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

• Conditions: Diagnosis of Allergic Contact Dermatitis; MedDRA version: 9.1Level: LLTClassification code 10010790Term: Contact dermatitis

• Registration Number: EUCTR2008-000168-18-DK
• Lead Sponsor: Allerderm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 205

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
– 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.
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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified