Status:
COMPLETED
Tyrosur® Gel-Investigation on Wound Healing Efficacy
Lead Sponsor:
Engelhard Arzneimittel GmbH & Co.KG
Conditions:
Wounds
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 healin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01227759
Start Date
September 1 2010
End Date
October 1 2010
Last Update
October 26 2010
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