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Completed

NCT Number: NCT00612768

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

River City Dermatology, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: T.R.U.E. TEST Skin Patch Test

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allerderm

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 12, 2008
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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