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Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents (PREAII)

Primary Purpose

Contact Dermatitis

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Patch Test

About this trial

This is an interventional diagnostic trial for Contact Dermatitis focused on measuring Patch Test, Contact Dermatitis, Allergy, Children, PREA

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Children and adolescents 6 to 18 years of age, and in general good health.
Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by subject. If under age, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.

Exclusion Criteria:

Topical corticosteroid treatment during the last 7 days on or near the test area.
Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
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 activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Subjects unable or unwilling to comply with multiple return visits.
Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.

Sites / Locations

Anschutz Health and Wellness Center, University of Colorado
Dermatology Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patch Test

Arm Description

Outcomes

Primary Outcome Measures

Change in Frequency and characterization of positive reactions per allergen.

Secondary Outcome Measures

Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

Full Information

NCT ID

NCT01518348

First Posted

March 16, 2011

Last Updated

February 26, 2013

Sponsor

Allerderm

1. Study Identification

Unique Protocol Identification Number

NCT01518348

Brief Title

Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

Acronym

PREAII

Official Title

Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study has been updated with new protocol number

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allerderm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.

Detailed Description

The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy and fulfill entry criteria. Visit 1 (Day 0): Informed Consent, Inclusion/Exclusion Criteria Assessment, Medical and Medicine History, Pregnancy Test (for female subjects of child-bearing potential), Panel Placement.Visit 2 (Day 2): Panel Removal, Panel Adhesion and Irritation Assessment, AE and Concomitant Medication Review.Visit 3 (Day 3- approximately 72 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 4 (Day 4 approximately 96 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 5 (Day 7±1): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit 6 (Day 21±2): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit performed via phone call, unless investigator determines that subject should be seen in clinic. Primary Endpoint: Frequency and characterization of positive reactions per allergen. Secondary Endpoint: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contact Dermatitis

Keywords

Patch Test, Contact Dermatitis, Allergy, Children, PREA

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patch Test

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Patch Test

Other Intervention Name(s)

T.R.U.E. TEST

Intervention Description

Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone

Primary Outcome Measure Information:

Title

Change in Frequency and characterization of positive reactions per allergen.

Time Frame

72 hours, 96 hours, 1 week, 21 Days

Secondary Outcome Measure Information:

Title

Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.

Time Frame

72 hours, 96 hours, 1 week, 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition). Children and adolescents 6 to 18 years of age, and in general good health. Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion. Informed consent must be signed and understood by subject. If under age, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations. Exclusion Criteria: Topical corticosteroid treatment during the last 7 days on or near the test area. Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days. Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study. 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 activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). Subjects unable or unwilling to comply with multiple return visits. Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cory Dunnick, MD

Organizational Affiliation

Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joseph Fowler, MD

Organizational Affiliation

Dermatology Specialists, Louisville, KY

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anschutz Health and Wellness Center, University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Dermatology Specialists

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents

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