Not applicable, as healthy volunteers will be recruited, who will receive mechanically induced partial thickness wounds.
Conditions
Interventions
Trade Name: ALLERGIKA® – BASISSALBE
Pharmaceutical Form: Ointment
INN or Proposed INN: LIQUID PARAFFIN PH. EUR
Other descriptive name: LIQUID PARAFFIN PH. EUR
Concentration unit: mg/g milligram(s)/gra
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. SARS-CoV-2 infection is confirmed 3. Positive human immunodeficiency virus, hepatitis B or C serology 4. Known or suspected defect of wound healing 5. Any kind of systemic skin barrier impairment, e.g. atopic dermatitis, psoriasis 6. Scars, tattoos or other skin signs interfering with the study procedures and measurements 7. Sunburn 8. Ultraviolet sessions or sun exposure of the arms planned during the study period 9. Known or suspected hypersensitivity to one of the components of the investigational medicinal products 10. Allergy to Mepilex® Border Lite dressing 11. Any treatment which may affect the blood coagulation and haemostasis (anticoagulant medications, non steroidal anti inflammatory drugs, etc.) 12. Any physical treatment (like laser or surgery) on the arms within the last six months 13. Use of topical or systemic treatments on the investigational areas within four weeks of Day 1 (including but not limited to: topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C) that would interfere with assessment and/or investigational treatments 14. Systemic antibiotics, systemic or topical steroids within two weeks of Day 1 15. History or presence of alcohol or drug abuse within the last two years 16. Medical history of skin cancer 17. Diabetes mellitus 18. Any acute or unstable chronic pathology that may interfere with the study conduct, in the opinion of the investigator including found or suspected active SARS-CoV-2 infection 19. Current participation or participation in a clinical study within 30 days of Day 1 20. Subject is in a dependent relationship (e.g. relative or family member) with the investigator, study site’s staff, or sponsor’s staff 21. Subjects who have been placed in an institution through an official or court order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the vehicle for Oleogel-S10 is non-inferior to petrolatum with regards to time to achieve cutaneous healing of mechanically induced partial thickness wounds in healthy volunteers;Secondary Objective: To evaluate - change in cutaneous healing per day of mechanically induced wounds following application of vehicle for Oleogel-S10 and petrolatum - safety and tolerability of vehicle for Oleogel-S10 and petrolatum as assessed by the incidence, severity, and relatedness of adverse events (AEs) in healthy volunteers with mechanically induced wounds ;Primary end point(s): Days until complete healing of mechanically induced wounds in terms of complete re-epithelialisation (assessed by clinical score);Timepoint(s) of evaluation of this end point: Day 1 to Day 16 and Day 23 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - days until complete healing of mechanically induced wounds according to planimetry - clinical score per day - wound surface area in mm2 per day according to planimetry - incidence, severity, and causality of local AEs - incidence, severity, and causality of all AEs;Timepoint(s) of evaluation of this end point: - days until complete healing of mechanically induced wounds according to planimetry: Day 1, Day 3 and Day 5 to Day 16 - clinical score per day: Day 1 to Day 16 and Day 23 - wound surface area in mm2 per day according to planimetry: Day 1, Day 3 and Day 5 to Day 16 - incidence, severity, and causality of local AEs: Day 1 to Day 23 - incidence, severity, and causality of all AEs: Day -14 to Day 23 | — |
Countries
Germany
Contacts
Public ContactHead of Clinical Development
Amryt Research Ltd.
Outcome results
None listed