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NCT00643214 Clinical Trial

Evaluation of Tetrix Cream in the Healing of Injured Skin in Subjects With Contact Dermatitis

Healthy Clinical Trial

Official title:
A Study to Determine if Tetrix Cream Impedes the Resolution of Experimentally Induced Allergic Contact Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643214
Other study ID # 806 805 09 003
Secondary ID
Status Completed
Phase N/A
First received March 20, 2008
Last updated May 19, 2008
Start date October 2007
Est. completion date November 2007

Study information
Verified date May 2008
Source Coria Laboratories, Ltd.
Contact n/a
Is FDA regulated No
Health authority United 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, slows or interferes with the healing of the lesions.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Normal subjects with sensitivity to nickel.

Exclusion Criteria:

- Under 18 years of age.

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Tetrix
Twice daily topical application
• Tetrix
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 Clearing of signs and symptoms of contact dermatitis 10 days after induction of lesion and start of treatment Yes
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