Clinical trial NCT00612768: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Official title: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Contact
Keywords: Bioequivalence
Thimerosal
Fragrance Mix
PVP formulation
Contact dermatitis
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Analysis of Bioequivalence: Concordance
timeFrame: Up to 21 days
measure: Agreement Between TRUE Test Allergen and Reference Allergen
timeFrame: Up to 21 days
Secondary outcomes:
measure: Irritation, Adhesion, Itching/Burning
timeFrame: Visit 2: 48 hours after patch application
measure: Frequency of Late and Persistent Reactions
timeFrame: Day 2 (48 hours after application) through Day 21
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: River City Dermatology
state: Arkansas
city: Shawnee Mission
country: United States
facility: American Dermatology Associates
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists PSC
state: Kentucky
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Dermatology Specialists PSC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Winthrop University Hospital
name: Luz Fonacier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Dermatology Associates
name: Donald V. Belsito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: River City Dermatology
name: Jerri Hoskyn, MD
role: PRINCIPAL_INVESTIGATOR
References: