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

Primary Purpose

Scar, Keloid, Hypertrophic Scar

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Cream Base Emulsion Moisturizer
FS2 Emulsion Moisturizer
Active Comparator Onion Skin Extract Gel (Mederma)
Active Comparator Silicone Gel (Kelo-Cote)
Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer
Sponsored by
The Center for Clinical and Cosmetic Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Scar, Keloid, Hypertrophic Scar, Cicatrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects who are medically unstable
  2. Subjects who are expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
  3. Pregnant subjects, or those attempting to become pregnant
  4. Subjects with known immunosuppression or immunosuppressive illness
  5. Subjects with uncontrolled diabetes or autoimmune disorders
  6. Subjects with known sensitivity to ingredients in the test-treatment products
  7. 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
  8. Subjects who have received scar treatment, including any investigational treatment, within one month of the first day of study treatment
  9. Subjects with any skin conditions or taking any medications that may interfere with the study medication
  10. Subjects who had any clinical evidence of severe ongoing or prolonged depression, mental illness, and/or who has demonstrated evidence of drug abuse
  11. 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

Sites / Locations

  • The Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FS2 Emulsion Moisturizer

Active Comparator + FS2 Emulsion Moisturizer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
March 7, 2022
Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
BirchBioMed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04169490
Brief Title
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
Official Title
"A Prospective, Randomized, Double-blind, Placebo Controlled and Comparative Clinical Study Evaluating Scar-management Modalities for Simple and Effective Management of Hyperproliferative (Hypertrophic) Scars and Keloids"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
September 4, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
BirchBioMed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Unlike raised and, or hyperproliferative scars that result from aberrant wound healing, keloids are the result of inherited genetic mutations in a variety of proteins essential to orchestrated wound repair. Whereas hyperproliferative scars may have shared similar abnormalities throughout the repair of a primary injury, they are not predictors of subsequent scarring following scar revision. Keloids on the other hand will return upon excision, and in some cases larger in size than the excised scar tissue. Current treatment options for keloids as well as hypertrophic scars include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. Onion skin extract, silicone, and a variety of over-the-counter selfcare product options are available for patients with keloids and hypertrophic scars. Despite market approval, robust efficacy data to substantiate product claims is scarce. At best, comparative studies have been able to demonstrate significance between modalities/products. With only a limited number of investigator initiated studies with scar-patients the advancement in this niche, yet expansive, medical sector has been incremental across decades of research. This study is being undertaken to investigate the efficacy and safety of a FS2- moisturizer, and two market-approved scar topical therapies. The FS2- moisturizer is claimed to be substantially equivalent or superior to market approved Onion skin extract (Mederma), and silicone gel (Kelo-Cote)intended to manage and improve hyperproliferative closed scars. The study builds upon a recent study that investigated safety and efficacy of a petrolatum lotion vs. onion-extract gel vs. placebo in subjects with hypertrophic scars and keloids. There two (2) Study Arms and five (5) Treatment Groups. Treatment Groups consist of: placebo moisturizer cream base, Onion skin extract (Mederma), FS2-moisturizer formulations, silicone gel (Kelo-Cote), and an FS2-silicone gel. 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 team member will administer the treatment, as well as answer questions and discuss any problems prior to starting, and for the duration of, the study. Subjects will be assigned a Treatment Group from those listed above. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Keloid, Hypertrophic Scar, Cicatrix
Keywords
Scar, Keloid, Hypertrophic Scar, Cicatrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS2 Emulsion Moisturizer
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator + FS2 Emulsion Moisturizer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Cream Base Emulsion Moisturizer
Intervention Description
Topical placebo white, oil/water emulsion moisturizer applied b.d. for 120 days
Intervention Type
Other
Intervention Name(s)
FS2 Emulsion Moisturizer
Intervention Description
Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
Intervention Type
Other
Intervention Name(s)
Active Comparator Onion Skin Extract Gel (Mederma)
Intervention Description
Topical onion skin extract gel (Mederma) applied b.d. for 120 days
Intervention Type
Other
Intervention Name(s)
Active Comparator Silicone Gel (Kelo-Cote)
Intervention Description
Topical silicone gel (Kelo-Cote) applied b.d. for 120 days
Intervention Type
Other
Intervention Name(s)
Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer
Intervention Description
Topical silicone gel (Kelo-Cote) + Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
Primary Outcome Measure Information:
Title
Vancouver Scar Scale (VSS)
Description
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.
Time Frame
180 Days
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
180 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nestor, M.D., Ph.D.
Organizational Affiliation
The Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.birchbiomed.com
Description
BirchBioMed Inc.
URL
https://www.mederma.com/
Description
Mederma
URL
https://kelocote.com/
Description
Kelo-Cote

Learn more about this trial

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

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