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

August 24, 2022 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • Darmstadt
      • Munich, Germany
        • Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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
Time Frame: Month 3
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)
Time Frame: Month 1, Month 3
Assessed by blinded evaluator
Month 1, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

November 8, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05DF1605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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