Allergic Contact Dermatitis Clinical Trial
Official title:
Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
Verified date | April 2020 |
Source | Allerderm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Allerderm |
United States,
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 |
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