients consisting of 9 simple items using a qualitative modified delphi method. Expert panel agreed to ask 9 specific items; 1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on your daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: You need to be retreated for AK, how likely are you to consider tirbanibulin (very unlikely to very likely).

Time frame:
At Day 57
Reported as:
Number · Percentage of patients
Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57
Percentage of patientsTirbanibulin 2.5 mg
Overall appearance of the skin: Much worse0.31 (0.00 to 2.68)
Overall appearance of the skin: Somewhat worse0.31 (0.00 to 2.68)
Overall appearance of the skin: No change6.92 (3.66 to 11.94)
Overall appearance of the skin: Somewhat improved24.84 (18.45 to 32.27)
Overall appearance of the skin: Much improved67.61 (59.78 to 74.72)
Treatment satisfaction of skin looks: Extremely Dissatisfied0 (0 to 0)
Treatment satisfaction of skin looks: Very Dissatisfied0.63 (0.00 to 3.45)
Treatment satisfaction of skin looks: Dissatisfied2.83 (0.71 to 6.97)
Treatment satisfaction of skin looks: Somewhat Satisfied7.23 (3.43 to 12.86)
Treatment satisfaction of skin looks: Satisfied25.79 (18.47 to 34.14)
Treatment satisfaction of skin looks: Very Satisfied30.19 (22.40 to 38.82)
Treatment satisfaction of skin looks: Extremely Satisfied33.33 (25.26 to 42.12)
Treatment satisfaction of skin texture: Extremely Dissatisfied0 (0 to 0)
Treatment satisfaction of skin texture: Very Dissatisfied1.25 (0.05 to 4.51)
Treatment satisfaction of skin texture: Dissatisfied2.80 (0.70 to 6.91)
Treatment satisfaction of skin texture: Somewhat Satisfied7.17 (3.40 to 12.75)
Treatment satisfaction of skin texture: Satisfied30.84 (23.03 to 39.47)
Treatment satisfaction of skin texture: Very Satisfied27.73 (20.23 to 36.17)
Treatment satisfaction of skin texture: Extremely Satisfied30.22 (22.46 to 38.81)
Duration of skin reactions: Much shorter44.62 (34.53 to 55.09)
Duration of skin reactions: Somewhat shorter23.66 (15.73 to 33.40)
Duration of skin reactions: Same18.82 (11.74 to 28.04)
Duration of skin reactions: Somewhat longer9.14 (4.42 to 16.67)
Duration of skin reactions: Much longer3.76 (1.11 to 9.60)
Rate the severity of skin reactions: Much better51.34 (40.98 to 61.60)
Rate the severity of skin reactions: Somewhat better21.93 (14.30 to 31.47)
Rate the severity of skin reactions: Same16.58 (9.97 to 25.48)
Rate the severity of skin reactions: Somewhat worse8.02 (3.68 to 15.24)
Rate the severity of skin reactions: Much worse2.14 (0.37 to 7.18)
Impact on your daily activities due to skin reactions: Much better49.74 (39.48 to 60.00)
Impact on your daily activities due to skin reactions: Somewhat better13.76 (7.81 to 22.16)
Impact on your daily activities due to skin reactions: Same31.75 (22.79 to 41.94)
Impact on your daily activities due to skin reactions: Somewhat worse3.70 (1.09 to 9.46)
Impact on your daily activities due to skin reactions: Much worse1.06 (0.04 to 5.39)
Rate the convenience/ease of use: Much better57.97 (48.02 to 67.42)
Rate the convenience/ease of use: Somewhat better19.81 (12.86 to 28.63)
Rate the convenience/ease of use: Same19.81 (12.86 to 28.63)
Rate the convenience/ease of use: Somewhat worse1.93 (0.34 to 6.51)
Rate the convenience/ease of use: Much worse0.48 (0.00 to 4.08)
Rate your overall satisfaction: Much better60.29 (50.40 to 69.54)
Rate your overall satisfaction: Somewhat better21.53 (14.32 to 30.49)
Rate your overall satisfaction: Same13.40 (7.77 to 21.28)
Rate your overall satisfaction: Somewhat worse3.83 (1.24 to 9.26)
Rate your overall satisfaction: Much worse0.96 (0.04 to 4.89)
You need to be retreated for AK, how likely to consider tirbanibulin: Very unlikely3.66 (1.49 to 7.67)
You need to be retreated for AK, how likely to consider tirbanibulin: Somewhat unlikely2.44 (0.78 to 5.98)
You need to be retreated for AK, how likely to consider tirbanibulin: Neutral7.62 (4.21 to 12.72)
You need to be retreated for AK, how likely to consider tirbanibulin: Somewhat likely18.60 (13.08 to 25.37)
You need to be retreated for AK, how likely to consider tirbanibulin: Very likely67.68 (59.98 to 74.69)
SecondaryPercentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57

