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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental |
| |
| Untreated | No Intervention | ||
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug containing the active ingredient | Drug | The topical application is performed once daily during a 12-day treatment. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Wigger-Alberti, MD | Managing director bioskin, Hamburg Germany | Principal Investigator |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Placebo | Drug | Placebo containing no active ingredient |
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