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

This study has been completed.
Sponsor:
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00646867
First received: March 26, 2008
Last updated: May 19, 2008
Last verified: May 2008
  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 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
Experimental
Device: Tetrix
Twice daily topical application
Placebo Comparator: 2
Placebo
Device: Placebo
Twice daily topical application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Dermatitis, Contact
Dermatitis, Irritant
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on September 11, 2014