To compare effect of Luliconazole cream versus Ciclopirox olamine cream in Tinea infection

"A Comparative study to evaluate the efficacy and safety of topical Luliconazole versus topical Ciclopirox olamine among patients with Tinea corporis/cruris" - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063613

Enrollment

Registered

2024-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Topical luliconazole 1% cream: Sufficient quantity of the cream should be applied at the site of infection including 1 cm of normal skin twice daily for four weeks. Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients willing to give informed consent and follow up. 2)Patients of either gender aged between 18-60 years. 2)Patients with mild Tinea corporis or cruris and Positive KOH Test.

Exclusion criteria

Exclusion criteria: 1)Patients with hypersensitivity to study medications. 2)Patients with deep fungal infections. 3)Patients with Tinea unguim, Tinea capitis and Tinea barbae. 4)Psychiatric or emotional disturbance in patients. 5)Diabetic and Immunocompromised patients.

Design outcomes

Primary

Measure	Time frame
Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure. 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), 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) Mycological cure is defined by achievement of negative result on KOH mount at the end of the treatment period. Change in Total symptom score. Timepoint: 0,2,4 weeks	—

Measure

Time frame

Primary effectiveness is assessed based on percentage of patients achieving complete clearance. Complete clearance is defined as achieving both clinical response and mycological cure. 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), 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) Mycological cure is defined by achievement of negative result on KOH mount at the end of the treatment period. Change in Total symptom score. Timepoint: 0,2,4 weeks

—

Secondary

Measure	Time frame
Safety is assessed by adverse drug reactions which will be reported in CDSCO form and severity grading will be done.Timepoint: 0,2,4th week	—

Countries

India

Contacts

Public ContactPradeep

Bangalore Medical College and Research Institute

katakepradeep11@gmail.com9980204261

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026