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 range60 Years

SexALL

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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.

What they're measuring

Proportion of non-progressing IAD 14 days

Timeframe: 14 days

Trial details

NCT IDNCT06726707

SponsorHospital Israelita Albert Einstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30