A Phase 3 interventional study of KX2-391 Ointment 1% and Placebo in Actinic Keratosis, sponsored by Almirall, S.A.. Completed at 30 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Almirall, S.A. · Phase 3, Interventional, and Treatment
Among 14 studies in Keratosis, Actinic by Almirall, S.A. — none open to participants now, 1 under way, none of them phase 3. Keratosis, Actinic · Almirall, S.A..
Among the 14 studies in Keratosis, Actinic by Almirall, S.A., this one is the 4th largest by enrollment of the 12 interventional ones, is one of 2 that started in 2017, is one of 7 in phase 3, and was the 7th registered.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
This study's enrollment of 351 is above the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →None of the 14 studies in Keratosis, Actinic by Almirall, S.A. is open now.
Of the 21 Keratosis, Actinic studies recruiting now, 16 (76%) set no upper age limit and 1 (5%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2017.
Median enrollment 307 across the 12 interventional studies, 155 across the 2 observational. Of the 13 that completed or were terminated, 7 (54%) have results posted.
Almirall, S.A. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
1 of the studies in Keratosis, Actinic by Almirall, S.A. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05387525Almirall, S.A.A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp | 2027-07 |
Among the 14 studies in Keratosis, Actinic by Almirall, S.A., from their registry updates:
Nothing recorded among them since 2026-09-25.
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.
This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.
The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Location of the selected area is:
Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp.
Drug: KX2-391 Ointment 1%
The Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp.
Drug: Placebo
Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical
Dosage form: Ointment; Route of administration: Topical
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Time frame: Day 57
Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (\>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.
Time frame: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
Time frame: Days 8, 15, 29 and 57
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified.
Time frame: 3, 6, 9 and 12 months post-Day 57
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).
Time frame: Day 57
Number of Participants With Pigmentation and Scarring in the Treatment Area
Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Time frame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Time frame: Baseline (Day 1 predose) up to Day 57
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Time frame: From Day 57 up to 12-months post-Day 57
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Physical Examination
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Time frame: From Baseline (Day 1 predose) up to Day 57
The study was conducted at 31 sites in the United States between 15-September-2017 to 24-April-2019.
| Milestone | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Started | 173 | 178 |
| Completed | 173 | 178 |
| Not completed | 0 | 0 |
| Milestone | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Started | 22 | 97 |
| Completed | 4 | 36 |
| Not completed | 18 | 61 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Ak recurrence during recurrence follow-up period | 18 | 60 |
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
| percentage of participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | 13 | 54 |
Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (\>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.
| percentage of participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | 20 | 76 |
Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
| lesion count | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Day 8 | 0.0 (-8 to 1) | -1.0 (-7 to 3) |
| Day 15 | -1.0 (-7 to 1) | -4.0 (-8 to 3) |
| Day 29 | -1.0 (-7 to 2) | -5.0 (-8 to 1) |
| Day 57 | -1.0 (-8 to 2) | -5.0 (-8 to 1) |
Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified.
| percentage of participants | KX2-391 Ointment 1% |
|---|---|
| 3 months post-Day 57 | 27 |
| 6 months post-Day 57 | 31 |
| 9 months post-Day 57 | 27 |
| 12 months post-Day 57 | 23 |
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Erythema-Grade 0 | 79 | 3 |
| Erythema-Grade 1 | 81 | 47 |
| Erythema-Grade 2 | 13 | 111 |
| Erythema-Grade 3 | 0 | 17 |
| Flaking/Scaling-Grade 0 | 82 | 8 |
| Flaking/Scaling-Grade 1 | 69 | 60 |
| Flaking/Scaling-Grade 2 | 21 | 90 |
| Flaking/Scaling-Grade 3 | 1 | 20 |
| Crusting-Grade 0 | 148 | 92 |
