- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646867
Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
May 19, 2008 updated by: Coria Laboratories, Ltd.
An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis
To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Dermatology Specialists, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal subjects with sensitivity to nickel
- Subjects with hand eczema
Exclusion Criteria:
under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Twice daily topical application
|
Experimental: 1
Experimental
|
Twice daily topical application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in symptoms of burning and itching.
Time Frame: after 14 days of treatment
|
after 14 days of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Fowler, MD, Dermatology Specialists, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (Estimate)
March 31, 2008
Study Record Updates
Last Update Posted (Estimate)
May 22, 2008
Last Update Submitted That Met QC Criteria
May 19, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 805 806 09 004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Mekos Laboratories ASUnknown
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Andreas Syggros Hospital of Venereal and Dermatological...RecruitingAllergic Contact DermatitisGreece
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-
Rockefeller UniversityWashington University School of Medicine; Tel Aviv UniversityCompleted
-
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Clinical Trials on Tetrix
-
Coria Laboratories, Ltd.Completed
-
Coria Laboratories, Ltd.CompletedHealthyUnited States
-
Coria Laboratories, Ltd.Completed