Tyrosur® Gel-Investigation on Wound Healing Efficacy

Study Overview
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Brief Summary
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This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.

Detailed Description
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This is a single-center, randomized, observer-blind phase IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model. In the investigation two small, superficial, abrasive wounds will be induced on the right forearm and one on the left forearm of each subject using a sterile surgical hand brush. These wounds will then be treated with the investigational products. The wound healing will be clinically assessed and photographs will be taken for documentation.

Official Title
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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

Conditions
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Wounds, Wound Healing

Intervention / Treatment
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* Drug: Drug containing the active ingredient
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; Written informed consent obtained. 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; 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br> | Drug: Drug containing the active ingredient<br>* The topical application is performed once daily during a 12-day treatment.<br>* Other names: Tyrosur® Gel;|
| No Intervention: Untreated<br> | |
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br>* Placebo containing no active ingredient<br>* Other names: Vehicle to Tyrosur® Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of the wound healing efficacy of the vehicle compared to untreated using a score for wound healing rates; Photo documentation of the wound healing efficacy |  | 12 days |