Introduction

Dermatophytosis is a highly prevalent superficial fungal infection in India, with reported rates ranging from 36.6% to 78.4%. Although topical azoles and allylamines remain standard therapies for localized disease, their effectiveness is limited by the prolonged duration of treatment, suboptimal patient adherence, and a notably high relapse rate. Luliconazole is a topical antifungal agent characterized by strong therapeutic efficacy and good tolerability, while also offering the advantage of a comparatively short treatment duration.

Aim 

To compare the efficacy of topical luliconazole versus topical clotrimazole in tinea corporis and tinea cruris. 

Patient Profile

Patients aged >12 years of either sex clinically diagnosed with localized Tinea corporis or Tinea cruris.

Methods

• Open-labelled randomized comparative study
• The patients (n=104) were randomly allotted to Group 1 or Group 2 
  1. Group 1 (n=50) were advised to apply 1% luliconazole cream over the affected area and 1 inch surrounding that area in a thin layer once daily for 2 weeks
  2. Group 2 (n=50) were advised to apply 1% clotrimazole cream over the affected area & 1 inch surrounding the affected area twice daily for 4 weeks
• Mycological assessment
  1. Direct microscopy using KOH mount was performed at baseline and at every follow‑up visit.
  2. Fungal culture was done at baseline and at the end of treatment.
• Clinical assessments
  1. At each visit, both groups were evaluated for changes in pruritus, erythema, scaling, and papules.
  2. Each parameter was graded on a 4‑point severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
  3. A Global Assessment Score (GAS) was calculated at each follow‑up by summing all four parameter scores.
• Patients were monitored for 4 weeks after completing treatment, with both clinical and mycological evaluations to detect relapse

Primary Outcome

Secondary Outcomes

• Clinical cure comparison: The study compared clinical cure at end of 1 week & at end of treatment between luliconazole & clotrimazole. Clinical cure wasdefined asabsence of erythema, scaling, pruritus & papules with aGlobal Assessment Score ≤ 2.
• Mycological cure comparison: Mycological cure at1 week &end of treatment was assessed in both groups. Mycological cure was defined as anegative KOH microscopy result.
• Relapse comparison: Relapse rates were compared after treatment completion. Relapse was defined asreturn of clinical symptoms during follow‑up accompanied by apositive KOH test.

Results

Figure 1: Mean reduction in scores from baseline mean reduction in scores from baseline to the end of 1 week (P<0.05)

Figure 2: Mean reduction in scores from baseline to the end of 1 week. 

• At Week 1, complete clearance occurred in 22% of patients using luliconazole 1% vs 0% with clotrimazole 1%; the between‑group difference was statistically significant (χ²=10.22, p=0.0014). (Figure 3)
• At the end of treatment, complete clearance was achieved by 98% on luliconazole vs 72% on clotrimazole, again statistically significant (χ²=11.294, p=0.0008) (Figure 3) 

Figure 3: Complete Clearance at Week 1 and End of the treatment 

• Clinical cure at 1 week occurred in 22% with luliconazole and 0% with clotrimazole; by end of treatment, clinical cure was 98% vs 86% (p = 0.065).
• Mycological cure at 1 week: 78% (luliconazole) vs 12% (clotrimazole) (p<0.0001). By end of therapy, 98% vs 80%,(p=0.01) respectively. (Figure 1,2, &4)

Figure 4: Proportion of patients achieving clinical and mycological cure, cured and experienced relapse in both groups

• The relapse rate was much lower in the luliconazole group, indicating better sustained effectiveness.
• Both medications were well tolerated; one hypersensitivity reaction occurred with clotrimazole.

Conclusion

• Luliconazole demonstrated faster clinical and mycological improvement with a shorter, once‑daily regimen and lower relapse rates, offering a convenient and effective option for localized tinea infections. 
• Final clinical cure rates were comparable between treatments, with luliconazole achieving outcomes in a shorter duration.

References

Natl J Physiol Pharm Pharmacol 2019;9;8:756-762.