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

Galderma

Status and phase

Completed

Phase 4

Conditions

Healthy Volunteers

Treatments

Device: Restylane Lidocaine

Other: No-treatment control

Study type

Interventional

Funder types

Industry

Identifiers

NCT03127384

05DF1605

Details and patient eligibility

About

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

Enrollment

49 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)