An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices

Launched by MOLNLYCKE HEALTH CARE AB · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well three different sticky devices, like special adhesive patches, stay attached to the skin. The goal is to compare two new devices to a standard one to see which sticks best. This study is being done with healthy volunteers who do not have any skin problems where the patches will be applied, usually on the back.

People eligible to join are adults in good general health with clean, healthy skin on their back and minimal hair there. They must be willing to follow study rules, like keeping the patch area dry, not using soaps, lotions, or sunscreens on the area before and during the study, and avoiding activities that might affect the patches. If you qualify and join, you can expect to have up to 12 small patches applied on your back, and you will attend several visits for the study team to check how well the patches stick and how your skin responds. Pregnant or breastfeeding individuals, those with allergies to adhesives, or certain health conditions would not be able to participate. This study is currently looking for volunteers to help with this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who are capable and willing to comply with protocol visits, assessments, and instructions.
• • Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).
• • Minimal hairiness at the back (location of the application sites).
• • Signed written informed consent.
• Exclusion Criteria:
• • Known allergy/hypersensitivity to the dressing or its components.
• • Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.
• • Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.
• • Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.
• • Participants not willing to avoid the use of leave on cosmetics such as creams/lotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.
• • Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.
• • Participants whose back is not large enough to accommodate all 12 application sites
• • Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.
• • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
• • Active skin disease at the application sites .
• • Any topical medication at the application sites within the last 24 hours prior to the start of the test and/or throughout the entire course of the investigation.
• • Pain relief medication on assessment visits . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as protocol deviation.
• • Pregnancy or lactation.
• • Drug addicts, alcoholics.
• • AIDS, HIV-positive or infectious hepatitis.
• • Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).
• • Participation in another investigative drug or device study currently or within the last 30 days.
• • Current participation in a cosmetic study.
• • Employees of the investigation sites directly involved in this clinical investigation.
• • Employees of the sponsor's company.
• • Employees of a competitor company. The participant should not work for any company which produces dressings.
• • The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason