Open label, Single arm, Efficacy Study of Stop Itch anti-fungal powder Spray Containing Miconazole nitrate Spray of Amrutanjan Health Care Limited, in Patients either with Cutaneous Candidiasis or Dermatophytosis (Tinea/ Ring worm).

Amrutanjan Health Care Limited0 个研究点目标入组 45 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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•1. Subjects in the age group between 18 to 75 years, inclusive of both male and female subjects.
•2. Subjects suffering from either candidiasis(Cutaneous Candidiasis) or Dermatophytosis (Tinea/ Ring worm) (newly diagnosed cases)
•3. Patients with localized superficial fungal infection confirmed by presence of fungal hyphae in KOH (potassium hydroxide) preparation of skin scrapings from over the lesion at baseline visit
•4. Availability of subject for the entire study period and willing to adhere to protocol requirements as evidenced by the written ICF duly signed by the volunteer.
•5.Subject who have no evidence of life life-threatening disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study.
•6.Atopic patients, dry skin and diabetes mellitus â?? subjects with either of the above problem and willing not to use any other anti-fungal drugs other than the investigational product during the study period.
•7.Subjects, who are willing to avoid sun bathing, swimming, prolonged sun exposure or artificial ultra-violet rays during the course of the study.

•1.Subjects with allergies to cosmetics, moisturizers, and whitening/bleaching agents.
•2.Subjects who has sunburned, chapped, or irritated skin or open wounds on test sites.
•3.Subjects who are not willing to discontinue any other personal care products containing whitening/bleaching properties during study period.
•4.History of skin cancer or treatment for any type of cancer within the last 2 years.
•5.Subjects who are with underlying immunosuppressive state.
•6.Subjects who applied any other topical agent over the lesions prior to baseline visit.
•7.Pregnant women or nursing mothers.

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