NCT01227759

Tyrosur® Gel-Investigation on Wound Healing Efficacy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Engelhard Arzneimittel GmbH & Co.KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Wounds
• Wound Healing

Interventions

Type	Name	Description
DRUG	Drug containing the active ingredient	The topical application is performed once daily during a 12-day treatment.
DRUG	Placebo	Placebo containing no active ingredient

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-10-25
• Last updated: 2010-10-26