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NCT Number: NCT07547488

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

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Dressings

Device

Sorbact® Ribbon, Sorbact® Compress and InterDry®

Primary outcomes

  1. 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

Secondary outcomes

  1. Difference in skin pH

    Time frame: 24 hour of wear time

    Difference in skin pH between the simulated skin fold and the area under Sorbact® Compress,

  2. Difference in skin pH

    Time frame: 24 hours of wear time

    Difference in skin pH between the simulated skin fold and the area under InterDry®,

  3. Change in skin hydration under occlusion from baseline

    Time frame: 24 hours of wear time

    Change in skin hydration from baseline to after wear time, measured in the simulated skinfold under occlusion using a moisture meter

Other outcomes

  1. Differences in skin pH between the different dressings

    Time frame: 24 hours of wear time

    Differences in skin pH measured under Sorbact® Ribbon, Sorbact® Compress and InterDry®.

Study contacts

Contact information is provided by the study sponsor or research team.

Fana Hunegnaw

CONTACT

[email protected]

+46761361512

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Acronym: pHase

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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