Phase 4
Completed N=49
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Healthy Volunteers
Source: ClinicalTrials.gov NCT03127384 ↗
Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek — 81 percentage of participants
◆ Published Evidence
Established
43citations · ~5 / year
Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel.
Summary
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
Linked Publications
-
Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek |
81 | — |
| SECONDARY Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) |
0; 96; 6; 83 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03127384) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.