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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127384
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: Restylane Lidocaine Other: No-treatment control Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Month 1, Month 3 ]
    Assessed by blinded evaluator



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127384


Locations
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Germany
Darmstadt
Darmstadt, Germany
Munich
Munich, Germany
Sponsors and Collaborators
Q-Med AB
Investigators
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Study Director: Study Director Q-Med AB
  Study Documents (Full-Text)

Documents provided by Q-Med AB:

Publications of Results:
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03127384    
Other Study ID Numbers: 05DF1605
First Posted: April 25, 2017    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Lidocaine
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents