"A study to compare two drugs Seratconazole versus Luliconacole for improvement of symptoms and to compare the side effects"

Not yet recruiting

Conditions: Local infection of the skin and subcutaneous tissue, unspecified, (2) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,

Brief Summary: Topical antifungals are considered as thefirst-line therapy for superficial dermatomycoses because of their efficacy andlow potential for systemic adverse effects. These drugs are available invarious formulations to facilitate penetration and improve efficacy. The differentclasses of topical antifungal drugs for dermatophytosis include polyenes, azoles, and allylamine/benzylamines.

Luliconazole has animidazole moiety in the ketene dithioacetate structure augments its actionagainst filamentous fungi while maintaining the broad spectrum of antifungal activity. The other imidazole, Sertaconazole, withits broad-spectrum antifungal activityhas additionalanti-inflammatory and antipruritic effects because of which increasedcompliance is seen amongst patients. Sertaconazole is reported tohave higher lipophilicity and greater retention of drug in the stratum corneumleading to greater mycological cure and faster clinical cure rates with less relapserate.

In the Indian population, data onhead-to-head comparisons of these drugsare scanty. Hence the present study isundertaken to evaluate the efficacy and assess the safety of Sertaconazoleversus Luliconazole in patients with mild tinea corporis at our tertiary care center.

Recruitment & Eligibility

Inclusion Criteria

Patients willing to give written informed consent and willing for follow up 2.
Patients of either gender, aged 18- 60 years 3.
Patients with mild tinea corporis lesions (<3% of body surface area)3 confined to limbs and trunk with only KOH mount report positive and treatment-naive.

Exclusion Criteria

Patients not willing to give informed consent and not willing for follow up 2.
Patients with deep fungal infections 3.
Patients with tinea infection on other parts of the body (scalp, groin, feet, nails, hands, and toes ) 4.
Cases of dermatophytosis with a secondary bacterial infection 5.
Diabetic and immuno-compromised patients 6.
Pregnant and lactating mothers 7.
Patients with a history of hypersensitivity to azole and allylamine groups 8.
Patients on oral antifungal medications.

Primary Outcome Measures

Name	Time	Method
Efficacy is assessed based on clinical cure and mycological cure of tinea lesion.	0,4,6 weeks
A clinical cure is assessed based on symptoms and signs of tinea lesions namely	0,4,6 weeks
pruritis, erythema, and desquamation/scaling which are graded depending on intensity. Pruritus	0,4,6 weeks
by visual analogue score, Erythema by clinicianâ€™s erythema assessment score, Scaling is	0,4,6 weeks
assessed by the clinicianâ€™s assessment score will be recorded and analyzed at the	0,4,6 weeks
end of the 4th week and at the end of the 6th week.	0,4,6 weeks
A mycological cure will be assessed by KOH Mount at the baseline (1st visit) and	0,4,6 weeks
at the end of the 6th week.	0,4,6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety is assessed by Adverse drug reactions which will be reported in CDSCO	form and severity grading will be done.

Locations (1): Victoria Hospital
🇮🇳
Bangalore, KARNATAKA, India
Victoria Hospital
🇮🇳Bangalore, KARNATAKA, India
Yuvarani R
Principal investigator
6383240700
yuvaraniramamoorthy97@gmail.com