Tyrosur® Gel-Investigation on Wound Healing Efficacy

This study has been completed.
Sponsor:
Information provided by:
Engelhard Arzneimittel GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01227759
First received: October 22, 2010
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Wounds
Wound Healing
Drug: Drug containing the active ingredient
Drug: Placebo
Phase 2

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

Further study details as provided by Engelhard Arzneimittel GmbH & Co.KG:

Primary Outcome Measures:
  • Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates [ Time Frame: 12 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum Drug: Drug containing the active ingredient
The topical application is performed once daily during a 12-day treatment.
Other Name: Tyrosur® Gel
No Intervention: Untreated
Placebo Comparator: Vehicle Drug: Placebo
Placebo containing no active ingredient
Other Name: Vehicle to Tyrosur® Gel

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227759

Sponsors and Collaborators
Engelhard Arzneimittel GmbH & Co.KG
Investigators
Principal Investigator: Walter Wigger-Alberti, MD Managing director bioskin, Hamburg Germany
  More Information

No publications provided

Responsible Party: W. Wigger-Alberti, M.D., bioskin GmbH
ClinicalTrials.gov Identifier: NCT01227759     History of Changes
Other Study ID Numbers: EA-10-1-042
Study First Received: October 22, 2010
Last Updated: October 25, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tyrothricin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on April 17, 2014