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

COPPER: An Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory Trial, Evaluating the Management of Incontinence-Associated Dermatitis Using Copper Containing Absorbing Incontinence Products

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.

Study Overview

• Status: Withdrawn
• Conditions: Incontinence-associated Dermatitis
• Intervention / Treatment: Combination product: Diaper with a copper-based product + usual care; Combination product: Barrier product with common diaper

Detailed Description

This study adopts an exploratory trial design with an adaptive approach. It is randomized, multicenter, controlled, and double-blinded, with parallel groups and blinded outcome adjudication. The study hypothesis suggests that incontinence products infused with copper-based substances may provide superior stabilization of IAD compared to control products.

The primary objective of the study is to evaluate the effectiveness of absorbing incontinence products containing a copper-based substance in stabilizing incontinence-associated dermatitis (IAD) in adults with moderate to severe urinary and/or fecal incontinence. This will be compared against standard absorbing incontinence products without copper-based substances, with both groups receiving usual care. Secondary objectives include assessing improvements in pain within 14 and 28 days, evaluating quality of life improvements over 28 days, and measuring changes in skin health scores from baseline to 14 and 28 days.

Participants will be adults aged 60 years or older, experiencing moderate to severe urinary and/or fecal incontinence. Eligibility will be determined using specific scales outlined in the study rationale. Recruitment will target individuals in long-term care facilities or hospital wards located within São Paulo municipality and its metropolitan area in Brazil. Feasibility assessments will be conducted at each site during an initial visit. Sites deemed suitable will then proceed with participant recruitment.

This study seeks to address critical aspects of managing IAD, particularly through innovative copper-based products. By focusing on clinical endpoints such as pain reduction, quality of life enhancements, and improvements in skin health, the trial aims to provide evidence supporting the potential benefits of copper-infused incontinence products over traditional alternatives.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Copper-based product; 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; 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.
Active Comparator: Control; Individuals enrolled in the treatment with common diapers plus usual care	Combination product: Barrier product with common diaper; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of non-progressing IAD 14 days	Proportion of non-progressing IAD after 14 days from randomization start by GLOBIAD criterion.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of non-progressing IAD 28 days	Proportion of non-progressing IAD after 28 days from randomization start by GLOBIAD criterion.	28 days
Pain assessment	Pain assessment using the numerical scale in 14 and 28 days; the scales goes from 0, for no pain, to 10, for the worst pain ever felt by the patient.	14 and 28 days
Quality of life SF12	Quality of life assessment in the 28th day (Short-Form 12 Health Survey). The maximum score is 100, and the higher the better.	28 days
Skin health by skin health assessment tool	The skin health of the subjects after 14 and 28 days using the skin health assessment tool, a visual assessment tool with no ordinal scale.	14 and 28 days
Time to resolution of IAD	Time to resolution of IAD	From enrollment to resolution, mean of 4 to 7 days
Reoccurrence of IAD	Reoccurrence of IAD during the follow-up of 28 days	From resolution of the first episode of IAD to the 28th day

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Essity Hygiene and Health AB
• Investigators: Principal Investigator: Henrique A Rodrigues da Fonseca, PhD, Hospital Israelita Albert Einstein - ARO

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: urinary incontinence; fecal incontinence; copper
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Fecal Incontinence; Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: COPPER_Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No