S50.81
Conditions
Interventions
Group 1: Wound model for skin abrasion, Hydrocolloid Plaster
Group 2: Wound model for skin abrasion, Polyurethane (PU) Plaster
Group 3: Wound model for skin abrasion, Standard dressing
Group 4: Wound
Sponsors
Beiersdorf AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained. 3 Fitzpatrick skin types I–III. 4. The physical examination of the skin in the test area (volar forearms) must be healthy and without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation. 5. Negative urine pregnancy test for women of childbearing potential. 6. Female volunteers of childbearing potential must either be permanently sterile or agree to use a highly effective birth control method (failure rate of < 1% per year) (Clinical Trials Coordination Group [CTCG], 2024) throughout the clinical investigation.
Exclusion criteria
Exclusion criteria: 1. Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper- or hypopigmentation or tattoos in the test fields. 2. Pregnancy or planned pregnancy or nursing. 3. Symptoms of a clinically significant illness that may influence the outcome of the clinical investigation in the 4 weeks before baseline and during the clinical investigation. 4. Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit (Day 1) of this clinical investigation and during the conduct of this clinical investigation. 5. Known hypersensitivity or known allergic reactions to components of the IMDs, to adhesive tapes or rubber latex. 6. Treatment with systemic medications or medications acting locally in the test field areas which might counter or influence the clinical investigation aim within 2 weeks before the baseline visit (Day 1) (e.g., antihistamines or glucocorticosteroids) and during the conduct of this clinical investigation. 7. Treatment with pain relievers such as Paracetamol, Ibuprofen, etc. on Days 1 and 2. 8. Participants who have taken any anticoagulant medication within 3 weeks prior to Day 1, or with a history of hemophilia or any other illness influencing the participant’s coagulation system. 9. Participants with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus. 10. Participant with a disposition to develop hypertrophic scarring, keloids, or wound healing disorders. 11. Evidence of drug or alcohol abuse. 12. Contraindications according to the investigator’s brochures (IBs)/instructions for use (IFUs). 13. If in the opinion of the investigator or physician performing the initial examination the participant should not participate in the clinical investigation, e.g., due to probable noncompliance or inability to understand the clinical investigation and adequately given informed consent. 14. Close affiliation with the investigator (e.g., a close relative) or persons working at Eurofins bioskin GmbH or participant is an employee of the sponsor. 15. Participant is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint: Comparisons between treatments regarding the mean AUC[Days1-24] values for re-epithelialization score: - each Treatment 1 and 2 vs. each Treatment 3 and 4 Differences in mean AUC[Days1-24] between treatments will be presented as shift in progression of wound re-epithelialization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoints: - Comparisons between treatments regarding the mean AUC[Days1-24] values for global assessment (by blinded investigator and participant) of wound healing performance analogously to primary endpoint. - Summary statistics for AUC[Days1-24] of re-epithelialization and global assessment (by blinded investigator and participant) of wound healing performance scores by treatment. - Frequency counts and summary statistics for re-epithelialization and global assessment (by blinded investigator and participant) of wound healing performance scores by treatment and visit. - Frequency counts for time until 100% healing and until at least 75% healing by treatment. - Frequency counts and summary statistics for scores on the 7-point crust formation scale by treatment and visit. - Frequency counts and summary statistics for clinical assessment of local tolerability by blinded investigator by treatment and visit. - Frequency counts and summary statistics for global assessment (by blinded investigator and participant) of tolerability by treatment and visit. - Summary statistics for sum scores for clinical assessment of tolerability by blinded investigator and global assessment (by blinded investigator and participant) of local tolerability over all visits by treatment. - Frequency counts for signs of infection by treatment and visit. | — |
Countries
Germany
Outcome results
None listed