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

This study has been completed.
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
First received: March 26, 2008
Last updated: May 19, 2008
Last verified: May 2008

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

Condition Intervention
Contact Dermatitis
Device: Tetrix
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis

Resource links provided by NLM:

Further study details as provided by Coria Laboratories, Ltd.:

Primary Outcome Measures:
  • Improvement in symptoms of burning and itching. [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Device: Tetrix
Twice daily topical application
Placebo Comparator: 2
Device: Placebo
Twice daily topical application


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Normal subjects with sensitivity to nickel
  2. Subjects with hand eczema

Exclusion Criteria:

under 18 years of age

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646867

United States, Kentucky
Dermatology Specialists, LLC
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Coria Laboratories, Ltd.
Principal Investigator: Joseph Fowler, MD Dermatology Specialists, LLC
  More Information

No publications provided

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00646867     History of Changes
Other Study ID Numbers: 805 806 09 004
Study First Received: March 26, 2008
Last Updated: May 19, 2008
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Coria Laboratories, Ltd.:
Tetrix cream, contact dermatitis, effect on burning and itching

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Irritant
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on April 17, 2014