drugset / Trial / NCT00640614
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
Non-randomizedSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-08
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacitracin | Unknown | 0.6 unknown | Other |
| Subject | Bronopol | Small molecule | 0.25 unknown | Other |
| Subject | Disperse Blue 106 | Unknown | 0.05 unknown | Other |
| Subject | Gold Sodium Thiosulfate | Unknown | 0.075 unknown | Other |
| Subject | Hydrocortisone Butyrate | Unknown | 0.02 unknown | Other |
| Subject | Methyldibromoglutaronitrile | Unknown | 0.0055 unknown | Other |
| Subject | parthenolide | Small molecule | 0.003 unknown | Other |