Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
时间窗: Investigator Determination of Positive Reaction: 21 days post application
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
次要结局
- Number of Participants With Late or Persistent Positive Patch Test Reactions(Day 7-21)