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

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

Official Title
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A Randomised, Evaluator-blind Comparative Study to Evaluate Performance and Safety of Restylane Lidocaine and No-treatment Control for Treatment of Depressed Facial Acne Scars

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Restylane Lidocaine
* Other: No-treatment control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No-treatment control<br> | Other: No-treatment control<br>* No-treatment control<br>|
| Experimental: Treatment<br>Intradermal injection Restylane Lidocaine | Device: Restylane Lidocaine<br>* Hyaluronic acid based filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek | Overall scar severity assessed by blinded evaluator. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Assessed by blinded evaluator | Month 1, Month 3 |