Trial Outcomes & Findings for Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents (NCT NCT00795951)

NCT ID: NCT00795951

Last Updated: 2020-08-06

Results Overview

Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
• Results posted on: 2020-08-06

Participant Flow

Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)

No significant events or approaches

Participant milestones

Measure	All Subjects T.R.U.E. Test Allergen Panel evaluations
Overall Study STARTED	102
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	All Subjects T.R.U.E. Test Allergen Panel evaluations
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

Baseline characteristics by cohort

Measure	Single Arm Study n=102 Participants All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
Age, Categorical <=18 years	102 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	11.6 years STANDARD_DEVIATION 3.61 • n=93 Participants
Sex: Female, Male Female	53 Participants n=93 Participants
Sex: Female, Male Male	49 Participants n=93 Participants
Region of Enrollment United States	102 participants n=93 Participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Nickel Sulfate	30 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Neomycin Sulfate	8 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Wool Alcohol	16 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Potassium Dichromate	9 participants

PRIMARY outcome

Timeframe: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Caine Mix	0 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Fragrance Mix	13 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Colophony	9 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Paraben Mix	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Negative Control	0 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Balsam of Peru	11 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Ethylenediamine Dihydrochloride	5 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Cobalt Dichloride	13 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: P-tert Butylphenol Formadehyde Resin	17 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Epoxy Resin	4 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Carba Mix	7 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Black Rubber Mix	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Cl+Me-Isothiazolinone	4 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Quaternium-15	4 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Mercaptobenzothiazole	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: p-Phenylenediamine	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Formaldehyde	7 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Mercapto Mix	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Thimerosal	4 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Thiuram Mix	7 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Diazolidinyl Urea	5 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Imidazolidinyl Urea	2 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Budesonide	1 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Tixocortol-21-pivalate	8 participants

PRIMARY outcome

Timeframe: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with positive reactions recorded at visit 3 and/or visit 4

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Positive Reactions: Quinoline Mix	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Nickel Sulfate	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Neomycin Sulfate	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Wool Alcohol	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Potassium Dichromate	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Caine Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Fragrance Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Colophony	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Paraben Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Negative Control	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Balsam of Peru	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Ethylenediamine Dihydrochloride	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Cobalt Dichloride	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: P-tert Butylphenol Formadehyde Resin	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Epoxy Resin	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Carba Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Black Rubber Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Cl+Me-Isothiazolinone	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Quaternium-15	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Mercaptobenzothiazole	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: p-Phenylenediamine	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Formaldehyde	2 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Mercapto Mix	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Thimerosal	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Thiuram Mix	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Diazolidinyl Urea	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Imidazolidinyl Urea	1 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Budesonide	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Tixocortol-21-pivalate	0 participants

SECONDARY outcome

Timeframe: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Late Reactions: Quinoline Mix	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Nickel Sulfate	16 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Neomycin Sulfate	5 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Wool Alcohol	6 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Potassium Dichromate	3 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Caine Mix	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Fragrance Mix	5 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Colophony	4 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Paraben Mix	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Negative Control	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Balsam of Peru	2 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Ethylenediamine Dihydrochloride	4 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Cobalt Dichloride	5 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: P-tert Butylphenol Formadehyde Resin	6 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Epoxy Resin	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Carba Mix	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Black Rubber Mix	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Cl+Me-Isothiazolinone	3 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Quaternium-15	2 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: p-Phenylenediamine	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Formaldehyde	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Mercapto Mix	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Thimerosal	2 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Thiuram Mix	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Diazolidinyl Urea	2 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Imidazolidinyl Urea	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Budesonide	1 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Tixocortol-21-pivalate	3 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Quinoline Mix	0 participants

SECONDARY outcome

Timeframe: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application

Population: Number of participants analyzed includes all subjects who completed the study.

Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Persistent Reactions: Mercaptobenzothiazole	1 participants

SECONDARY outcome

Timeframe: Visit 2 (day 1) prior to panel removal.

Population: All subjects who completed the study are included in the analysis.

Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Panel Adhesion Evaluation Panel 2 Adhesion Scores · Fell off	0 Participants
Panel Adhesion Evaluation Panel 3 Adhesion Scores · Excellent	82 Participants
Panel Adhesion Evaluation Panel 3 Adhesion Scores · Good	14 Participants
Panel Adhesion Evaluation Panel 3 Adhesion Scores · Fair	3 Participants
Panel Adhesion Evaluation Panel 3 Adhesion Scores · Poor	1 Participants
Panel Adhesion Evaluation Panel 1 Adhesion Scores · Excellent	71 Participants
Panel Adhesion Evaluation Panel 1 Adhesion Scores · Good	19 Participants
Panel Adhesion Evaluation Panel 1 Adhesion Scores · Fair	8 Participants
Panel Adhesion Evaluation Panel 1 Adhesion Scores · Poor	2 Participants
Panel Adhesion Evaluation Panel 1 Adhesion Scores · Fell off	0 Participants
Panel Adhesion Evaluation Panel 2 Adhesion Scores · Excellent	72 Participants
Panel Adhesion Evaluation Panel 2 Adhesion Scores · Good	19 Participants
Panel Adhesion Evaluation Panel 2 Adhesion Scores · Fair	9 Participants
Panel Adhesion Evaluation Panel 2 Adhesion Scores · Poor	0 Participants
Panel Adhesion Evaluation Panel 3 Adhesion Scores · Fell off	0 Participants

SECONDARY outcome

Timeframe: Visit 2 (day 1) following to panel removal.

Population: All subjects who completed the study are included in the analysis.

Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Panel Irritation Panel 1 Irritation · None	38 Participants
Panel Irritation Panel 3 Irritation · Weak	40 Participants
Panel Irritation Panel 3 Irritation · Moderate	18 Participants
Panel Irritation Panel 3 Irritation · Strong	2 Participants
Panel Irritation Panel 1 Irritation · Weak	43 Participants
Panel Irritation Panel 1 Irritation · Moderate	16 Participants
Panel Irritation Panel 1 Irritation · Strong	3 Participants
Panel Irritation Panel 2 Irritation · None	37 Participants
Panel Irritation Panel 2 Irritation · Weak	43 Participants
Panel Irritation Panel 2 Irritation · Moderate	16 Participants
Panel Irritation Panel 2 Irritation · Strong	4 Participants
Panel Irritation Panel 3 Irritation · None	40 Participants

SECONDARY outcome

Timeframe: Visit 2 (day 1) following to panel removal.

Population: All subjects who completed the study are included in the analysis.

Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)

Outcome measures

Measure	All Subjects n=100 Participants T.R.U.E. Test allergen panel evaluations
Subject Reported Itching and Burning Panel 1 Itching and Burning · None	33 Participants
Subject Reported Itching and Burning Panel 1 Itching and Burning · Weak	34 Participants
Subject Reported Itching and Burning Panel 1 Itching and Burning · Moderate	12 Participants
Subject Reported Itching and Burning Panel 1 Itching and Burning · Strong	21 Participants
Subject Reported Itching and Burning Panel 2 Itching and Burning · Weak	32 Participants
Subject Reported Itching and Burning Panel 2 Itching and Burning · Moderate	15 Participants
Subject Reported Itching and Burning Panel 2 Itching and Burning · Strong	9 Participants
Subject Reported Itching and Burning Panel 3 Itching and Burning · None	60 Participants
Subject Reported Itching and Burning Panel 3 Itching and Burning · Weak	23 Participants
Subject Reported Itching and Burning Panel 3 Itching and Burning · Moderate	5 Participants
Subject Reported Itching and Burning Panel 3 Itching and Burning · Strong	12 Participants
Subject Reported Itching and Burning Panel 2 Itching and Burning · None	44 Participants

Adverse Events

Safety

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Safety n=102 participants at risk Adverse Events
Skin and subcutaneous tissue disorders Worsening of rash	25.5% 26/102 • Number of events 34 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Flare-up of rash	2.0% 2/102 • Number of events 2 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Boil on forehead	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Rash	2.0% 2/102 • Number of events 2 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Vascular disorders Headache	2.0% 2/102 • Number of events 2 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Infections and infestations Fever	2.0% 2/102 • Number of events 2 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Reaction around panel 2.1	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Edema, vesiculation pain on hands	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Worsening of underlying condition	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Slight worsening of spot on leg	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Lesion on right thumb	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Worsening of dermatitis	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
Skin and subcutaneous tissue disorders Reaction on place of panel	0.98% 1/102 • Number of events 1 • The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.

Additional Information

SE Jacob, MD and L Eichenfield, MD

Rady Children's Hospital, San Diego, CA

Phone: 858-576-1700

Email: leichenfield@rchsd.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place