Phase 2
N=48
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00640250 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Diagnostic Performance: Optimal Test Allergen Concentration — 38.1; 47.6; 52.4; 30.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allerderm
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Performance: Optimal Test Allergen Concentration |
38.1; 47.6; 52.4; 30.8; 23.1; 46.2 | — |
| PRIMARY Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration |
14.9; 17.0; 21.3; 29.8; 78.7; 74.5 | — |
| PRIMARY Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration |
14.9; 17.0; 21.3; 29.8; 78.7; 74.5 | — |
| PRIMARY Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration |
14.9; 17.0; 21.3; 29.8; 78.7; 74.5 | — |
| PRIMARY Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration |
14.9; 17.0; 21.3; 29.8; 78.7; 74.5 | — |
| PRIMARY Concordance Between Investigational Allergen and Reference Allergen |
81.0; 95.2; 90.5; 84.6; 100.0; 76.9 | — |
| SECONDARY Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning |
71.4; 65.4; 76.2; 73.1; 0; 0 | — |
| SECONDARY Adverse Events |
1; 1 | — |
Summary
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
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 Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.
- All subjects must be adults (18 years of age or older) and otherwise in good health.
- Premenopausal 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 (NCT00640250). 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.