Phase 3
N=235
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00640614 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 — 78.9 percentage of concordant responses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- 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
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 |
78.9 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Concordance |
82.6 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate |
100; 57.1 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate |
92.3; 85.7 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile |
28.6; 93.3 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Bacitracin |
92.9; 50 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Parthenolide |
92.9; 100 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Disperse Blue |
88.9; 87.5 | — |
| PRIMARY Diagnostic Performance: Sensitivity and Specificity: Bronopol |
100; 78.9 | — |
| SECONDARY Safety Evaluations: All T.R.U.E. Test Allergens |
79; 123; 4 | — |
| SECONDARY Late Reactions: All T.R.U.E. Test Allergens |
6; 0; 1; 0; 1; 0 | — |
| SECONDARY Persistent Reactions: All T.R.U.E. Test Allergens |
26; 6; 4; 3; 12; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00640614). 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.