Consider a 28-year-old construction worker presenting to a dermatology outpatient clinic with itchy, ring-shaped, erythematous lesions in the groin and on the trunk that haven't resolved despite three months of self-applied antifungal cream purchased over the counter. The scenario is neither rare nor straightforward: Tinea cruris and Tinea corporis are among the most common skin infections encountered in clinical practice across tropical and subtropical regions, yet treatment failures are increasing, and the classical pharmacological choices no longer guarantee reliable outcomes [1]. Tinea corporis and Tinea cruris are superficial dermatophytic infections that have collectively shown a marked increase in incidence and a notable shift in epidemiological pattern across tropical settings over the past decade [2]. They are caused predominantly by species of Trichophyton, particularly Trichophyton rubrum and Trichophyton mentagrophytes, with the former accounting for the majority of infections globally [3]. In India, the epidemiological profile has shifted considerably over the past decade. What was once a condition responding reliably to short-course azole therapy has increasingly become a therapeutic challenge, with Trichophyton indotineae-a species demonstrating intrinsic resistance to terbinafine and reduced susceptibility to some azoles-emerging as a clinically relevant pathogen across the subcontinent [4]. This epidemiological transformation has been documented across multiple dermatology centres in northern, western, and central India, with reports indicating that T. mentagrophytes-including T. indotineae genotypes-now accounts for a growing proportion of isolates from patients presenting with chronic or relapsing dermatophytosis [16]. The standard treatment for Tinea corporis and Tinea cruris has historically relied on topical antifungal agents, with systemic therapy reserved for extensive, recalcitrant, or immunocompromised presentations. Among topical agents, azoles such as clotrimazole (1%), miconazole (2%), and ketoconazole (2%) have long been first-line choices, supported by decades of clinical use and a well-characterised safety profile [5]. Allylamines- particularly terbinafine 1% cream-offer a fungicidal mechanism of action, acting by inhibiting squalene epoxidase and disrupting ergosterol biosynthesis at an earlier step than azoles; this renders them more rapidly effective in many dermatophytic infections. However, mounting evidence from India and other endemic regions suggests that indiscriminate use of topical antifungals, combined with sub-therapeutic dosing and poor treatment adherence, may be accelerating the development of reduced drug susceptibility in clinical dermatophyte isolates [6]. Newer azole compounds, including luliconazole 1% cream, have attracted attention for their potent in-vitro activity against Trichophyton species, improved skin penetration due to their formulation as an enantiomerically pure compound, and once-daily application convenience [7]. Comparative clinical data on these three agents-clotrimazole, terbinafine, and luliconazole-in the context of Indian patients with Tinea corporis and Tinea cruris remain limited and methodologically varied. Several earlier investigations focused on individual efficacy without direct head-to-head comparisons under the same clinical conditions [8]. Many single-arm or open-label studies in Indian cohorts have reported cure rates ranging widely (50-90%) depending on the agent, duration of treatment, and whether mycological confirmation was used as part of the endpoint, making cross-study comparisons unreliable [17]. Given the documented rise in treatment-resistant dermatophytosis in India, a carefully designed comparative research examining clinical and mycological outcomes simultaneously-rather than relying on clinical response alone-is both timely and practically important [9]. Mycological cure, assessed by KOH microscopy and fungal culture negativity, provides an objective measure of treatment success that is less subject to patient-reported symptom variability. Clinical cure, measured through composite symptom scoring, captures the patient's lived experience of improvement. Combining both endpoints offers a balanced and clinically meaningful picture of antifungal efficacy [10]. The composite scoring system used in this research captures erythema, scaling, pruritus, and lesion margin indistinctness on a 0-3 scale each (total: 0-12), providing sensitivity to both early and later changes in the clinical picture. Clinico-mycological profiling of infected patients at baseline-including species identification and documentation of prior treatment history-is also important to contextualise cure rates and identify factors associated with poorer outcomes, particularly in a population where a high proportion have already attempted self-treatment [18]. The research also addresses the clinical diversity of presentation: Tinea corporis can appear on the trunk, limbs, or face, while Tinea cruris tends to affect the inguinal and perineal areas, with occasional extension to the inner thighs and buttocks [2]. Whether infection site influences response to a given topical agent is an important secondary question, as anatomical factors- moisture levels, skin occlusion, and friction-at the groin may reduce drug bioavailability or promote reinfection compared to the more accessible body sites [11]. This sub-analysis forms part of the present research. This research was carried out to compare the clinical and mycological efficacy of clotrimazole 1%, terbinafine 1%, and luliconazole 1% topical creams in confirmed cases of Tinea corporis and Tinea cruris at 4 weeks. Secondary objectives included comparing adverse event profiles across the three agents and assessing whether infection site influenced treatment outcomes. The results aim to provide evidence-based guidance for the selection of topical antifungal agents in a tertiary care dermatology setting in central India, where the pattern of dermatophyte species and their susceptibility profiles may differ from global averages.

