Sertaconazole
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Sertaconazole: From Tinea Pedis to Dermatophytosis of the Groin and Perianal Area
One-Sentence Summary
Sertaconazole is a topical imidazole antifungal, originally used to treat tinea pedis (athlete's foot). The TxGNN model predicts it may be effective for dermatophytosis of the groin and perianal area (tinea cruris), but no clinical trials or publications specific to this indication were found. Its neighbouring predictions, particularly tinea corporis, are better supported, with 19 publications including several randomized comparative studies.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Tinea pedis |
| Predicted New Indication | Dermatophytosis of groin and perianal area |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold |
Note: The top-ranked prediction has no supporting studies. The second-ranked prediction, tinea corporis (score 99.94%, Evidence Level L2), is the best-supported candidate, with a recommendation of Proceed with Guardrails. It is discussed below for context.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, sertaconazole is an imidazole antifungal. Imidazoles inhibit ergosterol synthesis, an essential component of the fungal cell membrane. Sertaconazole also has a benzothiophene ring that may add direct membrane-damaging effects.
Tinea pedis and tinea cruris are both superficial infections caused by dermatophytes, often the same species. A drug that works against the fungi causing tinea pedis would plausibly work against those causing tinea cruris, so the prediction is mechanistically sensible.
However, the data compiled for this report contain no trials or literature specific to tinea cruris. Support comes only from the high model score and the approved tinea pedis use. Separate publications that cover tinea corporis and tinea cruris together (for example, PMID 24249898) were found under the tinea corporis prediction. They may be relevant to the groin indication as well.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
No literature was found for the top-ranked indication (groin and perianal dermatophytosis). The table below shows the most relevant publications for the closely related tinea corporis prediction, some of which also cover tinea cruris.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24249898 | 2013 | RCT | Indian J Dermatol | Terbinafine 1% cream vs sertaconazole 2% cream in tinea corporis and tinea cruris |
| 35068526 | 2021 | RCT | Indian J Dermatol | Eberconazole vs sertaconazole in localised tinea infection |
| 18039020 | 2007 | RCT | Am J Clin Dermatol | Sertaconazole 2% solution vs cream in tinea corporis, tinea pedis interdigitalis, or corresponding candidosis |
| 25386455 | 2014 | RCT | J Clin Diagn Res | Sertaconazole vs clotrimazole in tinea corporis |
| 24249897 | 2013 | RCT | Indian J Dermatol | Sertaconazole 2% vs butenafine 1% in tinea infections of skin; efficacy, safety and cost |
| 17121064 | 2006 | RCT | Cutis | Two vehicle-controlled studies of sertaconazole 2% cream in tinea pedis (588 enrolled) |
| 19275277 | 2009 | Review | Drugs | Review of sertaconazole in superficial mycoses; EU indications include tinea corporis, tinea cruris and tinea pedis |
| 15954850 | 2005 | Review | Expert Rev Anti Infect Ther | Updated review of sertaconazole as a topical antifungal |
| 27502503 | 2017 | Review | Mycopathologia | New antifungal agents and formulations against dermatophytes |
| 28066103 | 2016 | Randomized study | Indian J Pharmacol | Sertaconazole vs terbinafine in localized dermatophytosis (tinea corporis or cruris) |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN11905P | ZALAIN VAGINAL SUPPOSITORY 300 mg | Suppository | Not available |
| SIN10933P | ZALAIN CREAM 2% | Cream | Not available |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked indication, groin and perianal dermatophytosis, has a very high model score but no trials or publications, so it stays at Evidence Level L5. Mechanistically it is plausible, since it is a dermatophyte infection closely related to the approved tinea pedis use. The related indication tinea corporis has several randomized comparative studies and could move forward as Proceed with Guardrails. Those studies are mostly small, open-label comparisons, and no Phase 3 evidence was confirmed.
To proceed, the following is needed:
- Targeted literature search or trials for tinea cruris. The combined tinea corporis/cruris studies (PMID 24249898, 28066103) should be reviewed in full.
- Package insert warnings and contraindications from the HSA, so safety screening can be completed
- Mechanism of action data for sertaconazole
- Confirmation of the approved indication text for the two Singapore registrations
- Review of whether the existing topical cream registration covers tinea cruris
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.