Skin FoldspHaseNCT07547488
Influence of Dressings on Skin pH Alterations in Simulated Skin Folds in Healthy Subjects
A study testing Dressings in people with Skin Folds, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Folds
- What is being tested?
- Dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 5 Nov 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Written informed consent to participate in this study
- Healthy men and women between 18-80 years
- Patient is mentally and physically able to participate in this study
- Intact skin on the forearms without any signs of irritation
- Agreed on not to shower or use cosmetic products on the arms the same day as visit 1 and during the study period
- Agreed not to engage in intense physical activity throughout the study period
Who cannot join
- Skin disorder of any kind.
- Known allergy to adhesives or/and any other component(silver) in the investigation devices.
- Pregnant or lactating women.
- Presence of tattoos on the forearms.
- Ongoing medication with antibiotic.
- Suffer from excessive sweating, hyperhidrosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Essity Study site
Mölndal
Fredrik Agholme, +46730323634, fredrik.agholme@essity.com
About this study
This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment.
Read the detailed description
This study evaluates the impact of various dressings on skin pH when applied to a simulated skin fold environment. To replicate the occlusive conditions commonly found in skin folds, a non-breathable film will be placed over the dressings, maintaining occlusion for approximately 24 hours.
Skin pH measurements will be taken during two separate visits: once before dressing application and again after approximately 24 hours of wear time. Both measurements will be conducted on the same location on the forearms of healthy participants. The goal is to investigate how different dressings influence skin pH under occlusive conditions.
- Conditions
- Skin Folds
- Being tested
- Dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DressingsDevice
Sorbact® Ribbon, Sorbact® Compress and InterDry®
| Study group | Role | What they receive |
|---|---|---|
| Dressings | Experimental | Every participant will use all different dressing used in the trial. Receives: Device: Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in skin pH
Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress, measured after approximately 24 hours of wear time
Measured: 24 hours of wear time
Secondary outcomes (3)
Difference in skin pH
Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress,
Measured: 24 hour of wear time
Difference in skin pH
Difference in skin pH between the simulated skin fold and the area under InterDry®,
Measured: 24 hours of wear time
Change in skin hydration under occlusion from baseline
Change in skin hydration from baseline to after wear time, measured in the simulated skinfold under occlusion using a moisture meter
Measured: 24 hours of wear time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start5 Nov 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin FoldsStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547488
- Sponsor's protocol ID
- pHase
- Acronym
- pHase
- Status last verified
- Oct 2025
- First submitted
- 23 Mar 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dressings on Skin pH Alterations in Simulated Skin Folds in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07547488
- Acronym / sponsor ID
- pHase / pHase
- Conditions
- Skin Folds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment.
Detailed description
This study evaluates the impact of various dressings on skin pH when applied to a simulated skin fold environment. To replicate the occlusive conditions commonly found in skin folds, a non-breathable film will be placed over the dressings, maintaining occlusion for approximately 24 hours.
Skin pH measurements will be taken during two separate visits: once before dressing application and again after approximately 24 hours of wear time. Both measurements will be conducted on the same location on the forearms of healthy participants. The goal is to investigate how different dressings influence skin pH under occlusive conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dressings | Experimental | Device: DressingsEvery participant will use all different dressing used in the trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to participate in this study
- Healthy men and women between 18-80 years
- Patient is mentally and physically able to participate in this study
- Intact skin on the forearms without any signs of irritation
- Agreed on not to shower or use cosmetic products on the arms the same day as visit 1 and during the study period
Key exclusion criteria (6 listed)
- Skin disorder of any kind.
- Known allergy to adhesives or/and any other component(silver) in the investigation devices.
- Pregnant or lactating women.
- Presence of tattoos on the forearms.
- Ongoing medication with antibiotic.
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 |
|---|---|---|
| DressingsSorbact® Ribbon, Sorbact® Compress and InterDry® | Device | Dressings |
Primary outcome
Difference in skin pH
Time frame: 24 hours of wear time
Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress, measured after approximately 24 hours of wear time
3 secondary outcomes
Difference in skin pH
Time frame: 24 hour of wear time
Difference in skin pH
Time frame: 24 hours of wear time
Change in skin hydration under occlusion from baseline
Time frame: 24 hours of wear time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressings in people with Skin Folds, 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 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fana Hunegnaw (+46761361512, fana.hunegnaw@essity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in skin pH (time frame: 24 hours of wear time). 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 23 Apr 2026.