Back to resultsPerformance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Restylane Lidocaine
No-treatment control
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
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)
Sites / Locations
- Darmstadt
- Munich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
No-treatment control
Treatment
Arm Description
Intradermal injection Restylane Lidocaine
Outcomes
Primary Outcome Measures
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Overall scar severity assessed by blinded evaluator.
Secondary Outcome Measures
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Assessed by blinded evaluator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03127384
Brief Title
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No-treatment control
Arm Type
Experimental
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intradermal injection Restylane Lidocaine
Intervention Type
Device
Intervention Name(s)
Restylane Lidocaine
Intervention Description
Hyaluronic acid based filler
Intervention Type
Other
Intervention Name(s)
No-treatment control
Intervention Description
No-treatment control
Primary Outcome Measure Information:
Title
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Description
Overall scar severity assessed by blinded evaluator.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Description
Assessed by blinded evaluator
Time Frame
Month 1, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Darmstadt
City
Darmstadt
Country
Germany
Facility Name
Munich
City
Munich
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30358630
Citation
Dierickx C, Larsson MK, Blomster S. Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel. Dermatol Surg. 2018 Nov;44 Suppl 1:S10-S18. doi: 10.1097/DSS.0000000000001689.
Results Reference
result
Learn more about this trial
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
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