An expert panel on consensus developed a questionnaire directed to physicians consisting of 10 simple items using a qualitative modified delphi method. Expert panel agreed to ask 10 specific items-1: Overall appearance of the skin (much worse to much improved); 2: Treatment satisfaction of skin looks (extremely dissatisfied to extremely satisfied); 3: Treatment satisfaction of skin texture (extremely dissatisfied to extremely satisfied); 4: Duration of skin reactions (much shorter to much longer); 5: rate the severity of skin reactions (much better to much worse); 6: impact on patient's daily activities due to skin reactions (much better to much worse); 7: rate the convenience/ease of use (much better to much worse); 8: rate your overall satisfaction (much better to much worse); 9: patient needs to be retreated for AK, how likely to consider tirbanibulin (very unlikely to very likely);10: severity of skin photodamage in the original AK treated area (absent to severe).

Time frame:
At Day 57
Reported as:
Number · Percentage of physician
Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57
Percentage of physicianTirbanibulin 2.5 mg
Overall appearance of the skin:Much worse1.23 (0.21 to 4.19)
Overall appearance of the skin: Somewhat worse1.23 (0.21 to 4.19)
Overall appearance of the skin: No change1.23 (0.21 to 4.19)
Overall appearance of the skin: Somewhat improved21.78 (15.81 to 28.87)
Overall appearance of the skin: Much improved74.54 (67.17 to 80.93)
Treatment satisfaction of skin looks: Extremely Dissatisfied0.31 (0.00 to 2.93)
Treatment satisfaction of skin looks: Very Dissatisfied0.31 (0.00 to 2.93)
Treatment satisfaction of skin looks: Dissatisfied0.31 (0.00 to 2.93)
Treatment satisfaction of skin looks: Somewhat Satisfied6.79 (2.75 to 12.72)
Treatment satisfaction of skin looks: Satisfied25.31 (17.37 to 34.33)
Treatment satisfaction of skin looks: Very Satisfied31.48 (22.84 to 40.93)
Treatment satisfaction of skin looks: Extremely Satisfied35.49 (26.49 to 45.13)
Treatment satisfaction of skin texture: Extremely Dissatisfied0.31 (0.00 to 2.92)
Treatment satisfaction of skin texture: Very Dissatisfied0.31 (0.00 to 2.92)
Treatment satisfaction of skin texture: Dissatisfied0.92 (0.00 to 4.14)
Treatment satisfaction of skin texture: Somewhat Satisfied6.77 (2.74 to 12.68)
Treatment satisfaction of skin texture: Satisfied27.69 (19.47 to 36.89)
Treatment satisfaction of skin texture: Very Satisfied32.92 (24.16 to 42.43)
Treatment satisfaction of skin texture: Extremely Satisfied31.08 (22.49 to 40.49)
Duration of skin reactions: Much shorter60.09 (50.51 to 69.08)
Duration of skin reactions: Somewhat shorter27.35 (19.54 to 36.48)
Duration of skin reactions: Same8.52 (4.29 to 15.14)
Duration of skin reactions: Somewhat longer3.14 (0.92 to 8.06)
Duration of skin reactions: Much longer0.90 (0.03 to 4.60)
Rate the severity of skin reactions: Much better64.86 (55.36 to 73.15)
Rate the severity of skin reactions: Somewhat better22.07 (14.96 to 30.80)
Rate the severity of skin reactions: Same9.01 (4.63 to 15.76)
Rate the severity of skin reactions: Somewhat worse3.60 (1.16 to 8.74)
Rate the severity of skin reactions: Much worse0.45 (0.00 to 3.81)
Impact on patient's daily activities due to skin reactions: Much better59.81 (50.04 to 69.00)
Impact on patient's daily activities due to skin reactions: Somewhat better19.63 (12.81 to 28.27)
Impact on patient's daily activities due to skin reactions: Same19.63 (12.81 to 28.27)
Impact on patient's daily activities due to skin reactions: Somewhat worse0.47 (0.00 to 3.95)
Impact on patient's daily activities due to skin reactions: Much worse0.47 (0.00 to 3.95)
Rate the convenience/ease of use: Much better65.78 (57.55 to 73.16)
Rate the convenience/ease of use: Somewhat better25.33 (18.82 to 33.17)
Rate the convenience/ease of use: Same5.33 (2.66 to 10.42)
Rate the convenience/ease of use: Somewhat worse3.56 (1.52 to 8.10)
Rate the convenience/ease of use: Much worse0 (0 to 0)
Rate your overall satisfaction: Much better50.66 (41.25 to 60.03)
Rate your overall satisfaction: Somewhat better37.00 (28.30 to 46.45)
Rate your overall satisfaction: Same11.01 (6.14 to 18.11)
Rate your overall satisfaction: Somewhat worse0.88 (0.03 to 4.52)
Rate your overall satisfaction: Much worse0.44 (0.00 to 3.73)
Patient needs to be retreated for AK, how likely to consider tirbanibulin: Very unlikely3.68 (1.50 to 7.71)
Patient needs to be retreated for AK, how likely to consider tirbanibulin: Somewhat unlikely1.53 (0.34 to 4.66)
Patient needs to be retreated for AK, how likely to consider tirbanibulin: Neutral7.67 (4.24 to 12.79)
Patient needs to be retreated for AK, how likely to consider tirbanibulin: Somewhat likely23.01 (16.89 to 30.20)
Patient needs to be retreated for AK, how likely to consider tirbanibulin: Very likely64.11 (56.26 to 71.39)
Severity of skin photodamage in the original AK treated area: Absent24.85 (19.38 to 31.26)
Severity of skin photodamage in the original AK treated area: Mild46.63 (39.85 to 53.53)
Severity of skin photodamage in the original AK treated area: Moderate27.61 (21.89 to 34.17)
Severity of skin photodamage in the original AK treated area: Severe0.92 (0.24 to 3.44)
SecondaryPercentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57

Complete clearance of all AK lesions within the application area, is defined as a reduction from baseline in the number of lesions = 100% at Day 57. Percentage of participants with complete clearance with a reduction of 100% (i.e., clearance percentage = 100% from Baseline) in the number of lesions within the application area were reported.

Time frame:
At Day 57
Reported as:
Number · Percentage of participants
Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57
Percentage of participantsTirbanibulin 2.5 mg
Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 5754.27 (48.71 to 59.75)
SecondaryPercentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57

Participants with partial clearance were patients with a reduction of \>=75% (i.e., clearance percentage \<=-75% from Baseline) to \<100% in the number of lesions within the application area at final visit.

Time frame:
At Day 57
Reported as:
Number · Percentage of participants
Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57
Percentage of participantsTirbanibulin 2.5 mg
Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 5722.56 (18.15 to 27.47)
SecondaryPercent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57

Percent change from baseline in number of old and new AK lesions at Day 57 was reported. Number of lesions at Day 57 was calculated considering both old and new lesions, as: N lesions at Baseline - N lesions at Day 57/ N lesions at Baseline \* 100%.

Time frame:
At Day 57
Reported as:
Mean · Percent change
Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57
Percent changeTirbanibulin 2.5 mg
Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57-82.22 ± 26.367
SecondaryPercentage of Participants by Olsen Characterization at Baseline and Day 57

The lesions in the identified treatment area will be classified based on Olsen characterization. Classification of AK lesions according to Olsen grade of baseline lesions: Olsen Grade I: Early AK appear as single or few, differently sized, rough, blurred, less visible than palpable, red, rough spots or very flat, non-edged plaques which reach into the reddish color; Olsen grade II: describes advanced AK as clearly visible and palpable, flat, and irregularly raised, with sharp or blurred boundaries, red, rough keratinized surface. If the surface is more strongly keratinized, the AK can also be white, yellow, or light brown. After scratching effects, a black or blue-black shade may appear; Olsen grade III: denotes "late" AK that have existed for a longer period of time and are firmly anchored on the lower surface, with an irregular, humpy surface, also wart-like and of different colors (white, brown, black).

Time frame:
Baseline (Day 0) and Day 57
Reported as:
Number · Percentage of participants
Percentage of Participants by Olsen Characterization at Baseline and Day 57
Percentage of participantsTirbanibulin 2.5 mg
Olsen Grade I: Baseline62.80 (54.95 to 70.15)
Olsen Grade I: Day 5739.33 (30.95 to 48.15)
Olsen Grade II: Baseline8.84 (5.12 to 14.19)
Olsen Grade II: Day 573.66 (1.18 to 8.06)
Olsen Grade III: Baseline0.0 (0.00 to 0.00)
Olsen Grade III: Day 570.30 (0.00 to 2.75)
SecondaryPercentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint

LC-OCT was a novel non-invasive imaging technique that enables in vivo visualization of the skin. It has been used for diagnosing and monitoring the treatment of skin disorders, including actinic keratosis. The use of LC-OCT in AK treatment progression allows for lesion classification based on histological features without the need for a biopsy. The histopathology of the skin was evaluated based on the estimated atypia score at cellular level of the LC-OCT images of clinical and subclinical lesions. Percentage of participants who performed LC-OCT for clinical and subclinical lesions assessment at each timepoint were reported.

