S50.81 T09.00
Conditions
Interventions
Group 1: Abrasive wound model, octenilin® wound gel, covered with standard of care plaster
Group 2: Abrasive wound model, untreated control, covered with standard of care plaster
Group 3: Abrasive wou
Sponsors
Schülke & Mayr GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained. 3. Healthy skin in the areas of the test fields (volar forearm and upper back). 4. The physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation. 5. Negative urine pregnancy test at Day 1 for all women of childbearing potential. 6. Female volunteers of childbearing potential must either be permanently sterile or agree to use an acceptable birth control method (failure rate of more than 1% per year, lower is also acceptable) from screening visit and 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 areas of the test fields (volar forearm and upper back). 2. Dark-skinned persons (Fitzpatrick skin types IV–VI). 3. Pregnancy or planned pregnancy or nursing. 4. 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. 5. 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. 6. Known hypersensitivity or known allergic reactions to components of the IMD , the foil, or adhesive on patches used for this clinical investigation. 7. 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, glucocorticosteroids, antibiotics, antiseptics, or antibacterial soaps) and during the conduct of this clinical investigation. 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 or other types of chronic eczema. 10. Contraindications according to the product brochure. 11. 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. 12. Close affiliation with the investigator (e.g., a close relative) or persons working at Eurofins bioskin GmbH/Eurofins bioskin RCD or participant is an employee of the sponsor. 13. Participants with a disposition to develop hypertrophic scarring, keloids, or wound healing disorders. 14. History of drug or alcohol abuse within the last year as per investigator assessment. 15. Participant is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint: • Comparison between IMD-treated and untreated test field regarding the mean AUCDays 2-16 values for re-epithelialization score separately for test fields covered with standard plaster and gauze. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoints: • Summary statistics for AUCDays 2-16 of re-epithelialization score by treatment (IMD and untreated) separately for test fields covered with standard plaster and gauze. • Frequency counts and summary statistics for re-epithelialization score by treatment and visit separately for test fields covered with standard plaster and gauze. • Frequency counts and summary statistics for scores on the 7-point crust formation scale by treatment and visit separately for test fields covered with standard plaster and gauze. Secondary endpoints: • Frequency counts and summary statistics for clinical assessment of local tolerability (erythema in close proximity to test fields with abraded skin) score by treatment (IMD and untreated) and visit separately for test fields covered with standard plaster and gauze - abrasive wound model. • Frequency counts and summary statistics for clinical assessment of local tolerability (erythema on scratched skin) score by treatment (IMD and untreated) and visit - modified scratch test. • CFU counts for skin surface microbes after occlusion of the test fields (upper back) for 24 hours | — |
Countries
Germany
Contacts
Public ContactPascal Bartling
Schülke & Mayr GmbH
Outcome results
None listed