Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars

Phase 4

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT03127384
• Lead Sponsor: Galderma R&D

Brief Summary

The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2018-02-15
• Study Completion: 2018-11-08
• Status Verified: 2019-09
• Results First Submitted: 2019-09-11
• Results First Submitted QC: 2019-09-11
• Results First Posted: 2019-10-03
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek	Month 3	Overall scar severity assessed by blinded evaluator.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)	Month 1, Month 3	Assessed by blinded evaluator

Trial Locations

Locations (2)

Darmstadt; 🇩🇪 Darmstadt, Germany

Munich; 🇩🇪 Munich, Germany