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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-11-08

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No-treatment control

Group Type EXPERIMENTAL

No-treatment control

Intervention Type OTHER

No-treatment control

Treatment

Intradermal injection Restylane Lidocaine

Group Type EXPERIMENTAL

Restylane Lidocaine

Intervention Type DEVICE

Hyaluronic acid based filler

Interventions

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Restylane Lidocaine

Hyaluronic acid based filler

Intervention Type DEVICE

No-treatment control

Intervention Type OTHER

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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes