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

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ClinicalTrials.gov Identifier: NCT00612768
Recruitment Status : Completed
First Posted : February 12, 2008
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Allerderm

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Contact Biological: TRUE Test allergens Fragrance Mix and Thimerosol Phase 2

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  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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

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



Primary Outcome Measures :
  1. Analysis of Bioequivalence: Concordance [ Time Frame: Up to 21 days ]
    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

  2. Agreement Between TRUE Test Allergen and Reference Allergen [ Time Frame: Up to 21 days ]
    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 :
  1. Irritation, Adhesion, Itching/Burning [ Time Frame: Visit 2: 48 hours after patch application ]
    Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.

  2. Frequency of Late and Persistent Reactions [ Time Frame: Day 2 (48 hours after application) through Day 21 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612768


Locations
United States, Arkansas
River City Dermatology
Little Rock, Arkansas, United States, 72205
United States, Kansas
American Dermatology Associates
Shawnee Mission, 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

Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT00612768     History of Changes
Other Study ID Numbers: Mekos 07 2P1/2 401
20071738 ( Other Identifier: Western Institutional Review Board )
First Posted: February 12, 2008    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Povidone
Benzocaine
Plasma Substitutes
Blood Substitutes
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents