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Restylane Silk Acne Scar Efficacy Evaluation Study

NCT02955381 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-05-10

No results posted yet for this study

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, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.

Conditions

  • Acne
  • Acne Scars
  • AdverseEvent

Interventions

DEVICE

Restylane Silk, 1.0 ml

Restylane® Silk was approved in 2014 submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.

DEVICE

Saline, 1.0 ml

Simple saline solution. To be used as placebo (control). No active ingredients.

Sponsors & Collaborators

  • Schweiger Dermatology, PLLC

    lead INDUSTRY

Principal Investigators

  • Eric S Schweiger, M.D. · CEO & Chief Medical Officer

  • Margaret J Tropeano, BS · Clinical Research Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2019-04-18
Completion
2019-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955381 on ClinicalTrials.gov