Tyrosur® Gel-Investigation on Wound Healing Efficacy

Phase 2

Completed

• Conditions: Wounds; Wound Healing
• Interventions: Drug: Drug containing the active ingredient; Drug: Placebo

• Registration Number: NCT01227759
• Lead Sponsor: Engelhard Arzneimittel GmbH & Co.KG

Brief 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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Verum	Drug containing the active ingredient	-
Vehicle	Placebo	-

Primary Outcome Measures

Name	Time	Method
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates	12 days

Secondary Outcome Measures

Name	Time	Method
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