Aim: To evaluate and compare the therapeutic effectiveness of topical amorolfine, luliconazole, sertaconazole, and terbinafine in the treatment of tinea corporis and tinea cruris. Materials and Methods: This was a prospective, randomized, open-label, parallel-group study conducted in the Department of Dermatology. Designed as a pragmatic trial, the study aimed to assess the clinical response to commonly used topical antifungal agents in the current dermatophytosis scenario. Clinically diagnosed, immunocompetent adult patients (≥18 years) with localized tinea corporis or tinea cruris, and no history of antifungal therapy in the preceding week, were enrolled.A total of 80 patients were included, with 20 patients allocated to each treatment arm. Eligible participants were assigned to receive one of the following topical agents in a sequential manner: amorolfine 0.25%, luliconazole 1%, sertaconazole 2%, or terbinafine 1%. The same brand of each drug was used consistently throughout the study. Amorolfine and luliconazole were applied once daily, whereas sertaconazole and terbinafine were applied twice daily. Results: The mean age of participants was 34 years (range: 18–70 years), with a male-to-female ratio of 1.1:1 (35 males, 32 females). Thirteen participants were lost to follow-up despite telephonic reminders. Luliconazole demonstrated the greatest improvement in pruritus (mean: 1.47), erythema (mean: 1.53), and scaling (mean: 1.53). In contrast, terbinafine showed the least improvement, with mean values of 0.73 (pruritus), 0.60 (erythema), and 0.67 (scaling). The difference in mean improvement scores for luliconazole was statistically significant for pruritus (P = 0.020) and highly significant for erythema and scaling (P = 0.004 and 0.007, respectively). Based on cumulative improvement in all three parameters, patients were categorized as follows: poor response (score 0–2), moderate response (score 3–4), and good response (score 5–6). In the luliconazole group, 12 patients (66%) demonstrated a good response, which was statistically significant compared to the other groups (P = 0.018, Fisher’s exact test). Conclusion: Luliconazole appears to be more effective than amorolfine, sertaconazole, and terbinafine in the treatment of tinea corporis and cruris. Although classified under the azole group, luliconazole may exhibit fungicidal activity. Further studies involving larger sample sizes are warranted to confirm these findings.
Tinea corporis (commonly known as ringworm of the body) and tinea cruris (jock itch) are prevalent superficial fungal infections caused predominantly by dermatophytes such as Trichophyton and Epidermophyton species. Clinically, these infections typically manifest as well-demarcated, erythematous, annular lesions with raised borders and central clearing, commonly affecting areas such as the trunk, limbs, and groin.
Topical antifungal agents remain the cornerstone of treatment for localized dermatophytoses, providing targeted action with minimal systemic adverse effects. These agents work by disrupting the integrity of the fungal cell membrane or by inhibiting critical enzymatic pathways essential for fungal survival and proliferation. Among the most commonly prescribed topical antifungals are amorolfine, luliconazole, sertaconazole, and terbinafine each characterized by distinct mechanisms of action and pharmacological properties suited to specific fungal species and clinical scenarios.1,2 Amorolfine is a broad-spectrum antifungal agent that inhibits ergosterol synthesis, an essential component of fungal cell membranes. It is effective against dermatophytes, yeasts, and molds. Clinical studies have demonstrated its efficacy in treating tinea corporis and tinea cruris, with high cure rates and good tolerability. Amorolfine's broad antifungal spectrum makes it a valuable option for cases resistant to other topical treatments. Luliconazole is a newer azole antifungal that inhibits fungal lanosterol 14α-demethylase, an enzyme crucial for ergosterol synthesis. It exhibits potent fungicidal activity against various dermatophyte species, including those causing tinea corporis and tinea cruris. Studies have shown luliconazole's efficacy in achieving rapid symptom relief and mycological cure, with low recurrence rates. Its favorable safety profile and convenient once-daily application enhance patient compliance and treatment outcomes.3,4 Sertaconazole is a broad-spectrum imidazole antifungal that inhibits ergosterol synthesis and exerts anti-inflammatory effects. It demonstrates efficacy against dermatophytes, yeasts, and some gram-positive bacteria. Clinical trials have validated