Overview

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;