A randomized, open label, prospective investigator initiated interventional study to understand the effects of addition of broad-spectrum antimicrobial skin healing cream (Silversol plus coconut oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an antifungal agent in the management of superficial skin fungal infections.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- A total of 100 patients (50 per arm) with superficial fungal infections
研究概览
简要总结
Title A randomized, open label, prospective investigator initiated
interventional study to understand the effects of addition of broad-
spectrum antimicrobial skin healing cream (Silversol plus coconut
oil plus vitamin E plus Hyaluronic acid) as an adjuvant to an
antifungal agent in the management of superficial skin fungal
infections.
Study Description This is an investigator-initiated study. This study is based on the
hypothesis that the addition of an adjuvant antimicrobial skin
healing cream to an antifungal therapy will lead to better outcomes
in terms of better mycological cure and reduction in relapse rates
in the management of superficial skin fungal infections.
Phase of Study Post marketing investigator-initiated study (IIS)
Investigational
Products
Silversol, Coconut oil, Vitamin E, and Hyaluronic acid
combination, as an advanced patented broad spectrum
antimicrobial skin healing cream plus topical luliconazole or oral
itraconazole or both
Study population Male and female Indian population between 18 and 70 years old
clinically and mycologically diagnosed (positive KOH) to be
suffering from tinea cruris or tinea corporis.
Primary Objective To observe the effect of an addition of broad-spectrum
antimicrobial skin healing cream to antifungal therapy on clinical
and mycological cure
Secondary
Objectives
To observe effect of addition of broad-spectrum antimicrobial skin
healing cream to antifungal therapy on relapse and recurrence &
To observe tolerability of broad-spectrum antimicrobial skin
healing cream in real world.
Sample Size Total of 100 patients will be recruited (50 patients in each of the
two arms).
4 weeks
Duration of Study
drug Treatment
Duration of Follow
up
The first follow up will be at the end of 4th week (EOT). Post
treatment follow ups will be at week 10 (to check recurrence) and
at week 12 (to check relapse)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 (Completed) and 70 yrs Positive for KOH test Able to comply to the prescribed therapy Able to give informed consent.
排除标准
- •Patient with a known history or clinical evidence of severe cardiac, renal, or hepatic disease (in case of oral itraconazole is prescribed) Pregnant or lactating women (in case of oral itraconazole is prescribed) Treatment with any antipruritic medication including antihistamine within previous 72 hours Systemic antibiotics in the previous 2 weeks Corticosteroid or immunosuppressant in the past 6 weeks • Any investigational drug in the previous 3 months.
结局指标
主要结局
A total of 100 patients (50 per arm) with superficial fungal infections
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
(Tinea cruris, Tinea corporis) will be recruited together for both arms.Primary efficacy will be determined by clinical and mycological
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
assessment of lesion at baseline and at end of treatment (EOT) phase.
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
For clinical cure the following signs and symptoms will be assessed:
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
erythema, pruritus, and scaling. Each parameter will be measured on
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
4-point scale
时间窗: Baseline visit (Visit 1): Week 1 | • Follow-up 1 (Visit 2): End of week 4 | • Follow-up 2 (Visit 3): End of week 10 | • Follow-up 3 (Visit 4): End of week 12
次要结局
未报告次要终点
研究者
Dr Mitaxari Hugar
Karnataka Medical college