How dressings change skin pH in simulated skin folds

Influence of Dressings on Skin pH Alterations in Simulated Skin Folds in Healthy Subjects

This will test different dressings on healthy adults to see if they change skin pH when covered to mimic a skin fold for about 24 hours.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Essity Hygiene and Health AB (Industry-sponsored)
• Locations: 1 site (Mölndal)
• Trial ID: NCT07547488 on ClinicalTrials.gov

What this trial studies

Healthy volunteers will have dressings applied to a marked area on the forearm, covered with a non-breathable film to create an occlusive, skin-fold-like environment for roughly 24 hours. Skin pH will be measured at the same forearm site before dressing application and again after the wear period during two separate visits. The study compares the pH effects of various dressing materials under controlled occlusion in participants without skin disease. Results will show how different dressings influence local skin acidity under simulated skin fold conditions.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18–80 with intact forearm skin who can avoid showering, cosmetic products, and intense exercise during the study period.

Not a fit: People with any skin disorder, known adhesive or component allergies, tattoos on the forearms, current antibiotic use, excessive sweating, or who are pregnant or breastfeeding would not be expected to benefit or be eligible.

Why it matters

Potential benefit: If successful, the findings could help clinicians and manufacturers choose or design dressings that limit harmful skin pH changes and reduce irritation in skin folds.

How similar studies have performed: Prior laboratory and small clinical studies have shown that occlusion and some dressing materials can alter skin pH, so this work builds on existing, but not definitive, evidence.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent to participate in this study
2. Healthy men and women between 18-80 years
3. Patient is mentally and physically able to participate in this study
4. Intact skin on the forearms without any signs of irritation
5. Agreed on not to shower or use cosmetic products on the arms the same day as visit 1 and during the study period
6. Agreed not to engage in intense physical activity throughout the study period

Exclusion Criteria:

1. Skin disorder of any kind.
2. Known allergy to adhesives or/and any other component(silver) in the investigation devices.
3. Pregnant or lactating women.
4. Presence of tattoos on the forearms.
5. Ongoing medication with antibiotic.
6. Suffer from excessive sweating, hyperhidrosis.

Where this trial is running

Mölndal

• Essity Study site — Mölndal, Sweden (Recruiting)

Study contacts

• Study coordinator: Fana Hunegnaw

Conditions Skin Folds