Back to resultsEffect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
Primary Purpose
Contact Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetrix
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Contact Dermatitis focused on measuring Tetrix cream, contact dermatitis, effect on burning and itching
Eligibility Criteria
Inclusion Criteria:
- Normal subjects with sensitivity to nickel
- Subjects with hand eczema
Exclusion Criteria:
under 18 years of age
Sites / Locations
- Dermatology Specialists, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Experimental
Placebo
Outcomes
Primary Outcome Measures
Improvement in symptoms of burning and itching.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646867
Brief Title
Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
Official Title
An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Coria Laboratories, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
Keywords
Tetrix cream, contact dermatitis, effect on burning and itching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Device
Intervention Name(s)
Tetrix
Intervention Description
Twice daily topical application
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Twice daily topical application
Primary Outcome Measure Information:
Title
Improvement in symptoms of burning and itching.
Time Frame
after 14 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal subjects with sensitivity to nickel
Subjects with hand eczema
Exclusion Criteria:
under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Fowler, MD
Organizational Affiliation
Dermatology Specialists, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Specialists, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
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