its effectiveness in treating tinea corporis and tinea cruris, emphasizing its dual action against fungal infection and associated inflammation. Sertaconazole's anti-inflammatory properties contribute to symptom relief, making it suitable for inflammatory forms of these dermatophyte infections. Terbinafine is an allylamine antifungal agent that disrupts fungal cell membrane function by inhibiting squalene epoxidase, an enzyme crucial for ergosterol biosynthesis. It exhibits fungicidal activity against dermatophytes and is effective in treating tinea corporis and tinea cruris, often requiring shorter treatment durations compared to other topical agents. Terbinafine's rapid onset of action and high cure rates make it a preferred choice for uncomplicated fungal infections of the skin.5,6
It was a prospective, randomized, open-labeled, parallel group study was conducted Department of Dermatology. It was a pragmatic study to assess the therapeutic response to certain topical antifungals in the current scenario of dermatophytosis. Clinically diagnosed healthy adult patients with tineacorporis and tinea cruris requiring topical antifungal therapy were selected for the study. Patients aged 18 years or above with localized tinea corporis or cruris without any form of prior treatment for atleast a week were chosen. Recurrent, steroid modified and partly treated tinea infections were also recruited in order to represent the current scenario. A detailed history including the duration of disease, associated medical conditions, treatment history and family history were taken. An arbitrary sample size of 80 was considered with 20 patients in each category of antifungal was considered. Location of lesion, morphology and symptoms were noted. Scrapings from the edge and/or from the scaly area of the lesions were taken. Potassium hydroxide mount (KOH Mount) followed by direct microscopy was undertaken at the beginning of treatment to confirm the diagnosis but not repeated at the end of treatment since clinical improvement rather than a cure was the primary objective of the study. Consecutive eligible patients were prescribed topical amorolfine (0.25%), luliconazole (1%), sertaconazole (2%) and terbinafine (1%) in a serial order. Same brand of the topical drug was used throughout the period of study. Amorolfine and luliconazole were advised once daily while sertaconazole and terbinafine was twice daily application. They were asked to apply as a thin layer directly to the lesions and also a small area beyond the lesions. Response to treatment was assessed after 3 weeks with no follow-up visit. We evaluated the improvement in the pruritus, erythema and scaling with score 0 for no improvement, score 1 for partial improvement and score 2 for complete improvement. Therapeutic response was statistically evaluated using Kruskal Wallis test and Fishers exact test. Clinical images of consented patients were taken at starting of therapy and at 3 weeks with due care that the patient’s identity was not revealed. Antihistamine tablet levocetirizine 5 mg at bed time was given for 7 days to all patients as an anti-pruritic medication.
Among the total 80 patients, 67 reported at the 3 week follow up. Among them 30 were treatment naive, 16 were topical steroid (with or without antifungal) modified cases, 14 were partially treated with antifungals and 7 had used home remedies prior to the study (Table 1). Mean age of these patients was 34 year with youngest being 18 years and oldest 70 years. Male to female (35 versus 32) ratio was 1.1:1. We had 13 drop outs despite telephonically contacting the patients for follow up. Luliconazole showed best improvement of pruritus (mean-1.47), erythema (mean-1.53) and scaling (mean-1.53). Terbinafine showed the least improvement with mean being 0.73, 0.60, 0.67 for pruritis, erythema and scaling respectively. [Table 2] Difference in the mean values of improvement of luliconazole as compared to the other three drugs was significant for pruritus (P = 0.020) and highly significant for erythema and scaling (P = 0.004 & 0.007). Based on the improvement of all three parameters, we categorized the patients into three groups. [Table 3] Total value of improvement in pruritus, erythema and scaling were calculated and patients were grouped into poor response (total score-0, 1 & 2), moderate response (total score-3 & 4) and good response (total score-5 & 6). A total of 12 patients (66%) in luliconazole group showed good response as compared to the other drugs. These differences in the improvement of patients were statistically significant as compared to other drugs (P = 0.018, Fisher’s exact test).
