Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02955381
Status:
TERMINATED
Last Update Posted:
2019-05-10
First Post:
2016-11-02
Brief Title:
Restylane Silk Acne Scar Efficacy Evaluation Study
Sponsor:
Schweiger Dermatology PLLC
Organization:
Schweiger Dermatology PLLC
Study Overview
Official Title:
6 Month Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Small Particle Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Liquidation of Research Department
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized double-blind placebo-controlled research pilot study 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures Subjects must have at least 1 but up to 3 acne scars 3 mm or 10 mm located on the cheeks or forehead Subjects will receive one treatment Restylane Silk or Placebo in each scar at day 0 and Month 1 2 total treatments per scar during the study Subjects will be asked to come to 10 visits Screening visit up to 35 days prior to Baseline Baseline Day 0 Day 7 Day 14 Month 1 Month 2 Month 3 Month 4 Month 5 and Month 6 study exit visit The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema bruising inflammation itching stingingburning brightness fullness smoothness and clarity Safety and adverse events will be captured at each visit only by the unblinded investigator
Detailed Description:
Randomized double-blind placebo-controlled research pilot study 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures Subjects must have at least 1 but up to 3 acne scars 3 mm or 10 mm located on the cheeks or forehead Subjects will receive one treatment Restylane Silk or Placebo in each scar at day 0 and Month 1 2 total treatments per scar during the study Subjects will be asked to come to 10 visits Screening visit up to 35 days prior to Baseline Baseline Day 0 Day 7 Day 14 Month 1 Month 2 Month 3 Month 4 Month 5 and Month 6 study exit visit The blinded investigators will evaluate the target scar using the Acne Scar Rating Scale ASRS rate the target acne scar regarding treatment effect on a -5 Markedly worse to 0 Neutral Improvement to 5 Markedly Improved Clear or nearly clear point scale and evaluate the skin quality regarding brightness fullness smoothness and clarity Subjects will give the acne scar a score on the subject VAS acne scar satisfaction scale marking between 0 Not satisfied with Acne Scar at Day 0 and 10 Extremely Satisfied with Acne Scar at Day 0 The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema bruising inflammation itching stingingburning brightness fullness smoothness and clarity The subject will have their vital signs taken complete a symptom diary only if the subject experiences side effects or adverse events complete a DLQI and have photos VECTRA and 2D digital photographs taken of the treatment area Efficacy measures will only be completed by the blinded investigator Safety and adverse events will be captured at each visit only by the unblinded investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None