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Comparison of effect,safety and cost of sertaconazole cream versus luliconazole cream in patients with dermatophytoses

Comparative assessment of the efficacy, safety and cost effectiveness of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses : A prospective, Randomized , open label, parallel study - CAESCESVLPDPROLPS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010418
Enrollment
64
Registered
2017-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- DERMATOPHYTOSES PATIENTS Health Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: SERTACONAZOLE 2% CREAM: Sertaconazole, an imidazole antifungal agent, inhibits the synthesis of ergosterol, an essential cell wall component of fungi.Sertaconazole has both fungistatic

Sponsors

Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adults between the age group of 18 to 70 years of either gender, with clinical diagnosis and mycological confirmation (positive KOH test) for tinea corporis and tinea cruris infections, will be included in the study. 2)Patient having a Physician global assessment (PGA) composite score of at least 5 will be included in the study. 3)Patient willing to give written informed consent will be included in the study

Exclusion criteria

Exclusion criteria: 1)Patients having clinical diagnosis of tinea infections other than tinea corporis and tinea cruris, 2)Patients having extensive fungal infection, 3)Patients who had received topical or oral antifungal agents upto four weeks prior to the initiation of the study, 4)History of hypersensitivity to study drugs, 5)Immunocompromised patients, 6)Patients having superadded bacterial infection, 7)Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
To Compare the efficacy of sertaconazole (2%) cream versus luliconazole (1%) cream in patients with dermatophytoses by clinical examination with the help of 4 â?? point Physician Global Assessment (PGA) scaleTimepoint: Time duration- 6 week follow up at 4th week and 6th week

Secondary

MeasureTime frame
1)To assess the safety and relapse in patients with dermatophytoses receiving sertaconazole (2%) cream or luliconazole (1%) cream by clinical examination , KOH mount, and monitoring adverse drug events. 2)To assess the cost effectiveness of sertaconazole (2%) cream and luliconazole (1%) cream in patients with dermatophytoses Timepoint: 6th weeks

Countries

India

Contacts

Public ContactDr JAYESH MUKHI

Government medical college, Nagpur

gndakhle@rediffmail.com9850539353

Outcome results

None listed

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