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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Contact
• Intervention / Treatment: Biological: TRUE Test allergens Fragrance Mix and Thimerosol

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • River City Dermatology
  • Kansas
    • Shawnee Mission, Kansas, United States, 66216
      • American Dermatology Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40202-1864
      • Dermatology Specialists PSC
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: T.R.U.E. Test allergens Fragrance Mix and Thimerosol; Concordance (agreement) between positive patch reactions to; fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC); thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC); fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum); thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum) will be measured

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.; Other Names: T.R.U.E. TEST Skin Patch Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Bioequivalence: Concordance	Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit	Up to 21 days
Agreement Between TRUE Test Allergen and Reference Allergen	Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritation, Adhesion, Itching/Burning	Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.	Visit 2: 48 hours after patch application
Frequency of Late and Persistent Reactions	Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application	Day 2 (48 hours after application) through Day 21

Collaborators and Investigators

• Sponsor: Allerderm
• Investigators: Principal Investigator: Luz Fonacier, MD, Winthrop University Hospital; Principal Investigator: Donald V. Belsito, MD, American Dermatology Associates; Principal Investigator: Jerri Hoskyn, MD, River City Dermatology

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: January 30, 2008
• First Submitted That Met QC Criteria: January 30, 2008
• First Posted (ESTIMATE): February 12, 2008

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Bioequivalence; Contact dermatitis; Thimerosal; Fragrance Mix; PVP formulation
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: Mekos 07 2P1/2 401; 20071738 (OTHER: Western Institutional Review Board)