An Open label Single Arm Multicentric Clinical Study to Evaluate the Safety and Efficacy of HVGC-091525 in the Management of Dermatitis

The Himalaya Drug Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Both male and female subject presenting with signs and symptoms of various dermatitis such as allergic, irritant, nummular, dyshidrosis(pompholyx) and pityriasis alba
•Subject presenting with signs and symptoms of dermatitis such as like, pain, itching, burning, dryness, redness, induration, peeling, scaling, fissure, vesicles and bullae
•Both male and female subject aged between 18-65 years, both inclusive at the time of consent
•Investigators Static Global Assessment ISGA score of 2 mild or 3 moderate
•Subject has contact dermatitis covering between 0.5% to 10% of the total Body Surface Area (BSA at Screening/Day 1.
•Subject must be willing and able to avoid the causative allergens during the study.

•Clinically infective and atopic dermatitis
•Any dermatological condition other than irritant dermatitis
•History of allergy or sensitivity to investigational product
•Current diagnosis or history or any disease, which in the Investigators opinion would contraindicate the use of IP
•Subjects using steroids or any other medications for the same indication in last 2 weeks and not willing to discontinue the treatment
•Pregnant and lactating women
•History of ongoing, chronic or recurrent infectious disease / lymphoproliferative disease or history of malignancy of any organ system within the past 5 years
•History of Alcohol or smoking abuse
•Patients unwilling to provide informed consent or abide by the requirements of the study

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