Tyrosur® Gel-Investigation on Wound Healing Efficacy
|Wounds Wound Healing||Drug: Drug containing the active ingredient Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates [ Time Frame: 12 days ]
- 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 [ Time Frame: 12 days ]
|Study Start Date:||September 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: Drug containing the active ingredient
The topical application is performed once daily during a 12-day treatment.
Other Name: Tyrosur® Gel
|No Intervention: Untreated|
|Placebo Comparator: Vehicle||
Placebo containing no active ingredient
Other Name: Vehicle to Tyrosur® Gel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227759
|Principal Investigator:||Walter Wigger-Alberti, MD||Managing director bioskin, Hamburg Germany|