Sertaconazole
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Sertaconazole
- Sertaconazole: From Superficial Fungal Infections to Dermatophytosis of Groin and Perianal Area
Sertaconazole: From Superficial Fungal Infections to Dermatophytosis of Groin and Perianal Area
One-Sentence Summary
Sertaconazole is a topical imidazole antifungal already established internationally for superficial fungal skin infections (dermatophytosis, cutaneous candidiasis, pityriasis versicolor), though it is not currently marketed in India and no formal original-indication record exists in this evidence pack. The TxGNN model’s top-ranked prediction is Dermatophytosis of Groin and Perianal Area (tinea cruris), but no clinical trials or literature were retrieved under this specific disease term — evidence for closely related indications (tinea corporis, cutaneous candidiasis, superficial mycosis) is substantial and should be considered alongside this top prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in this evidence pack (India: not marketed; no formal dossier indication text on file). Independent literature in this pack identifies sertaconazole as an established topical antifungal for dermatophytosis, cutaneous candidiasis, and pityriasis versicolor. |
| Predicted New Indication | Dermatophytosis of Groin and Perianal Area (tinea cruris) |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L5 (model prediction only — no clinical trials or literature retrieved for this specific term) |
| India Market Status | ✗ Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data was not available in the structured drug record for this evidence pack (flagged as a High-severity data gap requiring DrugBank API lookup). However, the literature collected under related predicted indications in this same pack (e.g., PMID 19275277, PMID 23566144, PMID 21746955) consistently describes sertaconazole as a third-generation imidazole antifungal with a dual mechanism: at standard concentrations it inhibits 14-α-lanosterol demethylase, blocking ergosterol synthesis (fungistatic effect); at higher concentrations, its distinctive benzothiophene ring allows direct binding to non-sterol lipids in the fungal cell membrane, increasing permeability and producing a fungicidal effect. This dual action, plus reported anti-inflammatory and antipruritic properties, distinguishes it from older azoles.
Dermatophytosis of the groin and perianal area (tinea cruris) is caused by the same dermatophyte genera (Trichophyton, Epidermophyton) responsible for tinea corporis and tinea pedis — indications for which this evidence pack already contains strong RCT-level support (see Rank 2 below). Notably, the review by Croxtall & Plosker (PMID 19275277, included under the Rank 2/Rank 7/Rank 9 evidence pools of this same pack) explicitly lists tinea cruris among sertaconazole’s EU-approved indications for dermatophytosis. This suggests the top-ranked prediction may reflect an indication that is already clinically supported for this drug class, rather than a genuinely novel repurposing signal — the absence of literature under this exact disease term likely reflects a search-term/taxonomy gap rather than a true absence of supporting evidence.
Given the shared pathogen spectrum, shared topical route, and shared drug class rationale, the mechanistic plausibility for this prediction is high — but this report can only formally credit evidence that was actually retrieved and linked to this specific disease term.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available under this specific disease term.
Note: Substantial literature exists for the closely related indication “tinea corporis” (Rank 2) and “superficial mycosis” (Rank 7) elsewhere in this evidence pack — see below for reference, as these may inform the clinical plausibility of this prediction.
Closely Related Indication: Tinea Corporis (Rank 2, Score 99.94%, Evidence Level L2)
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24249898 | 2013 | RCT | Indian J Dermatol | Comparative trial: terbinafine 1% cream vs sertaconazole 2% cream in tinea corporis/cruris |
| 34760651 | 2021 | RCT | Perspect Clin Res | Sertaconazole 2% vs luliconazole 1% cream in dermatophytoses — efficacy, safety, cost-effectiveness |
| 24249897 | 2013 | RCT | Indian J Dermatol | Sertaconazole 2% vs butenafine 1% in tinea infections |
| 25386455 | 2014 | Observational | J Clin Diagn Res | Sertaconazole vs clotrimazole in tinea corporis |
| 28066103 | 2016 | RCT | Indian J Pharmacol | Once-daily sertaconazole vs terbinafine in localized dermatophytosis |
| 30409926 | 2019 | RCT | Indian J Dermatol Venereol Leprol | Amorolfine 0.25% vs sertaconazole 2% cream in limited dermatophytosis |
| 19275277 | 2009 | Review | Drugs | Confirms EU approval for dermatophytosis including tinea cruris |
India Market Information
Sertaconazole is not currently marketed in India (market_status: Not marketed, total_licenses: 0). No product registrations, brand names, or approved indication texts are on file in this evidence pack.
Safety Considerations
Please refer to the package insert for safety information. Key warnings, contraindications, and drug-drug interaction data were not available in this evidence pack — TFDA-equivalent label data (warnings/contraindications) is flagged as a Blocking data gap that must be resolved before any S1 safety pre-assessment can proceed.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction (dermatophytosis of groin and perianal area) has no directly linked clinical trial or literature evidence in this pack, meeting only the L5 (model-prediction-only) threshold. While mechanistic plausibility is high — and closely related indications (tinea corporis, cutaneous candidiasis, superficial mycosis, pityriasis versicolor) carry L2-level RCT support — a Hold is warranted for this specific term pending confirmation that the search-term gap, not a true absence of evidence, explains the empty evidence set.
To proceed, the following is needed:
- Resolve DG001 (Blocking): obtain TFDA/regulatory label warnings and contraindications before any safety pre-assessment (S1) can begin.
- Resolve DG002 (High): obtain formal MOA data via DrugBank API to support mechanistic-relevance scoring.
- Re-run literature/trial search using synonym terms (“tinea cruris”, “jock itch”, “groin dermatophytosis”) to confirm whether the apparent evidence gap for the top prediction is a taxonomy artifact.
- If confirmed as equivalent to tinea cruris, re-evaluate this indication using the L2-level evidence already available for tinea corporis and superficial mycosis in this same pack.
- Confirm India market-entry regulatory pathway, since the drug currently holds zero registrations.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.