CompletedNCT04917588SayLipUpdated Mar 14, 2025Results posted

Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip Augmentation

An interventional study of Saypha® FILLER Lidocaine (HQ) and Saypha® FILLER Lidocaine (C1) in Abnormal Lip, sponsored by Croma-Pharma GmbH. Completed at 3 sites in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Croma-Pharma GmbH · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jul 2020, registered May 2021).

Phase: Not applicable
Study type: Interventional
Enrollment: 114
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a prospective, open-label, multicentre, randomized study conducted to evaluate the effectiveness, safety and long-term safety of Saypha® FILLER Lidocaine for lip augmentation.

Read the detailed description

Following informed consent and screening, eligible subjects with moderate to severe deficiency of lip volume will be randomized to receive Saypha® FILLER Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the submucosa of the lips, and subjects will return for follow-up assessments at Week 3, 6, 26, 52 and optional at Week 76 after the treatment.

A Touch-up treatment may be done at Week 3, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity using the LFS, Lip Fullness Scale, at Week 6, 26, 52 after the treatment and optional at Week 76 and in comparison to Day 0. The upper and lower lip will be graded separately.

Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.

Conditions studied

Abnormal Lip

Keywords

Moderate to Severe Lip Volume Deficit

In context

Lead sponsor

Croma-Pharma GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Adult female or male subjects 18 years of age at Screening/Baseline visit (Visit 1)
Presence of approximately symmetrical "very thin" lips (minimal red lip shows) to "moderately thick" lips (moderate red lip shows) as assessed with the LFS (severity grade of 1 to 3 on both lips) as determined by the investigator at Visit 1
For females of childbearing potential only: negative urine pregnancy test at Visit 1, and must agree to use an highly effective method of contraception for the duration of the clinical investigation
Healthy skin in the treatment area and free of diseases that could interfere in evaluation of treatment
Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
Willingness to take part in this clinical investigation documented by a personally signed/dated informed consent.

Exclusion criteria

Exclusion Criteria:

Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
History of mental disorders or emotional instability
History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine or any amide-based anaesthetic
Prior surgery, scars or tattoo to the upper or lower lip or lip line; surgery and tattooing are prohibited until end of clinical investigation
Tooth gap, overbite, beard longer three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator
Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, chemical peeling, dermabrasion or mesotherapy within 12 months before Visit 1 and until end of clinical investigation
Previous permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) and until end of the investigation
Previous toxin treatment in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) within 9 months before Visit 1 and until end of clinical investigation
Presence of cutaneous lesions, inflammatory and/or infectious processes (e.g. acne, herpes, etc.) or proliferative lesions in the treatment area
Known human immune deficiency virus-positive individuals
History of allergies against aesthetic filling products and recurrent (3 times a year) herpes simplex in the treated area
Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
Uncontrolled systemic diseases (such as diabetes mellitus)
Use of anticoagulant, antiplatelet or thrombolytic medication (e.g. acetylsalicylic acid) from 10 days pre- to three days post IMD injections
Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior to initial IMD injection and to a minimum of four weeks post IMD injections
Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
Previous enrolment in this clinical investigation
Any dependent relationship of the subject with the investigator, investigation site or Sponsor (e.g. employees or relatives)
Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 114 participants (actual)

Study arms

Experimental
Saypha® FILLER HQ
Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma HQ Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).
Combination Product: Saypha® FILLER Lidocaine (HQ)
Active comparator
Saypha® FILLER C1
Eligible subjects will undergo bilateral lip augmentation treatments with Saypha® FILLER Lidocaine manufactured in the Croma Pharma C1 Facility in order to correct moderate to severe deficiency of lip volume. The treatment will be administered at the Baseline visit (Day 0).
Combination Product: Saypha® FILLER Lidocaine (C1)

Interventions

Combination productSaypha® FILLER Lidocaine (HQ)
Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.
Combination productSaypha® FILLER Lidocaine (C1)
Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.