This randomised, open-label, three-arm comparative research was conducted at the Dermatology Outpatient Department of Index Medical College Hospital and Research Centre, Indore, Madhya Pradesh, India-a NABH-and NABL-accredited tertiary care institution serving patients from Indore and a wide catchment area spanning approximately 12 districts of Madhya Pradesh. Indore is the most populous city in Madhya Pradesh and experiences a hot, humid climate for much of the year, conditions that are known to favour the proliferation of dermatophytes and are consistent with the high burden of tinea infections seen in this OPD. The research was conducted from March 2021 to February 2022, encompassing a total span of approximately 12 months. All participants were recruited through the dermatology OPD during routine clinical attendance; no inpatient referrals or advertisement-based recruitment was used. A total of 240 participants aged 18-65 years with clinically and mycologically confirmed Tinea corporis, Tinea cruris, or both were enrolled. Inclusion criteria required: active lesions with the characteristic annular, centrifugally spreading pattern with erythema and scaling; positive KOH microscopy from skin scrapings taken from the active border of the lesion; and willingness to attend follow-up visits at 2 and 4 weeks. Exclusion criteria included: use of any topical or systemic antifungal within the preceding four weeks; immunosuppressive conditions (including poorly controlled diabetes mellitus with HbA1c > 9%, HIV infection, or organ transplantation); concurrent Tinea unguium or Tinea capitis; pregnancy or lactation; and known hypersensitivity to any azole or allylamine compound. Skin scrapings were collected from the active erythematous border of lesions using a sterile scalpel blade. KOH preparation (20% KOH) was performed on-site and examined under a binocular microscope at 10× and 40× magnification. Samples were additionally inoculated on Sabouraud's dextrose agar with chloramphenicol and incubated at 28 °C for four weeks for species identification. Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum were identified by standard morphological criteria. Methods Following confirmation of diagnosis, participants were randomised to one of three treatment groups using a sealed-envelope method based on a computer-generated randomisation list prepared by a biostatistician independent of the clinical team. Group A (n = 80) received clotrimazole 1% cream applied twice daily; Group B (n = 80) received terbinafine 1% cream applied once daily; and Group C (n = 80) received luliconazole 1% cream applied once daily. All creams were applied to the lesion and extended approximately 2 cm beyond the active border. Participants were instructed to continue treatment for four weeks regardless of early symptom resolution and to avoid sharing towels or clothing during the research period. Clinical assessment at baseline, 2 weeks, and 4 weeks used a composite score evaluated across four parameters: erythema (0-3), scaling (0-3), pruritus (0-3), and margin indistinctness (0-3); total composite score range 0-12. Assessments were performed by a blinded assessor not involved in treatment allocation. KOH microscopy was repeated at 4 weeks; fungal culture was repeated at 4 weeks. Mycological cure was defined as both negative KOH and negative fungal culture at 4 weeks. Combined clinical and mycological cure required composite score of 0 and mycological cure at 4 weeks. Adverse events were assessed at each follow-up visit using a structured checklist including: local burning, local erythema, dryness, peeling, and pruritus at the application site. Severity was graded as mild (not interfering with daily activities), moderate (interfering with daily activities), or severe (requiring treatment discontinuation). Statistical analysis was carried out using IBM SPSS Statistics version 26.0 (IBM Corp., USA). Cure rates were compared between groups using chi-square tests with post-hoc pairwise comparison (Bonferroni correction). Composite score change from baseline was assessed using repeated-measures ANOVA. Sub-group analysis by infection site was performed separately. The significance level was p < 0.05. The sample size of 80 per group was calculated to detect a difference in cure rate of ≥15 percentage points between groups at 80% power and α = 0.05, based on a two-sided chi-square test, assuming a cure rate of 60% in the clotrimazole group derived from published Indian data. An independent biostatistician performed the sample size calculation and prepared the randomisation list. research duration: March 2021-February 2022. location: Dermatology OPD, Index Medical College Hospital and Research Centre, Indore, Madhya Pradesh. ethics approval: Institutional Ethics Committee, IMCHRC, Indore (IEC/IMCHRC/2021/034; Approved: 10 February 2021). Trial registration: Clinical Trials Registry-India (CTRI/2021/03/031722). ethical considerations The research was conducted in conformance with the ethical principles of the Declaration of Helsinki and the Indian Council of Medical Research (ICMR) guidelines for biomedical research on human subjects. Ethical clearance was obtained from the Institutional Ethics Committee, Index Medical College Hospital and Research Centre, Indore (IEC/IMCHRC/2021/034; Approval date: 10 February 2021), and the research was prospectively registered with the Clinical Trials Registry-India (CTRI/2021/03/031722) before participant enrolment commenced. All participants provided written informed consent in their preferred language-Hindi or English-before inclusion. The consent process included a detailed explanation of the research purpose, the three treatment options, follow-up requirements, and the right to withdraw at any time without impact on routine medical care. Participant data were coded and stored in a secure, access-restricted electronic database. Clinical and mycological findings were reported in aggregate without individual identifiers. Participants reporting adverse events at any follow-up visit were managed appropriately by the clinical team and, where necessary, treatment was discontinued without penalty to their participation in safety follow-up assessments. participant characteristics The 240 enrolled participants had a mean age of 32.6 ± 9.8 years (range: 18-62 years), and males comprised 64.2% (n = 154) of the cohort. Distribution across treatment groups was balanced, with no statistically significant differences in age, sex, infection site, or baseline composite score between groups (p > 0.05 for all parameters). Tinea cruris was more prevalent than Tinea corporis in the cohort (56.3% vs. 31.2%); the remaining 12.5% had concurrent Tinea corporis and Tinea cruris. Trichophyton rubrum was the most commonly isolated organism (62.5%), followed by T. mentagrophytes (29.2%) and E. floccosum (8.3%). The mean disease duration before enrolment was 4.8 ± 3.1 months. Prior use of over-the-counter topical preparations-not meeting the exclusion criteria for duration-was reported by 47.1% of participants, suggesting that a considerable proportion had already attempted self-treatment before seeking tertiary care. The mean baseline composite clinical score across all three groups was 7.9 ± 1.8 out of 12, indicating moderate disease severity at enrolment.

At the 4-week endpoint, combined clinical and mycological cure rates differed significantly across the three treatment groups (p = 0.004), establishing luliconazole 1% cream as the most effective agent and clotrimazole 1% cream as the least effective. Across all participants, mycological clearance by KOH negativity correlated closely with clinical cure, supporting the combined endpoint as the most robust measure of treatment success. The radar chart in Figure 1 shows the mean composite clinical score across the five evaluated parameters at baseline and at 4 weeks for each treatment group. Figure 1 demonstrates that luliconazole 1% (Group C) produced the greatest absolute reduction across all five assessed parameters at 4 weeks, while clotrimazole 1% (Group A) showed the least reduction. Terbinafine 1% (Group B) produced intermediate improvement. The greatest between-group differences at 4 weeks were seen in the erythema and margin indistinctness parameters, suggesting that the two better-performing agents produced more complete resolution of inflammatory and marginal features. NS = not significant; SD = standard deviation; p-values between groups at each time point by one-way ANOVA. KOH negativity at 4 weeks was achieved in 85.0% of Group C participants (luliconazole), compared to 78.8% in Group B (terbinafine) and 62.5% in Group A (clotrimazole). Fungal culture negativity rates followed a similar pattern: 78.8% (luliconazole), 71.3% (terbinafine), and 55.0% (clotrimazole). The difference in culture negativity rates between Group C and Group A was statistically significant (p = 0.002). Figure 2 shows the mycological outcome data. Subgroup analysis by infection site (Figure 3) revealed that combined cure rates were consistently lower in Tinea cruris compared to Tinea corporis across all three treatment groups. The difference was most pronounced in the clotrimazole group (Tinea cruris: 52.4% vs. Tinea corporis: 63.2%) and was smallest in the luliconazole group (Tinea cruris: 78.9% vs. Tinea corporis: 83.7%), suggesting that the site-level efficacy gap is attenuated with more potent agents. Table 2: Combined clinical and mycological cure rates, individual endpoint cure rates, and adverse events at 4 weeks by treatment group Outcome Measure Group A Clotrimazole 1% (n=80) Group B Terbinafine 1% (n=80) Group C Luliconazole 1% (n=80) p-value Combined cure (%) 57.5% 73.8% 81.3% 0.004 KOH negativity (%) 62.5% 78.8% 85.0% 0.003 Culture negativity (%) 55.0% 71.3% 78.8% 0.002 Clinical score = 0 (%) 48.8% 65.0% 73.8% 0.006 Local burning (%) 7.5% 5.0% 8.8% 0.641 (NS) Local peeling (%) 3.8% 6.3% 3.8% 0.692 (NS) Treatment discontinuations 0 (0%) 0 (0%) 0 (0%) N/A NS = not significant. Combined cure requires both composite clinical score = 0 and mycological cure at 4 weeks. Figure 4 illustrates the mechanism of action of the three antifungal agents at the fungal cell membrane level, explaining the pharmacological basis for their differing clinical efficacy. Extended Comprehensive Interpretation The data collectively establish a clear hierarchy of efficacy: luliconazole 1% > terbinafine 1% > clotrimazole 1% in terms of combined clinical and mycological cure at 4 weeks. The 23.8 percentage-point difference in combined cure rates between luliconazole and clotrimazole is clinically meaningful, particularly given the context of rising treatment failure with older azole agents in India. The once-daily dosing and superior stratum corneum penetration of luliconazole, combined with its broader inhibitory spectrum