Diagnosis of Allergic Contact Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10010790 Term: Contact dermatitis
Conditions
Interventions
Product Name: TRUE TEST Panel 3.2
Pharmaceutical Form:
CAS Number: 10233-88-2
Other descriptive name: Gold Sodium Thiosulfate
Concentration type: equal
Concentration number: 0.075mg/cm2 -
Product N
Sponsors
Allerderm
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic performance 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 six allergens.;Secondary Objective: To diagnose the safety of compare the safety of of seven new T.R.U.E. TEST allergens: gold sodium thiosulfate, hydrocortisone-17-butyrate, bacitracin, parthenolide, methyldibromoglutaronitrile, disperse blue 106, and Bronopol.;Primary end point(s): The performance (efficacy) of each allergen 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 six allergens. Performance will be based on: ·Calculated concordance/discordance between T.R.U.E. TEST Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens. ·Calculated sensitivity and specificity for T.R.U.E. TEST Panel 3.2 allergens. Secondary endpoint: To evaluate the safety of seven T.R.U.E. TEST Panels 3.2 allergens (gold sodium thiosulfate, hydrocortisone-17-butryate, methyldibromoglutaronitrile, bacitracin, parthenolide, disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis (“consecutives”), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 6 allergens (“sensitives”). Evaluations will be based on: ·The frequency and characterization of late and/or persistent reactions ·Tape-induced irritation at the test site ·Incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period. | — |
Countries
Denmark
Outcome results
None listed