Table 1: Previous topical treatment
Group |
Naive |
Steroid |
Antifungal |
Others |
Amorolfine |
5 |
8 |
3 |
2 |
Luliconazole |
9 |
3 |
6 |
1 |
Sertaconazole |
8 |
3 |
2 |
2 |
Terbinafine |
8 |
2 |
3 |
2 |
Total |
30 |
16 |
14 |
7 |
Table 2: Comparison between pruritus, erythema & scaling
Parameters |
Group |
N |
Mean |
P Value |
|
Pruritus |
Amorolfine |
18 |
1.06 |
0.020 |
Sig |
|
Luliconazole |
19 |
1.47 |
|
|
|
Sertaconazole |
15 |
1.13 |
|
|
|
Terbinafine |
15 |
0.73 |
|
|
Erythema |
Amorolfine |
18 |
0.89 |
0.004 |
Hs |
|
Luliconazole |
19 |
1.53 |
|
|
|
Sertaconazole |
15 |
1.13 |
|
|
|
Terbinafine |
15 |
0.60 |
|
|
Scaling |
Amorolfine |
18 |
0.83 |
0.007 |
Hs |
|
Luliconazole |
15 |
1.53 |
|
|
|
Sertaconazole |
19 |
1.20 |
|
|
|
Terbinafine |
18 |
0.67 |
|
|
Total |
Amorolfine |
18 |
2.78 |
0.009 |
Hs |
|
Luliconazole |
19 |
4.53 |
|
|
|
Sertaconazole |
15 |
3.47 |
|
|
|
Terbinafine |
15 |
2.00 |
|
|
Table 3: Group comparison of drugs
|
Amorolfine |
Luliconazole |
Sertaconazole |
Terbinafine |
||||
Response |
N |
% |
N |
% |
N |
% |
N |
% |
Poor |
7 |
38.9 |
2 |
10.5 |
3 |
20 |
7 |
46.7 |
Moderate |
7 |
38.9 |
5 |
26.3 |
7 |
46.7 |
7 |
46.7 |
Good |
4 |
22.2 |
12 |
63.2 |
5 |
33.3 |
1 |
6.7 |
Total |
18 |
100 |
19 |
100 |
15 |
100.0 |
15 |
100.0 |
N= Number of Patients |
Topical antifungal therapy is the mainstay in the treatment of dermatophytosis; however increased number of extensive infections in the recent times has been a limiting factor. Newer topical antifungals seem to have certain advantages over the older drugs.6 Dermatologist treating dermatophytosis has less information about the efficacy of the currently available topical therapies. Current epidemic of dermatophytosis is complicated by an increased number of chronic and recurrent dermatophytosis.7 Topical steroid abuse also seems to be a major contributor to the onslaught of extensive and treatment resistant cases.8 There has also been a shift in the dominant pathogen responsible for the infections across India from Trichophyton rubrum to Trichophyton mentagrophytes.9 Thus current circumstances are different than a decade ago and we need more information about the response to the therapeutic agents. We conducted this study in 80 adult patients but only 67 completed the study. There was almost equal number of patients in both genders and the sample represented almost all age groups. Only 30 patients were treatment naive. Others used some form treatment that included topical steroids with or without antifungal (16 patients) or antifungal alone (14) which were boughtover the counter (OTC) or prescribed by the local practicing doctors. We found less OTC drug usage in our patients compared to another study but still it was sizable.10 We found that the topical antifungals were effective in majority of the patients, although variable response was seen. Best response at the end of 3 weeks of topical therapy was shown by luliconazole for all three parameters pruritus, erythema and scaling, and the results were statistically significant. Jerajani et al conducted almost a similar study and found sertaconazole exhibiting better response than luliconazole and terbinafine.3Another study conducted by Choudhary et al showed equal efficacy between sertaconazole and terbinafine.11 Improvement was assessed on the basis of total score and 3 groups were made. Out of which luliconazole had 12 patients with good response followed by sertaconazole (5), amorolfine (4) and terbinafine (1) least. This indicates that luliconazole could be the most effective topical antifungal as compared to theother three currently available drugs. This high efficacy may be due to its low MIC as compared to certain other antifungals for T. rubrum and T. mentagrophytes. There seem to be a poor response to the fungicidal drug terbinafine which could be due to various factors that may include drug resistance.12-15 Strength of this study lies in replicating the current scenario of dermatophytosis in the study by including naïve as well as partially treated or mistreated cases. We compared currently available relatively new molecules whose efficacy is less known in the current Indian scenario. Limitation of the study lies in the recruitment of less number of cases. This is primarily due to lesser availability of suitable cases that require only topical treatment despite a large load of dermatophytosis in the daily dermatological practice. Result obtained in the study needed to be validated with inclusion of large number of cases with a better design that could include blinding of the dispensed drug.
We believe that Luliconazole may score over other 3 topical antifungals, however studies involving larger number is required to confirm these findings. Although it belongs to azole class, it seems to exhibits fungicidal activity. This study also signifies the role of topical antifungal alone in treating limited tinea corporis and cruris, thus boosting the confidence on topical therapy. Newer topical anifungals are more expensive and hence pharmaco-economic analysis should also be considered while prescribing them.Topical antifungal therapies can also have a synergy or additivism with systemic antifungals. Hence topical antifungals are the integral part of management of the glabrous tinea infections.