against dermatophyte-specific CYP51 isoforms, appear to translate into a measurable clinical advantage in this cohort. Luliconazole also maintained a narrower efficacy gap between Tinea corporis and Tinea cruris compared to the other two agents, suggesting a degree of formulation robustness across anatomically challenging sites. Safety Considerations All three topical antifungal agents used in this research demonstrated favourable local tolerability profiles over the 4-week treatment period. Local adverse effects were mild, transient, and did not necessitate treatment discontinuation in any participant. The most frequent event was mild burning or stinging at the application site, reported in up to 8.8% of the luliconazole group; this is consistent with known formulation-related local effects reported in published safety data. Mild peeling or dryness occurred at a slightly higher rate in the terbinafine group (6.3%), attributable to the keratolytic activity characteristic of allylamines at skin surfaces. No participant in any group experienced systemic adverse events over the 4-week period. Participants were monitored at 2 and 4 weeks using a structured adverse event checklist, and any reported event was graded for severity and managed accordingly. The safety profiles of the three agents were broadly equivalent, indicating that therapeutic selection should be driven by efficacy and dosing convenience rather than tolerability concerns. Future research with extended follow-up periods should include formal assessment of relapse and rebound dermatophytosis following cessation of topical therapy, as part of a comprehensive post-treatment safety and efficacy monitoring protocol.

The primary finding of this research-superior combined clinical and mycological cure rates with luliconazole 1% cream compared to terbinafine 1% and clotrimazole 1% at 4 weeks-is consistent with an emerging body of evidence that positions newer enantiomerically pure azoles as the most effective topical option for dermatophytosis in Indian patients. Three Indian multicentre investigations published between 2019 and 2022 reported luliconazole cure rates for Tinea corporis and Tinea cruris ranging from 76-84%, aligning with the 81.3% combined cure rate observed here [12]. Similarly, the terbinafine 1% cure rate of 73.8% corresponds to rates reported in earlier Indian cohorts from comparable tertiary care settings [13]. Prior investigations comparing azoles and allylamines have generally favoured terbinafine for shorter-duration therapy due to its fungicidal mechanism of action. The in-vitro superiority of terbinafine over clotrimazole against T. rubrum is well-established [14]. But what hasn't always been clear from existing literature is where luliconazole fits relative to terbinafine in a head-to-head real-world comparison. The present data suggest that luliconazole's advantage over terbinafine- approximately 7-8 percentage points in combined cure rate-is consistent but modest. In settings where terbinafine resistance mediated by SQLE gene mutations is suspected or where T. indotineae is prevalent, luliconazole may offer a meaningful alternative with its different molecular target [15]. One area of disagreement with some earlier literature concerns the performance of clotrimazole in short-duration topical therapy. Published reviews of antifungal therapy options, drawing on data from earlier clinical trials conducted before the emergence of resistant dermatophyte strains, have cited clinical cure rates of 70-80% for clotrimazole 1% applied twice daily for 4 weeks in uncomplicated Tinea corporis [5]. The considerably lower combined cure rate of 57.5% observed in the present research may reflect a genuine shift in Trichophyton susceptibility at the study site, the higher rigour of mycological confirmation as part of the composite endpoint, or the inclusion of Tinea cruris-a site where all agents performed less well-in the overall cure rate calculation. Each of these possibilities is plausible and not mutually exclusive; only concurrent susceptibility testing of clinical isolates would allow definitive attribution. This discrepancy warrants further investigation through prospective susceptibility testing of dermatophyte isolates alongside clinical trials. A plausible explanation for the site-specific difference in cure rates-lower in Tinea cruris than Tinea corporis across all agents-relates to drug bioavailability in the inguinal microenvironment. The groin site, characterised by higher moisture levels, skin occlusion, and mechanical friction, is more challenging for sustained topical drug contact compared to exposed trunk or limb skin. Recommending moisture-wicking clothing, antifungal dusting powder use, and treatment of concurrent tinea pedis (a common reservoir) may improve outcomes in Tinea cruris cases regardless of the topical agent selected. The broader implications of this research extend to the current antifungal prescribing landscape in India. As treatment failures with older agents accumulate, newer topical agents supported by comparative clinical data offer a more defensible basis for prescription choices. That said, real-world antifungal selection must also account for cost, accessibility, and patient compliance with dosing schedules-factors not formally assessed in the present research but relevant to any prescribing recommendation intended for use across socioeconomic strata.

