Role of Patch testing in Lip and Eyelid Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Itching or Faint erythema or papules or pustules or vesicles at the site of patch test
研究概览
简要总结
Patients above the age of 18years with symptoms of Lip and eyelid dermatitis will be included in the study. A total of 3 visits to the hospital has to be done for Patch testing. Patch testing will be done using ISS (Indian Standard Series) and Cosmetic Series. On the first visit, a detailed history is taken with regard to the possible allergen exposures, occupation, cosmetic use. A total of 55 patches (20+32) will be kept on the posterior trunk and upper arms (if required) using standard aluminium chambers. Second visit is on the Day 3 (48 hours), when patches will be removed and reading will be done as per the ICDRG guideline. Third visit will be on Day 4 (72 hours) when second reading will be done. In case of excessive itching or discomfort, patch will be removed prior to 48 hours and patient will be withdrawn from the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients above 18 years of age and less than 60years
- •Patients attending dermatology OP with lip and eye lid dermatitis.
- •Patients consenting for patch test.
排除标准
- •Patients on any immunosuppressive treatment (eg : oral corticosteroids, azathioprine, cyclosporine, tofacitinib)
- •Patients having extensive active dermatitis, exfoliative dermatitis
- •Pregnant patients
- •Patients having lesions on the back which will interfere with the application of patch or reading
- •Patients who are unable to come for 48 hour and 72-hour reading.
结局指标
主要结局
Itching or Faint erythema or papules or pustules or vesicles at the site of patch test
时间窗: first reading at 48 hours after application of patch and second reading at 72 hours
次要结局
- Itching or Faint erythema or papules or pustules or vesicles at the site of patch test(Patch test site positive reaction occurring after 72 hours)
研究者
Dr Aravind Suprakasan
Kasturba Medical College, Manipal