Incontinence-associated DermatitisPhase 2/3NCT06726707
COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis
A Phase 2/3 study testing Barrier product with common diaper in people with Incontinence-associated Dermatitis, run by Hospital Israelita Albert Einstein.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- Barrier product with common diaper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Aug 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Incontinence-associated Dermatitis
- Being tested
- Diaper with a copper-based product + usual care, Barrier product with common diaper
- Keywords
- urinary incontinence, fecal incontinence, copper
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaper with a copper-based product + usual careCombination 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.
Barrier product with common diaperCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Copper-based product | Experimental | Individuals enrolled in the treatment with diapers embedded with a copper-based product plus usual care Receives: Combination Product: Diaper with a copper-based product + usual care |
| Control | Active comparator | Individuals enrolled in the treatment with common diapers plus usual care Receives: Combination Product: Barrier product with common diaper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of non-progressing IAD 14 days
Proportion of non-progressing IAD after 14 days from randomization start by GLOBIAD criterion.
Measured: 14 days
Secondary outcomes (6)
Proportion of non-progressing IAD 28 days
Proportion of non-progressing IAD after 28 days from randomization start by GLOBIAD criterion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 and 28 days
Time to resolution of IAD
Time to resolution of IAD
Measured: From enrollment to resolution, mean of 4 to 7 days
Reoccurrence of IAD
Reoccurrence of IAD during the follow-up of 28 days
Measured: From resolution of the first episode of IAD to the 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Why it stopped: At the discretion of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Essity Hygiene and Health AB
- Responsible party
- Sponsor
- Investigators
- Henrique A Rodrigues da Fonseca, PhD, Principal investigator, Hospital Israelita Albert Einstein - ARO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726707
- Sponsor's protocol ID
- COPPER_Trial
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPPER: An Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory Trial, Evaluating the Management of Incontinence-Associated Dermatitis Using Copper Containing Absorbing Incontinence Products
- ClinicalTrials.gov ID
- NCT06726707
- Acronym / sponsor ID
- COPPER_Trial
- Conditions
- Incontinence-associated Dermatitis
- Keywords
- urinary incontinence, fecal incontinence, copper
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At the discretion of the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Essity Hygiene and Health AB
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory trial
| Arm | Type | Receives |
|---|---|---|
| Copper-based product | Experimental | Combination Product: Diaper with a copper-based product + usual careIndividuals enrolled in the treatment with diapers embedded with a copper-based product plus usual care |
| Control | Active comparator | Combination Product: Barrier product with common diaperIndividuals enrolled in the treatment with common diapers plus usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaper with a copper-based product + usual careThe 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. | Combination product | Copper-based product |
| Barrier product with common diaperThe 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. | Combination product | Control |
Primary outcome
Proportion of non-progressing IAD 14 days
Time frame: 14 days
Proportion of non-progressing IAD after 14 days from randomization start by GLOBIAD criterion.
6 secondary outcomes
Proportion of non-progressing IAD 28 days
Time frame: 28 days
Pain assessment
Time frame: 14 and 28 days
Quality of life SF12
Time frame: 28 days
Skin health by skin health assessment tool
Time frame: 14 and 28 days
Time to resolution of IAD
Time frame: From enrollment to resolution, mean of 4 to 7 days
Reoccurrence of IAD
Time frame: From resolution of the first episode of IAD to the 28th day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Incontinence-associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
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Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study
Incontinence-associated Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrique A Rodrigues da Fonseca, PhD principal investigator
Hospital Israelita Albert Einstein - ARO
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Barrier product with common diaper in people with Incontinence-associated Dermatitis, run by Hospital Israelita Albert Einstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of non-progressing IAD 14 days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.