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

Primary Purpose

Dermatitis, Contact

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TRUE Test allergens Fragrance Mix and Thimerosol

About this trial

This is an interventional diagnostic trial for Dermatitis, Contact focused on measuring Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

River City Dermatology
American Dermatology Associates
Dermatology Specialists PSC
Winthrop University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Irritation, Adhesion, Itching/Burning

Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.

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

Full Information

NCT ID

NCT00612768

First Posted

January 30, 2008

Last Updated

April 6, 2018

Sponsor

Allerderm

1. Study Identification

Unique Protocol Identification Number

NCT00612768

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allerderm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Contact

Keywords

Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

TRUE Test allergens Fragrance Mix and Thimerosol

Other Intervention Name(s)

T.R.U.E. TEST Skin Patch Test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Analysis of Bioequivalence: Concordance

Description

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

Time Frame

Up to 21 days

Title

Agreement Between TRUE Test Allergen and Reference Allergen

Description

Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen

Time Frame

Up to 21 days

Secondary Outcome Measure Information:

Title

Irritation, Adhesion, Itching/Burning

Description

Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.

Time Frame

Visit 2: 48 hours after patch application

Title

Frequency of Late and Persistent Reactions

Description

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

Time Frame

Day 2 (48 hours after application) through Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Fowler, MD

Organizational Affiliation

Dermatology Specialists PSC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luz Fonacier, MD

Organizational Affiliation

Winthrop University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donald V. Belsito, MD

Organizational Affiliation

American Dermatology Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jerri Hoskyn, MD

Organizational Affiliation

River City Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

River City Dermatology

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

American Dermatology Associates

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

Facility Name

Dermatology Specialists PSC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202-1864

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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