Luliconazole
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Luliconazole: From Tinea Infections to Pityriasis Versicolor
One-Sentence Summary
Luliconazole is a topical imidazole antifungal, originally used for tinea pedis, tinea corporis and other dermatophyte infections. The TxGNN model predicts it may be effective for pityriasis versicolor, with 1 registered clinical trial (not yet recruiting) and 2 publications currently supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Tinea pedis, tinea corporis, tinea infection, dermatophytosis of groin and perianal area (the Singapore licence has no indication text on file) |
| Predicted New Indication | Pityriasis versicolor |
| TxGNN Prediction Score | 99.13% |
| Evidence Level | L3 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this report. Based on known information, luliconazole is a topical imidazole antifungal. Imidazoles inhibit lanosterol 14-alpha-demethylase, an enzyme needed to make ergosterol, a key component of the fungal cell membrane. Its efficacy in dermatophyte infections has been established, and mechanistically it may be applicable to pityriasis versicolor.
Pityriasis versicolor is a superficial skin infection caused by Malassezia yeasts, which are also susceptible to azole antifungals. Published in vitro work describes luliconazole as active against dermatophytes, Candida and Malassezia. The link is therefore biologically consistent. Note that this reasoning is inferred from the drug class rather than from confirmed mechanism data compiled for this report.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07333170 | Phase 4 | Not yet recruiting | 86 | Head-to-head comparison of luliconazole 2% cream vs ketoconazole 1% cream in pityriasis versicolor. Planned for 2026-02 to 2026-11. No results yet. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27559523 | 2016 | Comparative clinical study (described as a prospective, open, randomized controlled trial in the title) | Indian Dermatology Online Journal | Compared topical ketoconazole with topical luliconazole in pityriasis versicolor at a tertiary hospital in eastern India. No abstract was available, so results could not be summarised. |
| 29198426 | 2018 | In vitro study | Journal de Mycologie Médicale | Luliconazole inhibits sterol 14-α-demethylase and has broad antifungal activity, including against Malassezia. The study itself tested Candida strains. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16428P | LUCONAC EXTERNAL SOLUTION FOR NAILS 5% w/w | Solution | Not listed |
Note: the only registered product is a 5% nail solution (manufacturer: Sato Pharmaceutical Co., Ltd.). It is not a cream formulation like the one being tested in the pityriasis versicolor trial.
Safety Considerations
Please refer to the package insert for safety information.
No drug-interaction records were found for luliconazole.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The mechanism is consistent with Malassezia susceptibility to azoles, and a head-to-head trial against ketoconazole is registered. The only published comparative study has no abstract available and its design is not confirmed, and the registered trial has no results yet. Evidence is therefore moderate rather than strong.
To proceed, the following is needed:
- Obtain the results of PMID 27559523 and confirm its design and outcomes
- Follow the results of NCT07333170 once completed
- Detailed mechanism of action data (MOA)
- Package insert warnings and contraindications from the HSA website
- Confirm that a cream formulation suitable for this indication is available in Singapore, since the only registered product is a nail solution
Other Predicted Indications (Brief Note)
- Superficial mycosis (L3) overlaps heavily with the existing dermatophyte indications. It is better viewed as an extension within the same disease family than as true repurposing. No registered trials were found.
- Cutaneous candidiasis (L4) has only preclinical support (in vitro and rat model data). No human trials were found.
- Majocchi granuloma, tinea profunda, and dermatophytosis of scalp or beard (L4) have only case-level or indirect evidence. Topical penetration into hair follicles and deep tissue is a limiting factor.
- Endothrix and ectothrix infectious disease (L5) are supported by model prediction only.
- Echinococcus granulosus infection and ophthalmic herpes zoster (L5) are likely network artifacts. Luliconazole has no known antiparasitic or antiviral mechanism.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.