Phase 2
N=50
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Dermatitis, Contact
Bottom Line
View on ClinicalTrials.gov: NCT00612768 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Apr 2018
Primary outcome: Primary: Analysis of Bioequivalence: Concordance — 76; 98.0 percentage of agreement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TRUE Test allergens Fragrance Mix and Thimerosol (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allerderm
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analysis of Bioequivalence: Concordance |
76; 98.0 | — |
| PRIMARY Agreement Between TRUE Test Allergen and Reference Allergen |
40.9; 59.1; 61.5; 65.4; 92.9; 100 | — |
| SECONDARY Irritation, Adhesion, Itching/Burning |
28; 24; 20; 46 | — |
| SECONDARY Frequency of Late and Persistent Reactions |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00612768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.