A clinical trial to assess the effect of Petrolatum, thevehicle for Oleogel-S10 or, respectively, no treatment on the skin healing process of healthy volunteers with superficial skin wounds.
- Conditions
- ot applicable, as healthy volunteers will be recruited, who will receive mechanically induced partial thickness wounds.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-002081-12-DE
- Lead Sponsor
- Amryt Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
1. Adult healthy volunteers aged 18 to 45 years
2. Male or female
3. Sexually active females of childbearing potential must be willing to use an effective form of birth control with failure rates <1% per year (e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomy or vasectomised partner) during participation in the study (and at least 4 weeks thereafter)
4. Skin type II to III according to the Fitzpatrick classification (Fitzpatrick 1988)
5. BMI between 18.5 to 29.99 kg/m2 according to WHO
6. Non-smoker
7. Subject has been informed, has read and understood the information/informed consent form, and has given written informed consent
8. Subject must be able and willing to follow study procedures and instructions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Pregnant or nursing women
2. Positive HIV, hepatitis B or C serology
3. Known or suspected defect of wound healing
4. Any kind of systemic skin barrier impairment, e.g. atopic dermatitis, psoriasis
5. Scars, tattoos or other skin signs interfering with the study procedures and measurements
6. Sunburn
7. UV sessions or sun exposure of the arms planned during the study period
8. Known or suspected hypersensitivity to one of the components of the investigational medicinal products
9. Allergy to Mepilex® dressing
10. Any treatment which may affect the blood coagulation and haemostasis (anticoagulant medications, NSAID, etc.)
11. Any physical treatment (like laser or surgery) on the arms within the last 6 months
12. Use of topical or systemic treatments on the investigational areas within the 4 past weeks (including but not limited to: topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C) that would interfere with assessment and/or investigational treatments
13. Systemic antibiotics, systemic or topical steroids within 2 weeks of Day 1
14. History or presence of alcohol or drug abuse within the last 2 years
15. Medical history of skin cancer
16. Diabetes mellitus
17. Any acute or unstable chronic pathology that may interfere with the study conduct, in the opinion of the Investigator
18. Current participation or participation in a clinical study within 30 days of Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method