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

• Sponsor: Allerderm (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00612768
• Collaborator: (none)
• Enrollment: 50
• Locations: 4
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• 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: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: T.R.U.E. Test allergens Fragrance Mix and Thimerosol Concordance (agreement) between positive patch reactions to fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC) thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC) fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum) 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 Names: T.R.U.E. TEST Skin Patch Test

Outcome Measures

Primary Outcome Measures

1. Analysis of Bioequivalence: Concordance [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	River City Dermatology	Little Rock	Arkansas	United States	72205
2	American Dermatology Associates	Shawnee Mission	Kansas	United States	66216
3	Dermatology Specialists PSC	Louisville	Kentucky	United States	40202-1864
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allerderm
• ClinicalTrials.gov Identifier: NCT00612768
• Other Study ID Numbers: Mekos 07 2P1/2 401; 20071738
• First Posted: Feb 12, 2008
• Last Update Posted: Apr 9, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Allerderm: Bioequivalence; Thimerosal; Fragrance Mix; PVP formulation; Contact dermatitis
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Contact

Study Results

Participant Flow

Recruitment Details	The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.
Pre-assignment Detail	No subject was excluded from the trial following enrollment but before assignment to a group.

Arm/Group Title	Sensitive Subjects
Arm/Group Description	All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sensitive Subjects
Arm/Group Description	Subjects 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.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 80%
>=65 years	10 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.4 (16.72)
Sex: Female, Male (Count of Participants)
Female	37 74%
Male	13 26%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	Analysis of Bioequivalence: Concordance
Description	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
Time Frame	Up to 21 days

Outcome Measure Data

Analysis Population Description

The data from 50 subjects enrolled in the study was analyzed

Arm/Group Title	Fragrance Mix	Thimerosol
Arm/Group Description	Percent agreement between T.R.U.E. Test allergen in PVP vs HPC	Percent agreement between T.R.U.E. Test allergen in PVP vs HPC
Measure Participants	50	50
Number (95% Confidence Interval) [percentage of agreement]	76	98.0

2. Primary Outcome

Title	Agreement Between TRUE Test Allergen and Reference Allergen
Description	Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen
Time Frame	Up to 21 days

Outcome Measure Data

Analysis Population Description

The data from all enrolled subjects was analyzed.

Arm/Group Title	Sensitivity: Fragrance Mix in HPC	Sensitivity: Fragrance Mix in PVP	Sensitivity: Thimerosal in HPC	Sensitivity: Thimerosol in PVP	Specificity: Fragrance Mix in HPC	Specificity: Fragrance Mix in PVP	Specificity: Thimerosal in HPC	Specificity: Thimerosal in PVP
Arm/Group Description	Agreement between positive results for the test and reference allergen	Agreement between positive results for the test and reference allergen	Agreement between positive results for the test and reference allergen	Agreement between positive results for the test and reference allergen	Agreement between negative results for the test and reference allergen	Agreement between negative results for the test and reference allergen	Agreement between negative results for the test and reference allergen	Agreement between negative results for the test and reference allergen
Measure Participants	50	50	50	50	50	50	50	50
Number (95% Confidence Interval) [percentage of agreement]	40.9	59.1	61.5	65.4	92.9	100	100	100

3. Secondary Outcome

Title	Irritation, Adhesion, Itching/Burning
Description	Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.
Time Frame	Visit 2: 48 hours after patch application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tape Irritation: TRUE Test Panel	Incomplete Panel Adhesion: TRUE Test	Incomplete Panel Adhesion: Reference Allergen	Itching and Burning
Arm/Group Description	Percentage of participants who exhibited tape-induced irritation at visit 2.	Percentage of participants whose panels were not 100% adhered at visit 2.	Percentage of participants whose panels were not 100% adhered at visit 2.	Percentage of participants who reported patch related itching and/or burning at visit 2
Measure Participants	50	50	50	50
Number [percentage of participants]	28 56%	24 NaN	20 NaN	46 NaN

4. Secondary Outcome

Title	Frequency of Late and Persistent Reactions
Description	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
Time Frame	Day 2 (48 hours after application) through Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Late Reactions: Fragrance Mix in HPC	Late Reactions: Fragrance Mix in PVP	Late Reactions: Thimerosal in HPC	Late Reactions: Thimerosol in PVP	Persistent Reactions: Fragrance Mix in HPC	Persistent Reactions: Fragrance Mix in PVP	Persistent Reactions: Thimerosal in HPC	Persistent Reactions: Thimerosal in PVP
Arm/Group Description	Late reactions occur 7-10 days after patch application	Late reactions occur 7-10 days after patch application	Late reactions occur 7-10 days after patch application	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	Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application	Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application	Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Measure Participants	50	50	50	50	50	50	50	50
Number [percentage of subjects with reactions]	0	0	0	0	0	0	4	4

Adverse Events

Time Frame	Day 0-21
Arm/Group Title	Sensitives
Arm/Group Description	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.
All Cause Mortality
	Sensitives
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sensitives
	Affected / at Risk (%)	# Events
Total	1/50 (2%)
Cardiac disorders
Right femoral sheath placed secondary to tronsientischemic attack/carotid stenosis	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Sensitives
	Affected / at Risk (%)	# Events
Total	5/50 (10%)
Gastrointestinal disorders
Bladder Infection	1/50 (2%)
Skin and subcutaneous tissue disorders
Itching	1/50 (2%)
Itching and burning	1/50 (2%)
Itching on/around site	1/50 (2%)
Reports burning sensation, she thinks it might be due to the tape	1/50 (2%)
Itching at positive patch sites	1/50 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.