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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allerderm
ClinicalTrials.gov Identifier:
NCT00612768
First received: January 30, 2008
Last updated: February 19, 2013
Last verified: May 2010
History of Changes
  Purpose

An open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.


Condition Intervention Phase
Dermatitis, Contact
 Biological: TRUE TEST Skin patch test Bioequivalence
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of PVP Formulations

Resource links provided by NLM:

Drug Information available for: Thimerosal
U.S. FDA Resources

Further study details as provided by Allerderm:

Primary Outcome Measures:
  • Bioequivalence between positive reactions to both fragrance mix and thimerosal each in PVP and HPC formulations. [ Time Frame: End of study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of late/persistent reactions, irritation, tape reactions, subject self-report of itching or burning, and adverse events. [ Time Frame: End of study. ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensitives
subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
 Biological: TRUE TEST Skin patch test Bioequivalence
  • 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 Name: T.R.U.E. TEST Skin Patch Test

Detailed Description:

We are conducting an open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens. Bioequivalence will be determined in 40 adult subjects, 20 per allergen, with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612768

Locations
United States, Arkansas
River City Dermatology
Little Rock, Arkansas, United States, 72205
United States, Kansas
American Dermatology Associates
Shawnee, Kansas, United States, 66216
United States, Kentucky
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202-1864
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Allerderm
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT00612768     History of Changes
Other Study ID Numbers: Mekos 07 2P1/2 401, 20071738
Study First Received: January 30, 2008
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Allerderm:
Bioequivalence
Thimerosal
Fragrance Mix
PVP formulation
Contact dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on May 19, 2013