Back to resultsTyrosur® Gel-Investigation on Wound Healing Efficacy
Primary Purpose
Wounds, Wound Healing
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Drug containing the active ingredient
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wounds
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Placebo Comparator
Arm Label
Verum
Untreated
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01227759
First Posted
October 22, 2010
Last Updated
October 25, 2010
Sponsor
Engelhard Arzneimittel GmbH & Co.KG
1. Study Identification
Unique Protocol Identification Number
NCT01227759
Brief Title
Tyrosur® Gel-Investigation on Wound Healing Efficacy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Engelhard Arzneimittel GmbH & Co.KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum
Arm Type
Experimental
Arm Title
Untreated
Arm Type
No Intervention
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Drug containing the active ingredient
Other Intervention Name(s)
Tyrosur® Gel
Intervention Description
The topical application is performed once daily during a 12-day treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle to Tyrosur® Gel
Intervention Description
Placebo containing no active ingredient
Primary Outcome Measure Information:
Title
Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates
Time Frame
12 days
Secondary Outcome Measure Information:
Title
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
Time Frame
12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Wigger-Alberti, MD
Organizational Affiliation
Managing director bioskin, Hamburg Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Tyrosur® Gel-Investigation on Wound Healing Efficacy
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