Tyrosur® Gel-Investigation on Wound Healing Efficacy

NCT ID: NCT01227759

Last Updated: 2010-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-10-31

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.

Conditions

Wounds; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Verum

Group Type: EXPERIMENTAL

Drug containing the active ingredient

Intervention Type: DRUG

The topical application is performed once daily during a 12-day treatment.

Untreated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vehicle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo containing no active ingredient

Interventions

Drug containing the active ingredient

The topical application is performed once daily during a 12-day treatment.

Intervention Type: DRUG

Placebo

Placebo containing no active ingredient

Intervention Type: DRUG

Other Intervention Names

Tyrosur® Gel; Vehicle to Tyrosur® Gel

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Engelhard Arzneimittel GmbH & Co.KG

INDUSTRY

Sponsor Role: lead

Responsible Party

bioskin GmbH

Principal Investigators

Walter Wigger-Alberti, MD

Role: PRINCIPAL_INVESTIGATOR

Managing director bioskin, Hamburg Germany

Other Identifiers

EA-10-1-042

Identifier Type: -

Identifier Source: org_study_id