| Crusting-Grade 1 | 19 | 51 |
| Crusting-Grade 2 | 6 | 30 |
| Crusting-Grade 3 | 0 | 5 |
| Swelling-Grade 0 | 169 | 110 |
| Swelling-Grade 1 | 4 | 47 |
| Swelling-Grade 2 | 0 | 20 |
| Swelling-Grade 3 | 0 | 1 |
| Vesiculation/Pustulation-Grade 0 | 172 | 166 |
| Vesiculation/Pustulation-Grade 1 | 1 | 11 |
| Vesiculation/Pustulation-Grade 2 | 0 | 0 |
| Vesiculation/Pustulation-Grade 3 | 0 | 1 |
| Erosion/Ulceration-Grade 0 | 171 | 156 |
| Erosion/Ulceration-Grade 1 | 2 | 18 |
| Erosion/Ulceration-Grade 2 | 0 | 4 |
| Erosion/Ulceration-Grade 3 | 0 | 0 |
Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Hypopigmentation: Baseline | 26 | 30 |
| Hypopigmentation: Day 5 | 26 | 28 |
| Hypopigmentation: Day 8 | 23 | 30 |
| Hypopigmentation: Day 15 | 21 | 31 |
| Hypopigmentation: Day 29 | 21 | 32 |
| Hypopigmentation: Day 57 | 21 | 29 |
| Hyperpigmentation: Baseline | 33 | 36 |
| Hyperpigmentation: Day 5 | 30 | 33 |
| Hyperpigmentation: Day 8 | 30 | 34 |
| Hyperpigmentation: Day 15 | 27 | 32 |
| Hyperpigmentation: Day 29 | 24 | 29 |
| Hyperpigmentation: Day 57 | 25 | 25 |
| Scarring: Baseline | 9 | 11 |
| Scarring: Day 5 | 8 | 13 |
| Scarring: Day 8 | 8 | 11 |
| Scarring: Day 15 | 9 | 9 |
| Scarring: Day 29 | 8 | 9 |
| Scarring: Day 57 | 10 | 9 |
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Participants with AE | 73 | 71 |
| Participants with any TEAE | 67 | 67 |
| Participants with any SAE | 4 | 1 |
| Participants with events of special interest | 4 | 4 |
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Participants with any AE | 0 | 2 |
| Participants with any SAE | 0 | 0 |
| Participants with events of special interest | 1 | 0 |
Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Hematology | 0 | 0 |
| Blood chemistry | 4 | 0 |
| Urinalysis | 0 | 1 |
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Number of Participants With Clinically Significant Safety Observations- Vital Signs | 0 | 0 |
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Number of Participants With Clinically Significant Safety Observations- Physical Examination | 0 | 0 |
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
| Participants | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs) | 0 | 0 |
Collected over From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/173 (0%) | 4/173 (2.3%) | 72/173 (41.6%) |
| KX2-391 Ointment 1% | 0/178 (0%) | 1/178 (0.6%) | 72/178 (40.4%) |
| Event | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/173 | 0/178 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 1/173 | 0/178 |
| Atrioventricular block completeCardiac disorders | 1/173 | 0/178 |
| BacteraemiaInfections and infestations | 1/173 | 0/178 |
| Chest painGeneral disorders | 1/173 | 1/178 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/173 | 1/178 |
| Event | Placebo | KX2-391 Ointment 1% |
|---|---|---|
| Application site painGeneral disorders | 5/173 | 24/178 |
| Application site pruritusGeneral disorders | 13/173 | 19/178 |
| Upper respiratory tract infectionInfections and infestations | 10/173 | 8/178 |
| Viral upper respiratory tract infectionInfections and infestations | 4/173 | 9/178 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/173 | 3/178 |
| Skin abrasionInjury, poisoning and procedural complications | 3/173 | 4/178 |
| SinusitisInfections and infestations | 3/173 | 0/178 |
| Urinary tract infectionInfections and infestations | 3/173 | 1/178 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/173 | 3/178 |
| Squamous cell carcinoma of head and neckNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/173 | 0/178 |
Intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | Placebo | KX2-391 Ointment 1% | Total |
|---|---|---|---|
| Mean | 70.2 ± 8.86 | 69.1 ± 8.69 | 69.7 ± 8.78 |
| Sex: Female, Male(Participants) | Placebo | KX2-391 Ointment 1% | Total |
|---|---|---|---|
| Female | 23 | 20 | 43 |
| Male | 150 | 158 | 308 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | KX2-391 Ointment 1% | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 11 | 19 |
| Not Hispanic or Latino | 165 | 167 | 332 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | KX2-391 Ointment 1% | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 173 | 177 | 350 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Number of AK lesions at baseline(lesions) | Placebo | KX2-391 Ointment 1% | Total |
|---|---|---|---|
| Mean | 5.8 ± 1.20 | 6.0 ± 1.27 | 5.9 ± 1.24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in May 2018, 7 months.
Results were first posted in Mar 2021, 2 years 10 months after primary completion. A results delay was requested in May 2020.
Of 26 phase 3 interventional studies under Keratosis, Actinic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topical Tirbanibulin