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).
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1. Mycological & Clinical Cure : An assessment will be made based on the presence or absence of fungal elements in KOH preparation and mycological cure will be done at the end of the treatment and clinical improvement if evident in between (Time frame: 1-4 weeks).
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria willbe enrolled in the study. The selected subjects will receive thetest drug powder spray twicedaily for 2-4 weeks. Evaluation of the subjects will be done over 4 weeks time. Anassessment will be made based on the presence or absence offungal elements in KOH preparation and mycological cure will be done at the endof the treatment and clinical improvement if evident in between. relief of itching and scaling: (30 sec, 1 min, 2 min, 5 min, 10 min, 30min, 1 hr, 2 hr, 4 hr, 6 hr, 12 hrs and 24 hrs). subjects will beenquired regarding the symptomatic change from the initial stage and reductionin itching and scaling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group between 18 to 75 years, inclusive of both male and female subjects.
- •Subjects suffering from either candidiasis(Cutaneous Candidiasis) or Dermatophytosis (Tinea/ Ring worm) (newly diagnosed cases)
- •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
- •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 – 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.
排除标准
- •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.
结局指标
主要结局
1. Mycological & Clinical Cure : An assessment will be made based on the presence or absence of fungal elements in KOH preparation and mycological cure will be done at the end of the treatment and clinical improvement if evident in between (Time frame: 1-4 weeks).
时间窗: Week 1,2,3 and 4
2. Onset of action : (relief of itching: (30 sec, 1 min, 2 min, 5 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 12 hrs and 24 hrs).
时间窗: Week 1,2,3 and 4
3. Onset of action: (relief from scaling & skin irritation if any) : (Time frame : day1-day 28)
时间窗: Week 1,2,3 and 4
次要结局
- 1. Additionally, during each visit (week1, 2 and 3), subjects will be enquired regarding the symptomatic change from the initial stage and reduction in itching and scaling (using VAS scores) will be captured in the CRF.(2. Patient compliance and Quality of life pre and post treatment will be enquired.)