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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646867
First Posted: March 31, 2008
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Coria Laboratories, Ltd.
  Purpose
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 (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 ]

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
Experimental
Device: Tetrix
Twice daily topical application
Placebo Comparator: 2
Placebo
Device: Placebo
Twice daily topical application

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

under 18 years of age

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646867


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

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00646867     History of Changes
Other Study ID Numbers: 805 806 09 004
First Submitted: March 26, 2008
First Posted: March 31, 2008
Last Update Posted: May 22, 2008
Last Verified: May 2008

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

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