An exploratory randomized, intra-individual controlled trialof the cutaneous healing properties of Petrolatum versus thevehicle for Oleogel-S10 versus no treatment when appliedtopically to mechanically induced partial thickness woundsin healthy volunteers

Amryt Research Ltd.0 个研究点目标入组 12 人开始时间: 2019年9月19日最近更新: 2020年7月20日

试验速览

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•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

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