Clinical trial NCT03127384: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 1, Month 3
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Darmstadt
city: Munich
country: Germany
facility: Munich
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References:
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.