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

NCT04169490 | Completed

• 1 other identifier: CCCR 02-2019
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Scar; Keloid; Hypertrophic Scar; Cicatrix

Outcome Measures

Primary Outcomes (2)

• Vancouver Scar Scale (VSS)

  Investigator assessment of target scar or keloid using the Vancouver Scar Scale (VSS). Scale parameters include: Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), and Height (0-3). Scale measurements include: minimum score of 0 = normal to a maximum score of 2, 3 or 5 depending on the parameter measured.

  180 Days

• Patient and Observer Scar Assessment Scale (POSAS)

  Investigator assessment of target scar or keloid using the Patient and Observer Scar Assessment Scale (POSAS). Scale parameters include: Vascularity, Pigmentation, Thickness, Relief, Pliability, and Surface Area. Scale measurements include: minimum score of 1 = normal skin to a maximum score of 10 = worst scar imaginable.

  180 Days

Study Arms (2)

FS2 Emulsion Moisturizer

EXPERIMENTAL

The FS2 Emulsion Moisturizer Arm is comprised of three (3) topical treatments including: Placebo Cream Base Emulsion Moisturizer, FS2 Emulsion Moisturizer and Active Comparator Onion Skin Extract Gel (Mederma). The topical treatments are applied b.d. for 120 days.

Other: Placebo Cream Base Emulsion Moisturizer; Other: FS2 Emulsion Moisturizer; Other: Active Comparator Onion Skin Extract Gel (Mederma)

Active Comparator + FS2 Emulsion Moisturizer

EXPERIMENTAL

The Active Comparator + FS2 Emulsion Moisturizer Arm is comprised of two (2) topical treatments including: Active Comparator Silicone Gel (Kelo-Cote), and Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer. The topical treatments are applied b.d. for 120 days.

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

Interventions

Placebo Cream Base Emulsion Moisturizer OTHER

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

FS2 Emulsion Moisturizer

FS2 Emulsion Moisturizer OTHER

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

FS2 Emulsion Moisturizer

Active Comparator Onion Skin Extract Gel (Mederma) OTHER

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

FS2 Emulsion Moisturizer

Active Comparator Silicone Gel (Kelo-Cote) OTHER

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

Active Comparator + FS2 Emulsion Moisturizer

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

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

Active Comparator + FS2 Emulsion Moisturizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Adult, Senior (\>18 years of age)
• Healthy or medically stable
• Keloid or hypertrophic scar
• Willing and able to follow study requirements
• Etiology and clinical assessment of the scar indicate that it could benefit from the study treatments

You may not qualify if:

• Subjects who are medically unstable
• Subjects who are expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
• Pregnant subjects, or those attempting to become pregnant
• Subjects with known immunosuppression or immunosuppressive illness
• Subjects with uncontrolled diabetes or autoimmune disorders
• Subjects with known sensitivity to ingredients in the test-treatment products
• Subjects who are enrolled in another scar study and/or plan to receive or are receiving scar treatments other than study treatment during the trial period
• Subjects who have received scar treatment, including any investigational treatment, within one month of the first day of study treatment
• Subjects with any skin conditions or taking any medications that may interfere with the study medication
• Subjects who had any clinical evidence of severe ongoing or prolonged depression, mental illness, and/or who has demonstrated evidence of drug abuse
• Any other diagnosis, condition, physical or geographical limitation that may render, or increases the likelihood of rendering, the Subject unable to complete the entire study

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• BirchBioMed Inc.: collaborator

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Links

• BirchBioMed Inc.
• Mederma
• Kelo-Cote

MeSH Terms

Conditions

Cicatrix; Keloid; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark S Nestor, M.D., Ph.D.

  The Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded study, which means that neither the evaluating physician nor the subject will know which treatment is administered. A separate study staff member will administer the treatment, as well as answer questions and discuss any problems prior to starting, and for the duration of, the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: The study consists of five Treatments across two study Arms of which include a placebo, a 510(k) market-approved "Active" comparator with and without FS2, and two cosmetic, moisturizer formulation variants that have not demonstrated therapeutic efficacy, but are hypothesized to improve the appearance of scar-prone wounds once healed. The Placebo moisturizer serves as the negative control, whereas the silicone gel serves both purposes as a negative control for the FS2 incorporated silicone gel and active comparator for both FS2 silicone gel and the moisturizing products.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 20, 2019
• Study Start: February 7, 2019
• Primary Completion: September 4, 2020
• Study Completion: November 3, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)