Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

October 31, 2009

Conditions
Contact Dermatitis
Interventions
BIOLOGICAL

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

"Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP~Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours."

Trial Locations (5)

11501

Winthrop University Hospital, Mineola

66216

American Dermatology Associates, Shawnee Mission

72205

River City Dermatology, Little Rock

40202-1864

Dermatology Specialists PSC, Louisville

DK-5000

Odense University Hospital, Odense C

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allerderm

INDUSTRY

NCT00640614 - Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy | Biotech Hunter | Biotech Hunter