Phase 4
Completed N=102
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Dermatitis, Contact
Source: ClinicalTrials.gov NCT00795951 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Positive Reactions: Nickel Sulfate — 30 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Reactions: Nickel Sulfate |
30 | — |
| PRIMARY Positive Reactions: Neomycin Sulfate |
8 | — |
| PRIMARY Positive Reactions: Wool Alcohol |
16 | — |
| PRIMARY Positive Reactions: Potassium Dichromate |
9 | — |
| PRIMARY Positive Reactions: Caine Mix |
— | — |
| PRIMARY Positive Reactions: Fragrance Mix |
13 | — |
| PRIMARY Positive Reactions: Colophony |
9 | — |
| PRIMARY Positive Reactions: Paraben Mix |
2 | — |
| PRIMARY Positive Reactions: Negative Control |
— | — |
| PRIMARY Positive Reactions: Balsam of Peru |
11 | — |
| PRIMARY Positive Reactions: Ethylenediamine Dihydrochloride |
5 | — |
| PRIMARY Positive Reactions: Cobalt Dichloride |
13 | — |
| PRIMARY Positive Reactions: P-tert Butylphenol Formadehyde Resin |
17 | — |
| PRIMARY Positive Reactions: Epoxy Resin |
4 | — |
| PRIMARY Positive Reactions: Carba Mix |
7 | — |
| PRIMARY Positive Reactions: Black Rubber Mix |
2 | — |
| PRIMARY Positive Reactions: Cl+Me-Isothiazolinone |
4 | — |
| PRIMARY Positive Reactions: Quaternium-15 |
4 | — |
| PRIMARY Positive Reactions: Mercaptobenzothiazole |
2 | — |
| PRIMARY Positive Reactions: p-Phenylenediamine |
2 | — |
| PRIMARY Positive Reactions: Formaldehyde |
7 | — |
| PRIMARY Positive Reactions: Mercapto Mix |
2 | — |
| PRIMARY Positive Reactions: Thimerosal |
4 | — |
| PRIMARY Positive Reactions: Thiuram Mix |
7 | — |
| PRIMARY Positive Reactions: Diazolidinyl Urea |
5 | — |
| PRIMARY Positive Reactions: Imidazolidinyl Urea |
2 | — |
| PRIMARY Positive Reactions: Budesonide |
1 | — |
| PRIMARY Positive Reactions: Tixocortol-21-pivalate |
8 | — |
| PRIMARY Positive Reactions: Quinoline Mix |
1 | — |
| SECONDARY Late Reactions: Nickel Sulfate |
1 | — |
| SECONDARY Late Reactions: Neomycin Sulfate |
1 | — |
| SECONDARY Late Reactions: Wool Alcohol |
— | — |
| SECONDARY Late Reactions: Potassium Dichromate |
— | — |
| SECONDARY Late Reactions: Caine Mix |
— | — |
| SECONDARY Late Reactions: Fragrance Mix |
— | — |
| SECONDARY Late Reactions: Colophony |
— | — |
| SECONDARY Late Reactions: Paraben Mix |
— | — |
| SECONDARY Late Reactions: Negative Control |
— | — |
| SECONDARY Late Reactions: Balsam of Peru |
— | — |
| SECONDARY Late Reactions: Ethylenediamine Dihydrochloride |
— | — |
| SECONDARY Late Reactions: Cobalt Dichloride |
1 | — |
| SECONDARY Late Reactions: P-tert Butylphenol Formadehyde Resin |
1 | — |
| SECONDARY Late Reactions: Epoxy Resin |
1 | — |
| SECONDARY Late Reactions: Carba Mix |
— | — |
| SECONDARY Late Reactions: Black Rubber Mix |
— | — |
| SECONDARY Late Reactions: Cl+Me-Isothiazolinone |
— | — |
| SECONDARY Late Reactions: Quaternium-15 |
1 | — |
| SECONDARY Late Reactions: Mercaptobenzothiazole |
— | — |
| SECONDARY Late Reactions: p-Phenylenediamine |
— | — |
| SECONDARY Late Reactions: Formaldehyde |
2 | — |
| SECONDARY Late Reactions: Mercapto Mix |
— | — |
| SECONDARY Late Reactions: Thimerosal |
— | — |
| SECONDARY Late Reactions: Thiuram Mix |
1 | — |
| SECONDARY Late Reactions: Diazolidinyl Urea |
1 | — |
| SECONDARY Late Reactions: Imidazolidinyl Urea |
1 | — |
| SECONDARY Late Reactions: Budesonide |
— | — |
| SECONDARY Late Reactions: Tixocortol-21-pivalate |
— | — |
| SECONDARY Late Reactions: Quinoline Mix |
— | — |
| SECONDARY Persistent Reactions: Nickel Sulfate |
16 | — |
| SECONDARY Persistent Reactions: Neomycin Sulfate |
5 | — |
| SECONDARY Persistent Reactions: Wool Alcohol |
6 | — |
| SECONDARY Persistent Reactions: Potassium Dichromate |
3 | — |
| SECONDARY Persistent Reactions: Caine Mix |
— | — |
| SECONDARY Persistent Reactions: Fragrance Mix |
5 | — |
| SECONDARY Persistent Reactions: Colophony |
4 | — |
| SECONDARY Persistent Reactions: Paraben Mix |
1 | — |
| SECONDARY Persistent Reactions: Negative Control |
— | — |
| SECONDARY Persistent Reactions: Balsam of Peru |
2 | — |
| SECONDARY Persistent Reactions: Ethylenediamine Dihydrochloride |
4 | — |
| SECONDARY Persistent Reactions: Cobalt Dichloride |
5 | — |
| SECONDARY Persistent Reactions: P-tert Butylphenol Formadehyde Resin |
6 | — |
| SECONDARY Persistent Reactions: Epoxy Resin |
1 | — |
| SECONDARY Persistent Reactions: Carba Mix |
1 | — |
| SECONDARY Persistent Reactions: Black Rubber Mix |
— | — |
| SECONDARY Persistent Reactions: Cl+Me-Isothiazolinone |
3 | — |
| SECONDARY Persistent Reactions: Quaternium-15 |
2 | — |
| SECONDARY Persistent Reactions: p-Phenylenediamine |
— | — |
| SECONDARY Persistent Reactions: Formaldehyde |
1 | — |
| SECONDARY Persistent Reactions: Mercapto Mix |
1 | — |
| SECONDARY Persistent Reactions: Thimerosal |
2 | — |
| SECONDARY Persistent Reactions: Thiuram Mix |
— | — |
| SECONDARY Persistent Reactions: Diazolidinyl Urea |
2 | — |
| SECONDARY Persistent Reactions: Imidazolidinyl Urea |
— | — |
| SECONDARY Persistent Reactions: Budesonide |
1 | — |
| SECONDARY Persistent Reactions: Tixocortol-21-pivalate |
3 | — |
| SECONDARY Persistent Reactions: Quinoline Mix |
— | — |
| SECONDARY Persistent Reactions: Mercaptobenzothiazole |
1 | — |
| SECONDARY Panel Adhesion Evaluation |
71; 19; 8; 2; 0; 72 | — |
| SECONDARY Panel Irritation |
38; 43; 16; 3; 37; 43 | — |
| SECONDARY Subject Reported Itching and Burning |
33; 34; 12; 21; 44; 32 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00795951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.