Dermatophytoses, the commonest fungal infections, occur worldwide. Although not life threatening, they may produce significant symptoms which interfere with the quality of life. They are par­ticularly widespread in tropical countries because of warm and humid climate, crowded living conditions, and other socio-economic factors. 

Despite the advent of new antifungal agents, the treatment remains challenging. Many clinical trials have been conducted for the purpose of searching better drugs, both in terms of effectiveness and safety. Combination of terbinafine 1% cream and butenafine 1% cream; terbinafine hydrochloride 1% cream vs. sertaconazole nitrate 2% cream,  terbinafine hydrochloride 1% cream vs. sertaconazole nitrate 2% cream vs. luliconazole 1%,Whitfield’s ointment + oral fluconazole versus topical 1% butenafine are evaluated in the past. Since amorolfine and sertaconazole have emerged as the newest topical antifungals in the wide plethora of drugs available for combating this notorious dermatosis, the aim of this study is to compare the effectiveness and safety of amorolfine 0.25% cream versus sertaconazole 2% cream in the treatment of limited variety of tinea cruris/corporis. To the best of our knowledge, till date no study comparing the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream has been done in localized tinea corporis and tinea cruris. Our study would also evaluate the cost-benefit ratio and cost-utilization ratio with the two treatment groups.

Our objectives are to evaluate and compare the effectiveness, safety and improvement in quality of life of two arms of the study, viz. amorolfine 0.25% cream versus sertaconazole 2% cream.

All untreated male and non-­pregnant female patients above 18 years of age complaining of acute, symptomatic tinea cruris/corporis with limited involvement i.e. limited to single body region with KOH mount showing positive results (hyphae) will be included. Pregnant or nurs­ing females, patients with diabetes mellitus, malignancy, renal or hepatic dysfunction, those who have received topical antifungal agents within the past week or received systemic antifungal agents within past four weeks and have a history of hypersensitivity to any of the study drugs will be excluded.

This institution-based, randomized, double blind, parallel group, comparative trial will be carried out in a tertiary care hospital of eastern India. Every patient will be given treatment for 4 weeks and followed up till 6th week. Follow-up will be scheduled at two weekely intervals.

The sample size is 30 tinea corporis/cruris patients in each treatment group. This was calculated considering mycological cure of 78.9% with amorolfine cream and 100% with sertaconazole cream, with 80% power and 0.05 probability of Type 1 error, for this parameter. Considering a 10% possible dropout rate, this translated to a recruitment target of approximately 33 subjects per group or 66 subjects overall.

Eligible patients will be randomized into either group A (amorolfine0.25% cream) or group B (sertaconazole 2% cream) with allocation ratio 1:1 as per the randomization sequence. Allocation concealment will be done by sequentially numbered opaque sealed envelope (SNOSE) technique.

After thorough evaluation and collection of skin scraping; the investigator will refer patient to Independent Co-ordinator (IC) who will assign treatment to patients.. The tubes will be painted in opaque white color, kept in an opaque envelope and coded “medication A” and “medication B” by the IC. IC will be responsible for the dispensing the medications as per randomization. Thus both patient and assessor will be blind to the treatment received. . The statistical analysis will be performed by an individual who will be blinded to the treatment arms and would identify the treatment received by the patients in terms of code (group A or group B).

Study procedure:

After obtaining written informed consent form each patient, screening will be done. At screening, patients’ demographic details (age, sex, weight, and height) and detailed medical history (including history of hypersensitivity, other systemic diseases, concomitant medication and previous treatment) will be recorded. Physical examination will include localization, clinical classification and recording of the affected area. Specimens will be taken from the lesion for KOH (potassium hydroxide) 10% wet mount and culture on Sabouraud’s dextrose agar (SDA). Blood will be collected for hematology, biochemical analysis (urea, creatinine, LFT).

Patients in group A will receive amorolfine 0.25% cream twice daily application to the lesions along with oral cetirizine 10 mg once daily at bedtime for 4 weeks. Patients in group B will receive sertaconazole 2% cream twice daily application to the lesions along with oral cetirizine 10 mg once daily at bedtime for 4 weeks. After screening and baseline visit patients in both groups will be followed up at 2^nd, 4^th and 6^th week for efficacy and safety parameters.

Study end points:

Efficacy end points

Primary efficacy end point:

• Clinical cure at 2^nd week, 4^th week and 6^th week.
• Mycological cure at 4^th week and 6^th week and will be defined as negative KOH microscopy and negative culture.
• Global cure (combined mycological and clinical cure). Patients will be classified as cured for this combined variable only if they are mycologically and clinically clear. All other cases will be classified as failures for this particular variable.

Secondary efficacy end point: Assessed at each follow up visit

·         Investigator will clinically assess the lesion and will grade the Clinical improvement  as follows:

o   Grade 0 (Clinical Failure): No improvement.

o   Grade I: Persistence of few papular lesions or erythema with mild to moderate itching.

o   Grade II: Scaly lesions with or without itching.

o   Grade III (Clinical cure): Disappearance of original lesions with or without residual pigmentation

.Safety end points

·         Spontaneously reported adverse events and those elicited by the clinician  at each follow up

·         Routine laboratory investigations: Routine hemogram, random blood sugar, urea, creatinine, liver function tests (LFT). (at baseline and week 4 visit)

Global assessment of safety and efficacy

At the end of treatment and test of cure (week 4), patients as well as the investigator will assess treatment for safety as well as efficacy on the Likert’s five point scale as- poor, fair, good, very good, excellent.

Compliance

The compliance will be assessed by daily diary provided to the patients.

Quality of life

Health outcome will be assessed by using vernacular version of Dermatology Life Quality Index (DLQI) after taking permission from the developer.

Cost per patient cured

To calculate this, cost for acquisition of drugs will be considered.

Other variable

Photograph of target lesion at baseline and each follow up visit.