Male or female subjects aged 18 years or older with healthy skin in the test area are eligible for this clinical trial MedDRA version: 12.1 Level: LLT Classification code 10036892 Term: Promotion of wound healing
Conditions
Interventions
Trade Name: Tyrosur Gel (0.1%)
Pharmaceutical Form: Gel
CAS Number: 1404-88-2
Other descriptive name: TYROTHRICIN
Concentration unit: % percent
Concentration type: equal
Concentration number: -0.1
Pha
Sponsors
Engelhard Arzneimittel GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Outcome results
None listed