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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing; Wounds
• Intervention / Treatment: Drug: Drug containing the active ingredient; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Engelhard Arzneimittel GmbH & Co.KG
• Investigators: Principal Investigator: Walter Wigger-Alberti, MD, Managing director bioskin, Hamburg Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 26, 2010
• Last Update Submitted That Met QC Criteria: October 25, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Tyrothricin
• Other Study ID Numbers: EA-10-1-042