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

NCT ID: NCT00612768

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-10-31

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.

Conditions

Dermatitis, Contact

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

TRUE Test allergens Fragrance Mix and Thimerosol

Intervention Type: BIOLOGICAL

• 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists PSC

Luz Fonacier, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Donald V. Belsito, MD

Role: PRINCIPAL_INVESTIGATOR

American Dermatology Associates

Jerri Hoskyn, MD

Role: PRINCIPAL_INVESTIGATOR

River City Dermatology

Locations

River City Dermatology

Little Rock, Arkansas, United States

American Dermatology Associates

Shawnee Mission, Kansas, United States

Dermatology Specialists PSC

Louisville, Kentucky, United States

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

20071738

Identifier Type: OTHER

Identifier Source: secondary_id

Mekos 07 2P1/2 401

Identifier Type: -

Identifier Source: org_study_id