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
- Conditions
- Male or female subjects aged 18 years or older with healthy skin in the test area are eligible for this clinical trialMedDRA version: 12.1Level: LLTClassification code 10036892Term: Promotion of wound healing
- Registration Number
- EUCTR2010-020809-33-DE
- Lead Sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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
reactions;
• 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
consent;
• subject is institutionalized because of legal or regulatory order.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the improvement of wound healing in superficial wounds by Tyrosur Gel and its vehicle in comparison to an untreated test field.;Secondary Objective: ;Primary end point(s): Clinical assessment of the wound healing efficacy of Tyrosur® Gel (0.1 %) compared to untreated using a score for wound healing rates (AUC)
- Secondary Outcome Measures
Name Time Method