A phase IIa, single-center, randomized, observer-blind trial with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of topical Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model

Engelhard Arzneimittel GmbH & Co.KG0 个研究点开始时间: 2010年8月3日最近更新: 2013年3月11日

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•men and women aged 18 years or older with healthy skin in the test area;
•the physical examination must be without disease findings unless the investigator
•considers an abnormality to be irrelevant for the outcome of the clinical trial;
•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;
•written informed consent obtained.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
•dark-skinned persons whose skin color prevents ready assessment of skin
•subjects with diabetes, psoriasis or lichen ruber planus;
•history of wound-healing complications, or keloid and hypertrophic scarring;
•evidence of drug or alcohol abuse;
•pregnancy or nursing;
•symptoms of a clinically significant illness that may influence the outcome of the
•trial in the four weeks before and during the trial;
•participation in the treatment phase of another clinical trial within the last four
•weeks prior to the first administration of investigational drug in this clinical trial;
•known allergic reactions to components of the investigational product/s;
•treatment with systemic or locally acting medications which might counter or
•influence the trial aim within two weeks before the baseline visit (e.g.
•antihistamines or glucocorticosteroids);
•contraindications according to summary of product characteristics;
•in the opinion of the investigator or physician performing the initial examination the
•subject should not participate in the clinical trial, e.g. due to probable
•noncompliance or inability to understand the trial and give adequately informed
•subject is institutionalized because of legal or regulatory order.

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