Status:
COMPLETED
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
Lead Sponsor:
Allerderm
Conditions:
Contact Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-butyrat...
Detailed Description
Primary endpoint: The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to a...
Eligibility Criteria
Inclusion
- Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
- Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
- Gold sodium thiosulfate
- Methyldibromoglutaronitrile (alone or with phenoxyethanol)
- Bacitracin
- Bronopol
- Disperse blue 106 (alone or with Disperse blue 124)
- Parthenolide (or Compositae mix)
- Hydrocortisone-17-butyrate
- All subjects must be adults over 18 years of age, and otherwise in good health.
- Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
- Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Exclusion
- Subjects unable to meet inclusion requirements.
- Women who are breastfeeding or pregnant.
- Topical corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
- Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
- Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.
- Treatment with ultraviolet (UV) light (including tanning) during the 21 days before visit
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00640614
Start Date
April 1 2008
End Date
October 1 2009
Last Update
May 5 2020
Active Locations (5)
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1
River City Dermatology
Little Rock, Arkansas, United States, 72205
2
American Dermatology Associates
Shawnee Mission, Kansas, United States, 66216
3
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202-1864
4
Winthrop University Hospital
Mineola, New York, United States, 11501