Phase 4
N=49
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03127384 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek — 81 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Restylane Lidocaine (Device); No-treatment control (Other)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek |
81 | — |
| SECONDARY Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) |
0; 96; 6; 83 | — |
Summary
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
Eligibility Criteria
Inclusion Criteria
- Intent to undergo treatment of depressed acne scars
- Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
- Similar type, size and number of scars on both cheeks
- Men or non-pregnant, non-breast feeding women
- Fitzpatrick skin type I-IV
- Signed and dated informed consent to participate in the study
Exclusion Criteria
- Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of > 4 mm.
- Active acne with inflammatory component
- Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
- Use of isotretinoin within 6 months before treatment
- Post-surgical scars in the treatment area
- Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area
- Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment
- Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment
- Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment
- Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area
- Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Data sourced from ClinicalTrials.gov (NCT03127384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.