NCT00612768

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Allerderm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Dermatitis, Contact

Interventions

Type	Name	Description
BIOLOGICAL	TRUE Test allergens Fragrance Mix and Thimerosol	* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2009-10-01
• First posted: 2008-02-12
• Last updated: 2018-04-09
• Results posted: 2018-04-09

Locations

4 sites across 1 country: United States