What researchers measure

Primary outcomes

Responder Rate in Lip Volume Improvement
The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.
Time frame: Week 6

Secondary outcomes

Percentage of Responders Based on the Investigator Live Assessment
The percentage of responders (with the Lip Volume Improved by \>=1 Point Versus Baseline Value,) based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS. Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.
Time frame: 6, 12 and optional 18 months
Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
The percentage of responders based on the independent photographic reviewer´s assessments at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS (compared to Baseline). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal), Grade 2 (slight), Grade 3 (moderately thick), Grade 4 (thick), to Grade 5 (very significant): In this case, the bigger the number, the better.
Time frame: Week 6, Month 6, 12 and optional Month 18
Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
The percentage of subjects with an improvement relative to baseline photographs, (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the investigator assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment using the 5-point GAIS.
Time frame: Week 6, Month 6, 12 and optional Month 18
Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
The percentage of subjects with an improvement relative to baseline photographs (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment, using the 5-point GAIS with results ranging from 1 to 5 with lower numbers indicating better improvement
Time frame: Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction Using Face-Q Questionnaire
The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).
Time frame: Week 6, Month 6, 12 and optional Month 18
Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
The extent of subject's satisfaction with augmentation of lips, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire "Satisfaction with Lips", a 6-items Aesthetic Appearance Questionnaire with 5 pre-defined answer options between "very satisfied" and "very dissatisfied". The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q. The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).
Time frame: Week 6, Month 6, 12 and optional Month 18
Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
Subject's perception of pain after initial and touch-up treatment with Saypha® FILLER Lidocaine using the 11-point Numeric Pain Rating Scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable.
Time frame: Day1, Week 3
Percentage of Subjects Demonstrating an Aesthetic Effect
Percentage of subjects demonstrating an aesthetic effect at Week 6, Month 6, 12 and optional Month 18 based on the investigator's life assessment. A live assessment of the treated areas was performed and the treated areas compared to the subject's photographs obtained at the Baseline Visit. The presence of the aesthetic effect was recorded as either "Yes" or "No"
Time frame: Week 6, Month 6, 12 and optional Month 18
Injection Volume Required
Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.
Time frame: Day1, Week 3

Results

Posted Mar 14, 2025

Participant flow

Screened patients: N=121; Screening failures: N=7; Patients enrolled = Patients Treated with IMD: N= 114

Participant flow — Overall Study
Milestone	Saypha® FILLER HQ	Saypha® FILLER C1
Started	57	57
Completed	50	51
Not completed	7	6

Outcome measures

PrimaryResponder Rate in Lip Volume Improvement

The proportion of subjects ('responders') with the lip volume improved by ≥1 point versus baseline value at 6 weeks after initial treatment based on the investigator live assessment using the validated Lip Fullness Scale (LFS). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.

Time frame:: Week 6
Reported as:: Count of participants · Participants

Responder Rate in Lip Volume Improvement
Participants	Saypha® FILLER HQ	Saypha® FILLER C1	Overall Population (Saypha® FILLER HQ + Saypha® FILLER C1)
lower lip responders	55	52	107
upper lip responders	53	53	106

SecondaryPercentage of Responders Based on the Investigator Live Assessment

The percentage of responders (with the Lip Volume Improved by \>=1 Point Versus Baseline Value,) based on the investigator live assessment at 6, 12 and optional 18 months after the initial treatment using the validated LFS. Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal volume) to Grade 5 (very significant volume): In this case, the bigger the number, the better.

Time frame:: 6, 12 and optional 18 months
Reported as:: Count of participants · Participants

Percentage of Responders Based on the Investigator Live Assessment
Participants	Saypha® FILLER HQ	Saypha® FILLER C1	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Month 6 Lower Lips	48	50	98
Month 6 Upper Lips	49	50	99
Month 12 Lower Lips	41	36	77
Month 12 Upper Lips	38	36	74
Month 18 Lower Lips	28	23	51
Month 18 Upper Lips	24	19	43

SecondaryPercentage of Responders Based on the Independent Photographic Reviewer´s Assessments

The percentage of responders based on the independent photographic reviewer´s assessments at Week 6, Month 6, 12 and optional Month 18 after initial treatment, based on photographs and using the validated LFS (compared to Baseline). Lip Fullness Scale (LFS) is a validated 5-point rating scale,that evaluates the Lip Volume Deficiency ranging from Grade 1 (minimal), Grade 2 (slight), Grade 3 (moderately thick), Grade 4 (thick), to Grade 5 (very significant): In this case, the bigger the number, the better.

