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

Dermatitis, Contact Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612768
• Other study ID #: Mekos 07 2P1/2 401
• Secondary ID: 20071738
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2008
• Last updated: April 6, 2018
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: April 2018
• Source: Allerderm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact

Intervention

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 ß-cyclodextrin Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with ß-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.

Locations

Country	Name	City	State
United States	River City Dermatology	Little Rock	Arkansas
United States	Dermatology Specialists PSC	Louisville	Kentucky
United States	Winthrop University Hospital	Mineola	New York
United States	American Dermatology Associates	Shawnee Mission	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Allerderm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Irritation, Adhesion, Itching/Burning	Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.	Visit 2: 48 hours after patch application
Secondary	Frequency of Late and Persistent Reactions	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	Day 2 (48 hours after application) through Day 21