Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Diagnostic Performance: Optimal Test Allergen Concentration
研究概览
简要总结
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
详细描述
Primary endpoint:
To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
- Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
- Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
- Concordance/discordance as compared to the corresponding reference petrolatum allergen.
Secondary endpoint:
To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix.
- •All subjects must be adults (18 years of age or older) and otherwise in good health.
- •Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
- •Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
排除标准
- •Subjects unable to meet inclusion requirements.
- •Women who are breastfeeding or pregnant.
- •Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
- •Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
- •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 patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- •Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.
研究组 & 干预措施
Sensitives
Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
干预措施: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens (Biological)
结局指标
主要结局
Diagnostic Performance: Optimal Test Allergen Concentration
时间窗: Visits 3-5: 3-21 days after application
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Concordance Between Investigational Allergen and Reference Allergen
时间窗: Visit 5: 21 days after patch application
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
时间窗: Visit 4: 7 days after application
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
次要结局
- Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning(Day 2-21)
- Adverse Events(Days 0-21)