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Count of participants · Participants

Percentage of Responders Based on the Independent Photographic Reviewer´s Assessments
Participants	Saypha® FILLER HQ	Saypha® FILLER C1	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6 - Lower Lip	25	30	55
Week 6 - Upper Lip	17	25	42
Month 6 - Lower Lip	20	19	39
Month 6 - Upper Lip	15	24	39
Month 12 - Lower Lip	20	15	35
Month 12 - Upper Lip	20	26	46
Month 18 - Lower Lip	15	16	31
Month 18 - Upper Lip	13	21	34

SecondaryPercentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS

The percentage of subjects with an improvement relative to baseline photographs, (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the investigator assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment using the 5-point GAIS.

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Count of participants · Participants

Percentage of Subjects With an Improvement Based on the Investigator Assessment Using GAIS
Participants	Saypha® FILLER HQ	Saypha® FILLER C1	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6 -Lower Lip	56	54	110
Week 6 - Upper Lip	56	54	110
Month 6 - Lower Lip	53	53	106
Month 6 - Upper Lip	53	53	106
Month 12- Lower Lip	44	41	85
Month 12 - Upper Lip	44	40	84
Month 18 - Lower Lip	30	26	56
Month 18 -Upper Lip	30	21	51

SecondaryPercentage of Subjects With an Improvement Based on Subject Assessment Using GAIS

The percentage of subjects with an improvement relative to baseline photographs (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 6, Month 6, 12 and optional Month 18 after initial treatment, using the 5-point GAIS with results ranging from 1 to 5 with lower numbers indicating better improvement

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Count of participants · Participants

Percentage of Subjects With an Improvement Based on Subject Assessment Using GAIS
Participants	Saypha® FILLER HQ	Saypha® FILLER C1	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6 - lower lips	55	54	109
Week 6 - upper lips	56	54	110
Month 6 - Lower Lips	51	53	104
Month 6 - Upper Lips	53	53	106
Month 12 - Lower Lips	45	44	89
Month 12 - Upper Lips	44	44	88
Month 18 - Lower Lips	37	34	71
Month 18 - Upper Lips	34	35	69

SecondarySubject Satisfaction Using Face-Q Questionnaire

The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Mean · score on Face Q questionnaire

Subject Satisfaction Using Face-Q Questionnaire
score on Face Q questionnaire	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6	85.8 ± 17.88
Month 6	80.0 ± 20.61
Month 12	71.7 ± 25.53
Month 18	78.3 ± 25.76

SecondarySubject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"

The extent of subject's satisfaction with augmentation of lips, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q TM Questionnaire "Satisfaction with Lips", a 6-items Aesthetic Appearance Questionnaire with 5 pre-defined answer options between "very satisfied" and "very dissatisfied". The extent of subject´s satisfaction with overall outcome of the treatment, at Week 6, Month 6, 12 and optional Month 18 after initial treatment, assessed by the subject using the Face-Q. The raw summed scale score is converted to a score from 0 to 100 by using the respective Conversion Tables available from Face Q authors. Higher scores reflect a better outcome (i.e., 0 (worst) to 100 (best)).

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Mean · score Face Q questionnaire

Subject Satisfaction Using Face-Q TM Questionnaire "Satisfaction With Lips"
score Face Q questionnaire	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6	90.9 ± 11.96
Month 6	84.9 ± 17.24
Month 12	76.2 ± 22.69
Month 18	78.3 ± 20.45

SecondarySubject's Perception of Pain Using the 11-point Numeric Pain Rating Scale

Subject's perception of pain after initial and touch-up treatment with Saypha® FILLER Lidocaine using the 11-point Numeric Pain Rating Scale (NPRS), where 0 is no pain and 10 is the worst pain imaginable.

