CTRI/2021/03/032235CompletedPhase 3
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).
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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