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"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"

NCT04169490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-03-21

No results posted yet for this study

Summary

A Phase II prospective, randomized, double-blind, placebo controlled and comparative clinical study evaluating hydrogel scar-management modalities for effective management of hyperproliferative scars and keloids.

This is a double-blinded study, which means that neither the evaluating physician nor the subject will know which treatment is administered.

Group selection and assignment will be made at random, with a 2 in 5 chance of receiving a market-approved therapy, and 1 in 5 chance of receiving the placebo. Subjects assigned the placebo-moisturizer will receive a standard hypoallergenic dermatological hydrating cream base. Subjects assigned the silicone gel, will receive a commercially available, active comparator.

Conditions

  • Scar
  • Keloid
  • Hypertrophic Scar
  • Cicatrix

Interventions

OTHER

Placebo Cream Base Emulsion Moisturizer

Topical placebo white, oil/water emulsion moisturizer applied b.d. for 120 days

OTHER

FS2 Emulsion Moisturizer

Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days

OTHER

Active Comparator Onion Skin Extract Gel (Mederma)

Topical onion skin extract gel (Mederma) applied b.d. for 120 days

OTHER

Active Comparator Silicone Gel (Kelo-Cote)

Topical silicone gel (Kelo-Cote) applied b.d. for 120 days

OTHER

Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer

Topical silicone gel (Kelo-Cote) + Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days

Sponsors & Collaborators

  • BirchBioMed Inc.

    collaborator UNKNOWN

  • The Center for Clinical and Cosmetic Research

    lead OTHER

Principal Investigators

  • Mark S Nestor, M.D., Ph.D. · The Center for Clinical and Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-09-04
Completion
2020-11-03

Countries

  • United States

Study Locations

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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 NCT04169490 on ClinicalTrials.gov