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

This study investigates the effect of different dressings on skin pH when applied to a simulated skin fold environment.

Study Overview

• Status: Recruiting
• Conditions: Skin Folds
• Intervention / Treatment: Device: Dressings

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fana Hunegnaw; Phone Number: +46761361512; Email: fana.hunegnaw@essity.com

Study Locations

• Sweden
  • Mölndal, Sweden
    • Recruiting
    • Essity Study site
    • Contact: Fredrik Agholme; Phone Number: +46730323634; Email: fredrik.agholme@essity.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dressings; Every participant will use all different dressing used in the trial.	Device: Dressings; Sorbact® Ribbon, Sorbact® Compress and InterDry®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours of wear time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in skin pH	Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress,	24 hour of wear time
Difference in skin pH	Difference in skin pH between the simulated skin fold and the area under InterDry®,	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	24 hours of wear time

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in skin pH between the different dressings	Differences in skin pH measured under Sorbact® Ribbon, Sorbact® Compress and InterDry®.	24 hours of wear time

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Bandages
• Other Study ID Numbers: pHase

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