Status:
COMPLETED
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Lead Sponsor:
Allerderm
Conditions:
Dermatitis, Contact
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Detailed Description
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
Eligibility Criteria
Inclusion
- Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal.
- All subjects must be adults (18 years of age or older) and otherwise in good health.
- Pre-menopausal female subjects must consent to a urine pregnancy 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 treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
- Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents.
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
- 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).
- Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00612768
Start Date
January 1 2008
End Date
October 1 2009
Last Update
April 9 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
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