Diagnosis of Allergic Contact Dermatitis MedDRA version: 12.1 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis
Conditions
Interventions
Product Name: TRUE TEST
Product Code: Neomycin Sulfate (methylcellulose)
Pharmaceutical Form:
INN or Proposed INN: NEOMYCIN SULFATE
CAS Number: 1405-10-3
Concentration unit: MBq/mg megabecquerel(s)/
Sponsors
SmartPractice
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 10 years) to the current T.R.U.E. TEST formulation of neomycin sulfate, AND/OR potassium dichromate. ·All subjects must be adults (18 years of age or older) and otherwise in good health. ·Female subjects of child-bearing potential must consent to a urine pregnancy test; results must be negative for study inclusion. Menopausal females (amenorrhic for >1 year) may be excluded from a pregnancy test. ·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 T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the bioequivalence of: neomycin in the current vehicle-methylcellulose as compared to neomycin in the new polyvinylpyrrolidone formulation vehicle; and potassium dichromate in the current hydroxypropyl cellulose vehicle as compared to potassium dichromate in the new polyvinylpyrrolidone formulation.;Secondary Objective: To evaluate the frequency of late/persistent reactions, irritation, tape reactions, subject self-report of itching or burning, and adverse events.;Primary end point(s): The bioequivalence of each allergen will be evaluated in adult patients with known sensitization to al least one of the T.R.U.E. TEST panel allergens (neomycin sulfate and potassium dichromate). Bioequivalence will be based on concordance (or agreement) between positive reactions to neomycin in two formulations-methylcellulose and polyvinylpyrrolidone; and positive reactions to potassium dichromate in two formulations-hydroxypropylcellulose and polyvinylpyrrolidone formulations. Secondary endpoint: To evaluate the safety of T.R.U.E. TEST panel allergens (neomycin sulfate and potassium dichromate) in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one or both of these 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