"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities" (NCT04169490) | Clinical Trial Compass
CompletedNot Applicable
"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
United States75 participantsStarted 2019-02-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vancouver Scar Scale (VSS)
Timeframe: 180 Days
2
Patient and Observer Scar Assessment Scale (POSAS)
Timeframe: 180 Days
Trial details
NCT IDNCT04169490
SponsorThe Center for Clinical and Cosmetic Research
. 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