Incontinence-associated DermatitisNCT06363786
Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters
A study testing Test patches in people with Incontinence-associated Dermatitis, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- Test patches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2024to 30 Aug 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Male and female ≥18 and ≤80 years.
- Willingness and ability to comply with study procedures, visit schedules, and requirements.
- Intact skin on the forearms without any signs of irritation.
- Agree not to shower or use cosmetic products on the arms the day before visit 1 and during the study period.
- Agree not to engage in intense physical activity throughout the study period.
Who cannot join
- Have any known allergies or intolerances to one or several components of the absorbing incontinence/menstrual products.
- Have any known allergies or intolerances to one or several ingredients in cosmetic products.
- Have an ongoing skin irritation/infection on the forearms.
- Have any skin conditions such as psoriasis and eczema.
- Have any tattoos on the forearms.
- Suffer from excessive sweating, hyperhidrosis.
Show all 12Show fewer
- Have immunodeficiency or any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Have an alcohol and/or drug dependency.
- Have had active sunbathing on arms latest 2 weeks prior to study.
- Have used tanning or bleaching products on arms at least 1 month before the study starts.
- Have performed hair removal on the arms 1 month prior to the study.
- Are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigating the Impact of Absorbent Products on Skin Occlusion: Changes to Skin Microbiome and Skin Parameters Due to Reduction of Skin Surface pH in Healthy Participants
The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and quantitative polymerase chain reaction (qPCR). In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of patches. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with appropriate statistical tests on 5% level for variables. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.
- Conditions
- Incontinence-associated Dermatitis
- Being tested
- Test patches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test patchesOther
Patches (incontinence product cut outs) with a low pH formula or control patches without formula.
| Study group | Role | What they receive |
|---|---|---|
| Test patches | Experimental | Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula. Receives: Other: Test patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin microbiome as measured by molecular sequencing
Molecular sequencing is used to provide taxonomic insight and overview of microbial diversity on the skin. Skin under the test and control patches are compared.
Measured: 2 days
Changes in skin microbiome diversity as measured by qPCR
qPCR is employed to analyse and quantify specific microbial species or groups. Skin under the test and control patches are compared.
Measured: 2 days
Skin surface pH
The change in skin surface pH under the test and control patches are compared.
Measured: 2 days
Secondary outcomes (4)
Change in Trans Epidermal Water loss
As measured by Dermalab instrument. Transepidermal water loss (TEWL) as measured under the test and control patches.
Measured: 2 days
Change in skin hydration
Skin hydration (SH) as measured with moisture meter instrument under the test and control patches.
Measured: 2 days
Change in Skin water profile
As measured Confocal raman microspectrometry. The water content of skin at different depths is measured and compared for the skin under test and control patches.
Measured: 2 days
Presence of low pH formula on the skin
The extent on formula transfer to the skin as measured with tape stripping.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start15 Apr 2024
- Primary completion30 May 2024
- Study completion30 Aug 2024
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameters and skin microbiome is measured on day 3.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrika Husmark, PhD, Principal investigator, Essity Hygiene and Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363786
- Sponsor's protocol ID
- GOOSEBERRY
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating the Impact of Absorbent Products on Skin Occlusion: Changes to Skin Microbiome and Skin Parameters Due to Reduction of Skin Surface pH in Healthy Participants
- ClinicalTrials.gov ID
- NCT06363786
- Acronym / sponsor ID
- GOOSEBERRY
- Conditions
- Incontinence-associated Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 12 Apr 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.
The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and quantitative polymerase chain reaction (qPCR). In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of patches. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with appropriate statistical tests on 5% level for variables. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameters and skin microbiome is measured on day 3.
| Arm | Type | Receives |
|---|---|---|
| Test patches | Experimental | Other: Test patchesApplication of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form
- Male and female ≥18 and ≤80 years.
- Willingness and ability to comply with study procedures, visit schedules, and requirements.
- Intact skin on the forearms without any signs of irritation.
- Agree not to shower or use cosmetic products on the arms the day before visit 1 and during the study period.
Key exclusion criteria (12 listed)
- Have any known allergies or intolerances to one or several components of the absorbing incontinence/menstrual products.
- Have any known allergies or intolerances to one or several ingredients in cosmetic products.
- Have an ongoing skin irritation/infection on the forearms.
- Have any skin conditions such as psoriasis and eczema.
- Have any tattoos on the forearms.
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 |
|---|---|---|
| Test patchesPatches (incontinence product cut outs) with a low pH formula or control patches without formula. | Other | Test patches |
Primary outcome
Changes in skin microbiome as measured by molecular sequencing
Time frame: 2 days
Molecular sequencing is used to provide taxonomic insight and overview of microbial diversity on the skin. Skin under the test and control patches are compared.
Changes in skin microbiome diversity as measured by qPCR
Time frame: 2 days
qPCR is employed to analyse and quantify specific microbial species or groups. Skin under the test and control patches are compared.
Skin surface pH
Time frame: 2 days
The change in skin surface pH under the test and control patches are compared.
4 secondary outcomes
Change in Trans Epidermal Water loss
Time frame: 2 days
Change in skin hydration
Time frame: 2 days
Change in Skin water profile
Time frame: 2 days
Presence of low pH formula on the skin
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Incontinence-associated Dermatitis
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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
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Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study
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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.
Ulrika Husmark, PhD principal investigator
Essity Hygiene and Health AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test patches in people with Incontinence-associated Dermatitis, run by Essity Hygiene and Health AB at 1 site in Sweden.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in skin microbiome as measured by molecular sequencing (time frame: 2 days). The study lists 3 primary outcomes in all. 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 3 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.