Comparing how three adhesive dressings stay on the skin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adult volunteers will have three different adhesive dressings applied to defined sites on the back and monitored over the course of the visit schedule. The study compares two investigational devices to a reference test specimen for their wearing and self-adhesive properties. Investigators will confirm intact skin and minimal hair at application sites before enrollment and will monitor the sites for adhesion and any skin reactions. Participants must avoid wetting or applying detergents to the application sites for the study duration and return for protocol-specified assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• SGS proderm GmbH
  Schenefeld, Free and Hanseatic City of Hamburg, Germany Recruiting

Study contacts

• Principal investigator: Dr. Uta Solecke — SGS Proderm GmbH
• Study coordinator: Kristina Welinder
• Email: kristina.welinder@molnlycke.com
• Phone: +46 (0)31- 722 31 96

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pfizer medicine PF-08103402: how different doses are tolerated in healthy adults and adults with mild-to-moderate asthma

  This study tests how different amounts of PF-08103402 behave in the body and how well it is tolerated by healthy adults and adults with mild-to-moderate asthma.

  Recruiting at 2 sites Phase 1 Pfizer · New Haven, Connecticut and 1 other locations · NCT07660731

• Focal muscle vibration to limit leg muscle weakness during reduced use

  This trial will see if a 10-day program of focal muscle vibration can limit strength loss in healthy adults whose one leg is temporarily unloaded.

  Recruiting Centre Hospitalier Universitaire de Saint Etienne · Saint-Etienne · NCT07021079

• Kidney responses to exercise in heat and whether vitamin B3 changes them.

  This project will test whether taking vitamin B3 changes how the kidneys respond when healthy, physically fit adults exercise in hot, humid conditions.

  Recruiting at 2 sites Early Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts and 1 other locations · NCT06983730

• Assessing the safety of inhaling xenon gas in healthy volunteers

  This study is testing if inhaling xenon gas is safe for healthy people to see if it could help in treating neurodegenerative diseases like Alzheimer's in the future.

  Recruiting Phase 1 General Biophysics LLC · Boston, Massachusetts · NCT06945614

• Brain responses to gentle ear stimulation measured with near-infrared light

  This one-visit test uses gentle ear stimulation and near-infrared head sensors to see how healthy adults' brains respond.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06825364

• A program combining music and activities to promote healthy aging

  This study is testing whether a program that combines music, exercise, and social activities can help older adults keep their minds sharp and improve their overall brain health.

  Recruiting at 4 sites University of Bari · Adelfia, Bari and 3 other locations · NCT06767410

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.