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NCT00640614 · ClinicalTrials.gov registry record · Phase 3
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
A Phase 3 study of Contact Dermatitis, sponsored by Allerderm.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 5
- Study locations
NCT00640614: Completed Phase 3 study of Contact Dermatitis, sponsored by Allerderm.
NCT00640614 is a Phase 3 study of Contact Dermatitis that has completed, run by Allerderm. The registered enrollment target is 235 participants, above the 74-participant average among 3 other Contact Dermatitis trials with a reported enrollment target (218% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00640614, a Phase 3 study of Contact Dermatitis, has completed, sponsored by Allerderm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 5
- Study locations
Study Summary
We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.
Primary Outcome
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
Conditions Studied
Interventions
- BIOLOGICAL T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Study Locations (5)
Arkansas
- River City Dermatology - Little Rock
Kansas
- American Dermatology Associates - Shawnee Mission
Kentucky
- Dermatology Specialists PSC - Louisville
New York
- Winthrop University Hospital - Mineola
Other
- Odense University Hospital - Odense C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00640614 record still lists
NCT00640614 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, above the 74-participant average among 3 other Contact Dermatitis trials with a reported enrollment target (218% higher).
The record links to 1 condition, with Contact Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens is the first listed.
NCT00640614 lists 5 locations in 5 states (Arkansas, Kansas, Kentucky).
Frequently Asked Questions
What is clinical trial NCT00640614 about?
NCT00640614 is a clinical study titled "Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy". We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen p...
What is the current status of trial NCT00640614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2008-04. Estimated completion is 2009-10.
What conditions does trial NCT00640614 study?
This clinical trial studies the following conditions: Contact Dermatitis.
What interventions are being tested in trial NCT00640614?
The interventions under investigation include: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens (BIOLOGICAL).
Who is sponsoring clinical trial NCT00640614?
This trial is sponsored by Allerderm, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00640614 being conducted?
This trial has 5 study locations across Arkansas, Kansas, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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