Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

Allerderm Laboratories

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Contact

Treatments: Biological: TRUE Test allergens Fragrance Mix and Thimerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612768

Mekos 07 2P1/2 401

20071738 (Other Identifier)

Details and patient eligibility

About

Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.

Full description

Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal.
• All subjects must be adults (18 years of age or older) and otherwise in good health.
• Pre-menopausal 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.

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

T.R.U.E. Test allergens Fragrance Mix and Thimerosol

Experimental group

Description:

Concordance (agreement) between positive patch reactions to 1. fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC) 2. thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC) 3. fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum) 4. thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum) will be measured

Treatment:

Biological: TRUE Test allergens Fragrance Mix and Thimerosol