COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis (NCT06726707) | Clinical Trial Compass
WithdrawnPhase 2/3
COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis
Stopped: At the discretion of the sponsor
0Started 2025-09-01
Plain-language summary
As there are currently no evidence on the benefit of absorbing incontinence products with copper to stabilize IAD in the elderly, thus, this study will assess the capacity and safety of an absorbing incontinence products with a copper-based substance for the management of adults with incontinence-associated dermatitis, compared to an absorbing incontinence products with no substance. This approach may contribute for IAD management arsenal, since clinical evidence on the efficiency of products available in the market to manage IAD is frail, as seen in systematic reviews mentioned above. We believe copper, as a barrier product, has the potential to perform well in this clinical setting of IAD, as it performed well in other settings.
Who can participate
Age range
60 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:
* Ability and capability to participate in the study and follow study procedures as determined by the investigator.
* With moderate or more intense urinary (ISI ≥ 3) and/or fecal incontinence (Pescatori et al. (B1, B2, B3, C1, C2, C3);
* Current users of absorbing incontinence products.
* Diagnosed with incontinence-associated dermatitis GLOBIAD 1A or 2A.
Exclusion Criteria:
* Incontinence-associated dermatitis GLOBIAD 1B or 2B;
* The subject who knows about allergy or a history of an adverse reaction to product ingredients or to any topical preparations or skincare products;
* The subject who has an active skin condition or a history of recurrent skin conditions, except IAD, that may affect IAD healing;
* The subject who was treated in the previous week with systemic or topical agents (except for IAD) that may affect IAD healing process (e.g., steroids);
* Subject with a score \< 10 in Mini Nutritional Assessment - Short Form;
* Subjects with diabetes.
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.