Tyrosur® Gel-Investigation on Wound Healing Efficacy

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Engelhard Arzneimittel GmbH & Co.KG
• Treatments: Tyrothricin

Criteria

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;