Clinical trial NCT04169490: "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
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keloid
Hypertrophic Scar
Cicatrix
Keywords: Scar
Keloid
Hypertrophic Scar
Cicatrix
Lead sponsor: The Center for Clinical and Cosmetic Research
Sponsor class: OTHER
Collaborators: name: BirchBioMed Inc.
First posted: 2019-11-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vancouver Scar Scale (VSS)
timeFrame: 180 Days
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 180 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
Study officials:
affiliation: The Center for Clinical and Cosmetic Research
name: Mark S Nestor, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: