Not applicable, as healthy volunteers will be recruited, who will receive mechanically induced partial thickness wounds.
Conditions
Interventions
Product Name: Placebo of Oleogel-S10
Pharmaceutical Form: Gel
INN or Proposed INN: SUNFLOWER OIL, REFINED
Other descriptive name: SUNFLOWER OIL, REFINED
Concentration unit: mg/g milligram(s)/gram
Conc
Sponsors
Amryt Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe and to measure cutaneous healing of mechanically induced wounds with application of vehicle of Oleogel S10, petrolatum, and no treatment in healthy volunteers in a wound healing model of mechanically induced wounds.;Secondary Objective: To describe the safety, tolerability, and transepidermal water loss (TEWL) in healthy volunteers treated with the vehicle gel and petrolatum compared to no treatment in a wound healing model of mechanically induced wounds.;Primary end point(s): Because of the exploratory nature of the study, a distinction between primary and secondary endpoints will not be made. • Cutaneous wound healing: time to complete healing in days • Cutaneous wound healing: wound surface area per day in mm2 • Cutaneous wound healing: wound surface area per day according to clinical score • Transepidermal water loss per day in g/h/m2 • Adverse events;Timepoint(s) of evaluation of this end point: Cutaneous wound healing (Clinical observation by trained Investigator & Six-category clinical score): • Day 1 through Day 21 • Day 23 • Day 28 Cutaneous wound healing (Photo documentation with FotoFinder & Measurement of wound surface area using computerized image analysis (planimetry)): • Every 2 days (i.e., Day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and Day 23) • Day 28 Trans-epidermal water loss: • Every 2 days (i.e., Day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and Day 23) • Day 28 Local tolerance: At all visits Adverse events: At all visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see E.5.1;Timepoint(s) of evaluation of this end point: see E.5.1 | — |
Countries
Germany
Contacts
Public ContactHead of Clinical Development
Amryt Research Ltd.
Outcome results
None listed