Diagnosis of Allergic Contact Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis
Conditions
Interventions
Product Name: TRUE TEST Panel 3.2 Allergens
Pharmaceutical Form:
INN or Proposed INN: 2-Bromo-2-nitropropane-1,3-diol (Bronopol)
CAS Number: 52-51-7
Current Sponsor code: 2-Bromo-2-nitropropane-1,3-d
Sponsors
Allerderm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol ORCurrent or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to disperse blue 106 or disperse blue 106/124 allergen mix. *All subjects must be adults (18 years of age or older) and otherwise in good health. *Premenopausal female subjects must consent to a urine pregnancy 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.· Women who are breastfeeding or pregnant. *Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. *Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents. *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). *Subject participation in clinical trials of investigational drugs, treatments or devices other than TRUE TEST during this study or 3 weeks prior to inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the diagnostic performance of 3 concentrations of disperse blue 106 and 4 concentrations of Bronopol in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen (“sensitives”).;Secondary Objective: To compare the safety of 3 concentrations of disperse blue 106 and 4 concentrations of Bronopol in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen (“sensitives”).;Primary end point(s): Determination of optimal test allergen concentration as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects; frequency of positive, negative, doubtful and irritant reactions for each allergen and concentration; and overall concordance and discordance as compared to the reference petrolatum allergens. Secondary Endpoint: Frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen and concentration. | — |
Countries
Denmark
Outcome results
None listed