Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision (NCT03876548) | Clinical Trial Compass
WithdrawnEarly Phase 1
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
Stopped: Recruitment Challenges
United States0Started 2019-02-07
Plain-language summary
This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.
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 18 years or older
. Subject is healthy, as determined by the investigator based on a medical evaluation and history
. Subject has an established diagnosis of keloid scar formation
. Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
. Subject has one or more keloids eligible for scar revision
. Subject has a keloid of appropriate size (1 to 2.5 cm in length, 4 to 5 mm in width, and 3 to 4 mm in height)
. Subject has no known allergies to study products
. Subject is willing and able to avoid total body water exposure from large bodies of water such as pools, lakes, oceans, etc. while using study medication
Exclusion criteria
. Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
. Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
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
Scar measurement with Silhouette Camera Imaging
Timeframe: 24 weeks
2
Patient and Observer Scar Assessment Scale (Subject facing)
Timeframe: 24 weeks
3
Patient and Observer Scar Assessment Scale (Non-Subject facing)
. Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
. Subject has a past history of coagulopathy
. Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
. Subject is treated with anticoagulants or antiplatelet therapies
. Subject has a known allergy or sensitivity to any local anesthetic (such as lidocaine) or a local topical antiseptic that may be used (such as iodine)
. Subject has known allergic reaction to the study product