Time frame:
Baseline, Day 8, Day 15, Day 29, and Day 57
Reported as:
Number · Percentage of participants
Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint
Percentage of participantsTirbanibulin 2.5 mg
At Baseline100.00
At Day 891.67
At Day 1591.67
At Day 2991.67
At Day 57100.00
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs

An adverse event (AE) is as any untoward medical occurrence associated with the use of an intervention in humans after providing written informed consent for participation in the study until the end of study visit, whether considered intervention-related or not. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Severity of TEAEs is graded as follows: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.

Time frame:
From start of study administration up to Day 57
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs
ParticipantsTirbanibulin 2.5 mg
Participants with TEAEs153
Severity of TEAEs: Grade 1132
Severity of TEAEs: Grade 217
Severity of TEAEs: Grade 33
Severity of TEAEs: Grade 41

Adverse events

Collected over From start of study administration up to Day 57. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tirbanibulin 2.5 mg0/334 (0%)0/334 (0%)153/334 (45.8%)
Most frequent other events
Showing 10 of 46
Most frequent other events
EventTirbanibulin 2.5 mg
PruritusSkin and subcutaneous tissue disorders92/334
PainGeneral disorders31/334
Burning sensationGeneral disorders17/334
HeadacheNervous system disorders13/334
FatigueGeneral disorders6/334
HypersensitivityImmune system disorders6/334
BlisterSkin and subcutaneous tissue disorders5/334
Thermal burnSkin and subcutaneous tissue disorders4/334
Application site painGeneral disorders3/334
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/334

Baseline characteristics

Full analysis set (FAS) population included all participants who signed the informed consent form and applied at least one dose of tirbanibulin.

Age, Continuous
Age, Continuous(years)Tirbanibulin 2.5 mg
Mean74.9 ± 8.51
Sex: Female, Male
Sex: Female, Male(Participants)Tirbanibulin 2.5 mg
Female56
Male278
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tirbanibulin 2.5 mg
Race: Caucasian334
08

Study locations

37 sites
  • Almirall Investigational Site 1
    Cagliari, Italy
  • Almirall Investigational Site 2
    Catania, Italy
  • Almirall Investigational Site 3
    Napoli, Italy
  • Almirall Investigational Site 4
    Pisa, Italy
  • Almirall Investigational Site 5
    Rimini, Italy
  • Almirall Investigational Site 6
    Torino, Italy
  • Almirall Investigational Site 7
    Trieste, Italy
  • Almirall Investigational Site 1
    Alcorcón, Spain
  • Almirall Investigational Site 2
    Alicante, Spain
  • Almirall Investigational Site 3
    Badalona, Spain
  • Almirall Investigational Site 4
    Barcelona, Spain
  • Almirall Investigational Site 5
    Barcelona, Spain
  • Almirall Investigational Site 6
    Barcelona, Spain
  • Almirall Investigational Site 7
    Barcelona, Spain
  • Almirall Investigational Site 8
    Bilbao, Spain
  • Almirall Investigational Site 9
    Córdoba, Spain
  • Almirall Investigational Site 10
    Fuenlabrada, Spain
  • Almirall Investigational Site 11
    Granada, Spain
  • Almirall Investigational Site 12
    Madrid, Spain
  • Almirall Investigational Site 13
    Madrid, Spain
  • Almirall Investigational Site 14
    Madrid, Spain
  • Almirall Investigational Site 15
    Madrid, Spain
  • Almirall Investigational Site 16
    Majadahonda, Spain
  • Almirall Investigational Site 17
    Málaga, Spain
  • Almirall Investigational Site 18
    Palma, Spain
  • Almirall Investigational Site 19
    Pontevedra, Spain
  • Almirall Investigational Site 20
    Sabadell, Spain
  • Almirall Investigational Site 21
    Salamanca, Spain
  • Almirall Investigational Site 22
    Santa Cruz de Tenerife, Spain
  • Almirall Investigational Site 23
    Sevilla, Spain
  • Almirall Investigational Site 24
    Sevilla, Spain
  • Almirall Investigational Site 25
    Valencia, Spain
  • Almirall Investigational Site 26
    Valencia, Spain
  • Almirall Investigational Site 27
    Valencia, Spain
  • Almirall Investigational Site 28
    Vigo, Spain
  • Almirall Investigational Site 29
    Zaragoza, Spain
  • Almirall Investigational Site 30
    Zaragoza, Spain
09

References and documents

Study documents

  • Study protocol · Aug 5, 2022
  • Statistical analysis plan · Feb 13, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05741294
Lead sponsor
Almirall, S.A.
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Jan 20, 2023
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024
Results posted
Feb 20, 2025
Last update
Feb 20, 2025

Study contacts

Alberto Lecchi
study director · Almirall, srl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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