The main contribution of this research is a head-to-head comparative assessment of three topical antifungal agents-clotrimazole 1%, terbinafine 1%, and luliconazole 1%-under uniform clinical and mycological evaluation criteria in a well-characterised patient cohort with mycologically confirmed Tinea corporis and Tinea cruris at a tertiary care centre in central India. The inclusion of combined clinical and mycological cure as the primary efficacy endpoint, rather than clinical response alone, adds objectivity to the outcomes and enables clearer differentiation between agents whose clinical response rates might otherwise appear more similar than their mycological outcomes reveal. Conducting this comparison in a setting of clinically confirmed infection, with blinded outcome assessors and a randomised allocation design, raises the internal validity of the findings and allows the results to contribute meaningfully to the comparative efficacy literature on topical antifungals in Indian patients. The supporting evidence from this research points consistently in one direction: luliconazole 1% cream achieved the highest combined cure rate (81.3%), with KOH negativity in 85.0% and culture negativity in 78.8% of treated participants at 4 weeks. Terbinafine 1% cream produced intermediate results-combined cure: 73.8%, KOH negativity: 78.8%, culture negativity: 71.3%-while clotrimazole 1% cream showed the lowest overall performance, with a combined cure rate of 57.5% and culture negativity of just 55.0%. The inter-group difference in combined cure rates was statistically significant (p = 0.004), and the ranking of agents was consistent across both Tinea corporis and Tinea cruris subgroups, with the groin site producing modest but consistent reductions in cure rates for all three agents. All three agents were safe and well-tolerated, with no serious adverse events and no treatment discontinuations over the 4-week course. The field significance of these findings is considerable. Dermatophytosis is the most common superficial fungal infection in tropical countries, and the treatment landscape in India has been complicated by rising rates of treatment failure, partial azole resistance, and the emergence of T. indotineae as a clinically relevant pathogen. Against this background, comparative clinical data from Indian tertiary care centres-rather than extrapolation from investigations conducted in non-endemic settings-provide the most relevant evidence base for prescribing decisions. The present research contributes to this evidence base by demonstrating that both luliconazole 1% and terbinafine 1% outperform clotrimazole 1% in this central Indian cohort, with luliconazole showing a further advantage in combined cure rate. These findings support the case for reconsidering clotrimazole as the routine first-choice topical agent in tertiary care settings, at least until susceptibility data confirm that the local Trichophyton population remains fully sensitive. Several open questions remain for future investigation. First, this research did not assess antifungal susceptibility testing on isolated fungal strains; future research should correlate in-vitro minimum inhibitory concentrations (MICs) with clinical outcomes to understand whether observed treatment failures are linked to reduced drug susceptibility or other patient-level factors. Second, the follow-up period was limited to 4 weeks; relapse rates at 8 and 12 weeks following treatment cessation were not assessed, and whether the initial cure advantage of luliconazole translates into lower relapse rates is unknown and warrants a longitudinal follow-up research. Third, the cost-effectiveness of luliconazole relative to the older agents has not been formally evaluated in the Indian health system context-given that cost is a major determinant of treatment access and patient compliance in a largely out-of-pocket expenditure model, a pharmacoeconomic analysis would strengthen the prescribing case. Fourth, larger multicentre research including mycological susceptibility profiling of dermatophyte isolates across different regions of India would provide a more complete picture of the relationship between species prevalence, resistance patterns, and clinical outcomes in this important and growing public health problem.

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