Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Allergic Contact Dermatitis Clinical Trial

Official title:

Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797562
• Other study ID #: SP 12 7NEW 401
• Status: Completed
• Phase: N/A
• Start date: December 10, 2012
• Est. completion date: September 8, 2015

Study information

• Verified date: April 2020
• Source: Allerderm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

Description:

The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 8, 2015
• Est. primary completion date: September 8, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Symptoms and history potentially consistent with allergic contact dermatitis

• Children and adolescents 6-17 years of age, 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 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

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Diagnostic Test:
• Panels 1.3, 2.2 and 3.2 experimental allergens
Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.

Locations

Country	Name	City	State
United States	Anschutz Health and Wellness Center, University of Colorado	Aurora	Colorado
United States	Dermatology Specialists	Louisville	Kentucky
United States	Oregon Health & Science University	Portland	Oregon
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Allerderm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores	Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction	Investigator Determination of Positive Reaction: 21 days post application
Secondary	Number of Participants With Late or Persistent Positive Patch Test Reactions	Late reactions are positive reactions that initially occur at 7-21 days after application of the panels.; Persistent reactions are positive reactions that persist from one visit to the next.; Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.	Day 7-21