Miconazole

Evidence Level: L4 Predicted Indications: 1

Table of Contents

  1. Miconazole
    1. Pharmacist Assessment Report
    2. Miconazole: Acne (disease)
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. Australia Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Miconazole: Acne (disease)

One-Sentence Summary

Miconazole is a topical imidazole antifungal marketed in Australia as a cream. The TxGNN model predicts it may be relevant to acne (disease), but the supporting evidence is limited: no registered clinical trials and 4 publications, none of which is a controlled clinical study of miconazole in acne. The evidence level is L4.

Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Acne (disease)
TxGNN Prediction Score 0.9954
Evidence Level L4
Australia Market Status Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items 1 (valid: 1)
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, miconazole is an imidazole antifungal, a class that inhibits fungal ergosterol synthesis and is used on the skin.

Several lines of indirect evidence link it to acne:

  • Antibacterial activity: an in vitro study found that azole antifungals, including imidazoles, are active against Propionibacterium acnes, the bacterium implicated in acne vulgaris (PMID 20045949).
  • Malassezia overlap: Malassezia (Pityrosporum) folliculitis is often misdiagnosed as acne vulgaris. An antifungal such as miconazole may therefore help in acne-like lesions that are in fact fungal (PMID 8593718).
  • Anti-inflammatory effects: a review describes antibacterial and anti-inflammatory effects of miconazole on skin disorders (PMID 18627330).

These observations support a plausible hypothesis, but they do not show that miconazole treats acne itself.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID Year Type Journal Key Findings
18627330 2008 Review Expert Opin Pharmacother Review of miconazole’s multifaceted effects on skin disorders, including antibacterial and anti-inflammatory actions
15536660 2004 Cohort Skin Res Technol Split-face clinical and bioinstrumental assessment in mild inflammatory catamenial acne; limited human data
8593718 1995 Cohort Clin Exp Dermatol 62 patients with Pityrosporum folliculitis, a condition frequently misdiagnosed as acne vulgaris; diagnosis and therapeutic trials
20045949 2010 In vitro Biol Pharm Bull Azole antifungals tested in vitro against P. acnes isolated from patients with acne vulgaris

Australia Market Information

ARTG Number Product Name Dosage Form Approved Indication
ARTG 9027D Daktarin Cream containing miconazole nitrate 20 mg per g, 30 g Not stated in the data compiled for this report

Safety Considerations

  • Drug Interactions: 100 potential interactions were identified in the interaction data compiled for this report. Examples rated Moderate include paclitaxel, fentanyl, alfentanil, acalabrutinib, nifedipine, amlodipine, amiodarone, amitriptyline, alprazolam, ethinylestradiol, estradiol and hydrocodone. Examples rated Minor include dolutegravir, loratadine and amphotericin B. Only the first 20 entries were reviewed, so this list is partial.

Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The evidence level is L4. The only literature directly on miconazole’s skin effects is a review (PMID 18627330), and no clinical study has tested miconazole in acne. The other supporting papers are a small split-face study, a study of a different condition (Pityrosporum folliculitis) and an in vitro study. The prediction score is high (0.9954), but the clinical evidence is not yet enough to support progression.

To proceed, the following is needed:

  • Controlled clinical studies of topical miconazole in acne vulgaris, ideally randomised and against standard therapy
  • Mechanism of action data to support the anti-inflammatory and antibacterial hypothesis
  • Review of the TGA-approved Product Information for warnings, contraindications and interactions relevant to the topical route

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.

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