Assessment of wound healing efficacy and local tolerability of a wound gel with intraindividual comparison using an abrasive wound model in a single-center, randomized, investigator-blind clinical investigation - EA-19-02-083

Engelhard Arzneimittel GmbH & Co. KG0 个研究点目标入组 33 人开始时间: 2020年2月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Healthy skin on the volar forearms;
•2. Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner;
•3. Urine pregnancy test negative for all females;
•4. Written informed consent obtained.

•1. Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper- or hypopigmentation or tattoos in the test fields;
•2. Dark-skinned persons (Fitzpatrick skin types IV–VI);
•3. Symptoms of a clinically significant illness that may influence the outcome of the investigation in the 4 weeks before baseline and during the clinical investigation;
•4. Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit of this clinical investigation and during the conduct of this investigation;
•5. Known hypersensitivity or known allergic reactions to components of the MD or the protective standard wound plaster used;
•6. Subjects with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus, impaired wound healing or keloid development;
•7. Contraindications according to the package leaflet/instructions of use (Hansaplast Sensitive);

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