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

NCT00612768 | Completed Phase 2 Results

• 2 other identifiers: Mekos 07 2P1/2 40120071738
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Dermatitis, Contact

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Irritation, Adhesion, Itching/Burning

  Visit 2: 48 hours after patch application

• Frequency of Late and Persistent Reactions

  Day 2 (48 hours after application) through Day 21

Study Arms (1)

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

EXPERIMENTAL

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

Biological: TRUE Test allergens Fragrance Mix and Thimerosol

Interventions

TRUE Test allergens Fragrance Mix and Thimerosol 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.

Also known as: T.R.U.E. TEST Skin Patch Test

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Allerderm: lead

Study Sites (4)

River City Dermatology

Little Rock, Arkansas, 72205, United States

Location

American Dermatology Associates

Shawnee Mission, Kansas, 66216, United States

Location

Dermatology Specialists PSC

Louisville, Kentucky, 40202-1864, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact

Interventions

Thimerosal

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Ethylmercury Compounds; Alkylmercury Compounds; Organomercury Compounds; Organometallic Compounds; Organic Chemicals

Results Point of Contact

• Title: Kathy Shannon
• Organization: SmartPractice

kshannon@smarthealth.com

602-225-0595

Study Officials

• Joseph Fowler, MD

  Dermatology Specialists PSC

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 12, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-04

Locations

US (4)