Tyrosur® Gel-Investigation on Wound Healing Efficacy

NCT01227759 | Completed Phase 2 DMC

• 1 other identifier: EA-10-1-042
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wounds; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of the wound healing efficacy of verum compared to untreated using a score for wound healing rates

  12 days

Secondary Outcomes (1)

• 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

Study Arms (3)

Verum

EXPERIMENTAL

Drug: Drug containing the active ingredient

Untreated

NO INTERVENTION

Vehicle

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Drug containing the active ingredient DRUG

The topical application is performed once daily during a 12-day treatment.

Also known as: Tyrosur® Gel

Verum

Placebo DRUG

Placebo containing no active ingredient

Also known as: Vehicle to Tyrosur® Gel

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Engelhard Arzneimittel GmbH & Co.KG: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Walter Wigger-Alberti, MD

  Managing director bioskin, Hamburg Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10