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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01227759
Other study ID # EA-10-1-042
Secondary ID
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


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
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