"A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris"
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure.
Study Overview
Brief Summary
Topical antifungal drugs are commonly employed in Tinea corporis/cruris.
Several tertiary centers frequently prescribe luliconazole for its broad spectrum and anti-inflammatory property. It is expensive, and relapse are documented.
There is need of antifungals with diverse modes of action, as well as those that are affordable and less risk of relapse.
Ciclopirox olamine inhibits enzymes necessary for fungal cellular activity. It has additional antibacterial properties which help treating superadded infections.
There are very few studies comparing Luliconazole and ciclopirox olamine in the treatment of Tinea corporis/cruris in India.
Hence this study is undertaken to compare Luliconazole versus ciclopirox olamine in the treatment of Tinea corporis and cruris.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients willing to give informed consent and follow up.
- •Patients of either gender aged between 18-60 years.
- •Patients with mild Tinea corporis or cruris and Positive KOH Test.
Exclusion Criteria
- •Patients with hypersensitivity to study medications.
- •Patients with deep fungal infections.
- •Patients with Tinea unguim, Tinea capitis and Tinea barbae.
- •Psychiatric or emotional disturbance in patients.
- •Diabetic and Immunocompromised patients.
Outcomes
Primary Outcomes
Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure.
Time Frame: 0,2,4 weeks
Clinical response is assessed using investigator global evaluation tool based on signs and symptoms which give score ranging from 1 to 5.Where score 1:Healed(absence of signs and symptoms),
Time Frame: 0,2,4 weeks
score 2:markedly improved greater than 50% clinical improvement, score 3:considerable residual lesion(less than 50% clinical improvement),score 4(no change from baseline),score 5 :deterioration from baseline .Clinical response will be defined as having scores 1 or 2 (healed or markedly improved)
Time Frame: 0,2,4 weeks
Mycological cure is defined by achievement of negative result on KOH mount at the end of the treatment period.
Time Frame: 0,2,4 weeks
Change in Total symptom score.
Time Frame: 0,2,4 weeks
Secondary Outcomes
- Safety is assessed by adverse drug reactions which will be reported in CDSCO form and severity grading will be done.(0,2,4th week)
Investigators
Praveen Panchaksharimath
Bangalore Medical College and Research Institute