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

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

Arm && Interventions

Group	Intervention	Description
No-treatment control	No-treatment control	-
Treatment	Restylane Lidocaine	Intradermal injection Restylane Lidocaine

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