EUCTR2008-000168-18-DKActive, not recruitingNot Applicable
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol - Safety and Efficacy Trial
Allerderm0 sites205 target enrollmentStarted: February 27, 2008Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 205
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •·Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis (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 5 years.
- •– gold sodium thiosulfate
- •– methyldibromoglutaronitrile (alone or with phenoxyethanol)
- •– bacitracin
- •– 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •·Subjects unable to meet inclusion requirements.·Breastfeeding or prenancy.
- •·Topical corticosteroid treatment during the last 7 days on or near the test area.
- •·Systemic treatment with corticosteroids or other immunosuppressive during the last 7 days.
- •·Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
- •·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).
Investigators
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