Tyrosur® Gel-Investigation on Wound Healing Efficacy

Engelhard Arzneimittel

Status and phase

Completed

Phase 2

Conditions

Wound Healing

Wounds

Treatments

Drug: Drug containing the active ingredient

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227759

EA-10-1-042

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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;