EUCTR2020-002358-26-DE进行中（未招募）1 期
A randomised, intra-individual controlled trial of the cutaneous healing properties of petrolatum versus the vehicle for Oleogel-S10 when applied topically to mechanically induced partial thickness wounds in healthy volunteers
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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, vasectomy or vasectomised partner, sexual abstinence) during participation in the study (and for at least four weeks thereafter)
- •4. Skin phototype II to III according to the Fitzpatrick classification
- •5. Body mass index between 18.5 to 29.9 kg/m2 according to World Health Organization
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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