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

Contact Dermatitis Clinical Trial

— PREAII  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01518348
• Other study ID #: Mekos 107P3.2 401
• Status: Withdrawn
• Phase: Phase 3
• First received: March 16, 2011
• Last updated: February 26, 2013
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Allerderm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact

Intervention

Biological:
• Patch Test
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

Locations

Country	Name	City	State
United States	Anschutz Health and Wellness Center, University of Colorado	Aurora	Colorado
United States	Dermatology Specialists	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Allerderm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency and characterization of positive reactions per allergen.		72 hours, 96 hours, 1 week, 21 Days	Yes
Secondary	Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.		72 hours, 96 hours, 1 week, 21 days	Yes