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NCT00646867 Clinical Trial

Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis

Contact Dermatitis Clinical Trial

Official title:
An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00646867
Other study ID # 805 806 09 004
Secondary ID
Status Completed
Phase N/A
First received March 26, 2008
Last updated May 19, 2008
Start date February 2008
Est. completion date March 2008

Study information
Verified date May 2008
Source Coria Laboratories, Ltd.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date March 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Normal subjects with sensitivity to nickel

2. Subjects with hand eczema

Exclusion Criteria:

under 18 years of age

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Tetrix
Twice daily topical application
• Placebo
Twice daily topical application

Locations
Country Name City State
United States Dermatology Specialists, LLC Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Coria Laboratories, Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in symptoms of burning and itching. after 14 days of treatment Yes
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