Time frame:: Day1, Week 3
Reported as:: Mean · score on a scale

Subject's Perception of Pain Using the 11-point Numeric Pain Rating Scale
score on a scale	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)	Saypha® FILLER HQ	Saypha® FILLER C1
Initial Treatment - Immediately after treatment	3.3 ± 1.71	3.6 ± 1.75	3.0 ± 1.62
Initial Treatment - 15 min post treatment	0.5 ± 0.92	0.7 ± 1.05	0.3 ± 0.73
Touch up (Week 3) - Immediately after treatment	2.9 ± 1.48	2.7 ± 1.52	3.0 ± 1.46
Touch up (Week 3 ) - 15 min post treatment	0.4 ± 0.65	0.4 ± 0.77	0.3 ± 0.53

SecondaryPercentage of Subjects Demonstrating an Aesthetic Effect

Percentage of subjects demonstrating an aesthetic effect at Week 6, Month 6, 12 and optional Month 18 based on the investigator's life assessment. A live assessment of the treated areas was performed and the treated areas compared to the subject's photographs obtained at the Baseline Visit. The presence of the aesthetic effect was recorded as either "Yes" or "No"

Time frame:: Week 6, Month 6, 12 and optional Month 18
Reported as:: Count of participants · Participants

Percentage of Subjects Demonstrating an Aesthetic Effect
Participants	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Week 6	110
Month 6	106
Month 12	86
Month 18	59

SecondaryInjection Volume Required

Injection volume (initial and touch-up) required for an optimal augmentation of the lips with Saypha® FILLER Lidocaine.

Time frame:: Day1, Week 3
Reported as:: Mean · ml

Injection Volume Required
ml	Overall Population ( Saypha® FILLER HQ + Saypha® FILLER C1)
Day 1 - initial treatment -lower lip	0.79 ± 0.282
Day 1 - Initial Treatment - Upper Lip	0.80 ± 0.285
Day 1 - initial treatment - both lips	1.59 ± 0.516
Week 3 - touch up treatment - lower lip	0.50 ± 0.298
Week 3 - touch up treatment - upper lip	0.51 ± 0.305
Week 3 - touch up treatment - both lips	0.85 ± 0.604

Adverse events

Collected over Adverse events (AEs) were documented from the time of first IMD application at Baseline visit (Visit 1) throughout the course of the clinical investigation, which means up to 18 months after IMD application.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Saypha® FILLER HQ	0/57 (0%)	0/57 (0%)	35/57 (61.4%)
Saypha® FILLER C1	0/57 (0%)	1/57 (1.8%)	32/57 (56.1%)

Most frequent serious events

Most frequent serious events
Event	Saypha® FILLER HQ	Saypha® FILLER C1
DepressionPsychiatric disorders	0/57	1/57

Most frequent other events

Most frequent other events
Event	Saypha® FILLER HQ	Saypha® FILLER C1
Application site painGeneral disorders	26/57	21/57
Injection site swellingGeneral disorders	18/57	16/57
Injection Site BruisingGeneral disorders	17/57	16/57
COVID 19Infections and infestations	11/57	7/57

Baseline characteristics

Population considered for this analysis is the Full Analysis Set (FAS) which comprises all subjects who received at least 1 administration of the IMD and who had at least 1 post-treatment evaluation of the LFS.

Age, Continuous
Age, Continuous(years)	Saypha® FILLER HQ	Saypha® FILLER C1	Total
Mean	42.1 ± 13.78	44.4 ± 16.22	43.2 ± 15.03

Sex: Female, Male
Sex: Female, Male(Participants)	Saypha® FILLER HQ	Saypha® FILLER C1	Total
Female	57	57	114
Male	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Saypha® FILLER HQ	Saypha® FILLER C1	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	57	57	114
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Saypha® FILLER HQ	Saypha® FILLER C1	Total
Austria	57	57	114

Smoking habit
Smoking habit(Participants)	Saypha® FILLER HQ	Saypha® FILLER C1	Total
current	21	22	43
former	4	4	8
never smoked	32	31	63

Study locations

3 sites

Medizinisch Aesthetisches Zentrum Wien
Vienna, 1010, Austria
YUVELL - Home of Aesthetics
Vienna, 1010, Austria
PW-Privatklinik Waehring GmbH
Vienna, 1180, Austria

References and documents

Study documents

Study protocol · Jun 27, 2019
Statistical analysis plan · Jun 7, 2021

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04917588
Lead sponsor: Croma-Pharma GmbH
Responsible party: Sponsor
First posted: Jun 8, 2021
Start date: Jul 28, 2020
Primary completion: Dec 14, 2020
Completion: Apr 6, 2022
Results posted: Mar 14, 2025
Last update: Mar 14, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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