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

NCT ID: NCT00795951

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-11-30

Brief Summary

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

Detailed Description

Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

Conditions

Dermatitis, Contact

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TRUE Test panels 1.1, 2.1, 3.1

All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control.

Group Type: EXPERIMENTAL

T.R.U.E. Test

Intervention Type: BIOLOGICAL

48 hour application of 28 allergens and negative control

Interventions

T.R.U.E. Test

48 hour application of 28 allergens and negative control

Intervention Type: BIOLOGICAL

Other Intervention Names

NA no other names

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 underage, 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 immunosuppressive 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Eichenfield, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD School of Medicine

Locations

Rady Children's Hospital

San Diego, California, United States

Countries

United States

Other Identifiers

MEKOS 07 29P1/2/3/401

Identifier Type: -

Identifier Source: org_study_id