COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis

NCT06726707 | Withdrawn Phase 2 DMC

• 1 other identifier: COPPER_Trial
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Incontinence-associated Dermatitis

Keywords

urinary incontinence; fecal incontinence; copper

Outcome Measures

Primary Outcomes (1)

• Proportion of non-progressing IAD 14 days

  Proportion of non-progressing IAD after 14 days from randomization start by GLOBIAD criterion.

  14 days

Secondary Outcomes (6)

• Proportion of non-progressing IAD 28 days

  28 days

• Pain assessment

  14 and 28 days

• Quality of life SF12

  28 days

• Skin health by skin health assessment tool

  14 and 28 days

• Time to resolution of IAD

  From enrollment to resolution, mean of 4 to 7 days

Study Arms (2)

Copper-based product

EXPERIMENTAL

Individuals enrolled in the treatment with diapers embedded with a copper-based product plus usual care

Combination Product: Diaper with a copper-based product + usual care

Control

ACTIVE COMPARATOR

Individuals enrolled in the treatment with common diapers plus usual care

Combination Product: Barrier product with common diaper

Interventions

Diaper with a copper-based product + usual care COMBINATION_PRODUCT

The intervention is an incontinence aid product and its performance is related to its ability to absorb and contain urine/ feces as well as keeping the skin dry.

Copper-based product

Barrier product with common diaper COMBINATION_PRODUCT

The common diaper is an incontinence aid and its performance is related to its ability to absorb and contain urine/ feces as well as keeping the skin dry.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Essity Hygiene and Health AB: collaborator

MeSH Terms

Conditions

Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Henrique A Rodrigues da Fonseca, PhD

  Hospital Israelita Albert Einstein - ARO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory trial

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share