Evaluating the role of dermoscopy for the interpretation of patch test results in suspected cases of Allergic contact dermatitis: A Prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- main role of the study is to evaluate the role of dermoscopy for the interpretation of patch test results in patients with suspected case of allergic contact dermatitis. in 72 positive reactions
研究概览
简要总结
Patients proforma form will be filled, demographic details will be taken and patient will be counselled for patch test and for further evaluation. Indian Standard Series kit from Contact and Occupational Dermatoses Forum of India CODFI (systopic) will be used.
Informed Consent will be taken from the patient and the procedure will be explained.
Site selection: Mostly upper back will be preferred, other sites apart from back is lateral aspect of arms, and hairy area will be avoided.
Procedure:
1. Site will be cleaned with alcohol swab and allow it to dry.2 Sheets of patch strip having 10 round aluminum finn chambers on scanapor in each strip will be taken. 20 antigens with each having 20mg gel antigen or 15µl liquid antigen will be placed over center of finn chambers on patch strips. After placing antigen, strips will be sticked over the site using micropore tape firmly and markers will be used to mark the antigen. First follow up at 48hrs (Day 2)
After 48 hrs patch strip will be removed and expose tested site to the environment and marked each tested sites with indelible marker.
After 60 min of exposure, patient will be examined first with naked eyes and if any positive reaction according to International Contact Dermatits Research Group (ICDRG)present at any site of patch, hand held dermoscopy both in polarized and non polarized mode will be used to see the reactions and both clinical and dermoscopic images will be taken.
Patient will be again explained to avoid bathing and sweating with strenuous exercise for next 48hrs for second follow up.
Second follow up at 96 hrs: (Day 4)
Again, after 96hrs, patient is examined first with naked eyes and if any positive reaction according to ICDRG present at any site of patch, hand held dermoscopy both in polarized and non polarized mode will be used to see the reactions and both clinical and dermoscopic images will be taken.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients age more than 18 years with Allergic Contact Dermatitis.
- •2.Those patients who developed any type of reaction at patch testing site after 48hrs or 96hrs.
- •3.Patients who are willing to sign the written consent form before participating in the study.
排除标准
- •1.Patients having active lesions, significant erythema or scratching over patch test site.
- •2.Patient with active infection at patch test site.
- •3.Patient with any active eczema for last 15 days.
- •4.Those taking oral steroids more than 15 mg prednisolone or any other immunosuppressive, or any form of treatment from last 1 month that known to influence the results of patch test.
- •5.Application of topical steroid or any topical anti-inflammatory at patch test result site.
- •6.History of Sunbathing at patch test results site and expose to UVR (Ultra violet radiation) 15 days prior to test.
- •7.Pregnant females and any immunocompromised patient.
结局指标
主要结局
main role of the study is to evaluate the role of dermoscopy for the interpretation of patch test results in patients with suspected case of allergic contact dermatitis. in 72 positive reactions
时间窗: It will be evaluate at day 2 and day 4
次要结局
- histopathologic correlation(at day 4)
研究者
Stuti Agrawal
All India Institute Of Medical Science