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

Phase 4

Completed

Conditions: Other specified local infections of the skin and subcutaneous tissue,

Registration Number: CTRI/2017/11/010418

Lead Sponsor: Government Medical College

Brief Summary: **Thesis/Dissertation protocol-** Superficial mycotic infection such asâ€˜Dermatophytosesâ€™ is an extremely common infection occurring throughout theworld with a reported incidence of 20% in USA.The disease is caused bydermatophytes belonging to genera of Trichophyton, Microsporum and Epidermophyton.The fungal infections of the skin and its appendages are more common intropical countries like India due to environmental factors like heat (summer)and humidity (monsoon).However in India, the most commonly occurringclinical type of dermatophytoses for adults includes, tinea corporis (36-59%)and tinea cruris (12-27%). Imidazoles, allylamines and triazoles are mosteffective agents for dermatophytoses. Topical daily antifungal therapy usuallyinvolves imidazoles (namely, *Sertaconazole* and *Luliconazole*) andallylamines (*Terbinafine*). Thecomparative effectiveness and safety of luliconazole and sertaconazole remainsunclear and well-designed head-to-head trials of newer antifungals are warrantedto establish these agents relative efficacy in treating tinea infections.Sothis study is planned to compare sertaconazole with luliconazole in patientswith dermatophytoses.

**complete study plan-**

**Day 0-**Written informed consent , baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment) -Drug given (either sertaconazole 2% cream or luliconazole 1% cream)

**End of treatment-**baseline investigation (10% KOH) and assessment of scale (PGA-Physician Global Assessment) **After 2 weeks of end of treatment-**baseline investigation (10% KOH) , assessment of scale (PGA-Physician Global Assessment),safety and cost effectiveness

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 64

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) scale	Time duration- 6 week \| follow up at 4th week and 6th week

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): DERMATO-VENEREO-LEPROLOGY DEPARTMENT,GOVERNMENT MEDICAL COLLEGE ,NAGPUR
🇮🇳
Nagpur, MAHARASHTRA, India
DERMATO-VENEREO-LEPROLOGY DEPARTMENT,GOVERNMENT MEDICAL COLLEGE ,NAGPUR
🇮🇳Nagpur, MAHARASHTRA, India
Dr ASHISH GUPTA
Principal investigator
7057189408
dr.ashish1489@gmail.com