Tyrosur® Gel-Investigation on Wound Healing Efficacy

Wounds Clinical Trial

Official title:

A Phase IIa, Single-center, Randomized, Observer-blind Trial With Intraindividual Comparison of Treated Versus Untreated to Assess the Wound Healing Efficacy of Topical Tyrosur® Gel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227759
• Other study ID #: EA-10-1-042
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2010
• Last updated: October 25, 2010
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Engelhard Arzneimittel GmbH & Co.KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing
• Wounds

Intervention

Drug:
• Drug containing the active ingredient
The topical application is performed once daily during a 12-day treatment.
• Placebo
Placebo containing no active ingredient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Engelhard Arzneimittel GmbH & Co.KG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates		12 days	No
Secondary	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	No