ScarNCT04169490
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
A study testing FS2 Emulsion Moisturizer, Active Comparator Onion Skin Extract Gel (Mederma) and Active Comparator Silicone Gel (Kelo-Cote) in people with Scar and Keloid, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar, Keloid, Hypertrophic Scar
- What is being tested?
- FS2 Emulsion Moisturizer, Active Comparator Onion Skin Extract Gel (Mederma) and Active Comparator Silicone Gel (Kelo-Cote)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
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"
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.
Read the 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.
- Conditions
- Scar, Keloid, Hypertrophic Scar, Cicatrix
- Being tested
- 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
- Keywords
- Scar, Keloid, Hypertrophic Scar, Cicatrix
- Medical subject headings
- Cicatrix, Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Cream Base Emulsion MoisturizerOther
Topical placebo white, oil/water emulsion moisturizer applied b.d. for 120 days
FS2 Emulsion MoisturizerOther
Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
Active Comparator Onion Skin Extract Gel (Mederma)Other
Topical onion skin extract gel (Mederma) applied b.d. for 120 days
Active Comparator Silicone Gel (Kelo-Cote)Other
Topical silicone gel (Kelo-Cote) applied b.d. for 120 days
Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion MoisturizerOther
Topical silicone gel (Kelo-Cote) + Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Active Comparator Silicone Gel (Kelo-Cote); Other: Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start7 Feb 2019
- Primary completion4 Sep 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- BirchBioMed Inc.
- Responsible party
- Principal investigator, Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research
- Investigators
- Mark S Nestor, M.D., Ph.D., Principal investigator, The Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169490
- Sponsor's protocol ID
- CCCR 02-2019
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04169490
- Acronym / sponsor ID
- CCCR 02-2019
- Conditions
- Scar, Keloid, Hypertrophic Scar, Cicatrix
- Keywords
- Scar, Keloid, Hypertrophic Scar, Cicatrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- BirchBioMed Inc.
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FS2 Emulsion Moisturizer | Experimental | Other: Placebo Cream Base Emulsion Moisturizer, Other: FS2 Emulsion Moisturizer, Other: Active Comparator Onion Skin Extract Gel (Mederma)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. |
| Active Comparator + FS2 Emulsion Moisturizer | Experimental | Other: Active Comparator Silicone Gel (Kelo-Cote), Other: Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion MoisturizerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Adult, Senior (>18 years of age)
- Healthy or medically stable
- Keloid or hypertrophic scar
- Willing and able to follow study requirements
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Cream Base Emulsion MoisturizerTopical placebo white, oil/water emulsion moisturizer applied b.d. for 120 days | Other | FS2 Emulsion Moisturizer |
| FS2 Emulsion MoisturizerTopical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days | Other | FS2 Emulsion Moisturizer |
| Active Comparator Onion Skin Extract Gel (Mederma)Topical onion skin extract gel (Mederma) applied b.d. for 120 days | Other | FS2 Emulsion Moisturizer |
| Active Comparator Silicone Gel (Kelo-Cote)Topical silicone gel (Kelo-Cote) applied b.d. for 120 days | Other | Active Comparator + FS2 Emulsion Moisturizer |
| Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion MoisturizerTopical silicone gel (Kelo-Cote) + Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days | Other | Active Comparator + FS2 Emulsion Moisturizer |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: 180 Days
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)
Time frame: 180 Days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- BirchBioMed Inc.Link provided by the sponsor.
- MedermaLink provided by the sponsor.
- Kelo-CoteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nestor, M.D., Ph.D. principal investigator
The Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS2 Emulsion Moisturizer, Active Comparator Onion Skin Extract Gel (Mederma) and Active Comparator Silicone Gel (Kelo-Cote) in people with Scar and Keloid, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: 180 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.