Miconazole
| Evidence Level: L4 | Predicted Indications: 1 |
Table of Contents
Miconazole: Acne (disease)
One-Sentence Summary
Miconazole is an imidazole antifungal used on the skin and vaginally. The TxGNN model predicts it may be useful for acne. Evidence is limited: no clinical trials are registered, and 4 publications touch on the topic (one review, one small split-face study, one study of a look-alike condition, and one laboratory study). 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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| 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 general azole pharmacology, miconazole blocks fungal CYP51 (lanosterol 14-alpha-demethylase), which stops ergosterol synthesis and damages the fungal cell membrane.
Three lines of reasoning link this to acne. First, a laboratory study (PMID 20045949) tested azole antifungals against Propionibacterium acnes, the bacterium involved in acne vulgaris. Second, miconazole acts against Malassezia (Pityrosporum), which causes a folliculitis that looks like acne and is often misdiagnosed as it (PMID 8593718). Third, a review describes anti-inflammatory and antibacterial effects of miconazole on skin disorders (PMID 18627330).
The TxGNN score is a computational ranking, not clinical evidence. The only human data on acne itself is one small split-face assessment in mild catamenial acne (PMID 15536660), and its abstract gives no result for miconazole.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 18627330 | 2008 | Review | Expert Opin Pharmacother | Reviews the effects of miconazole on skin disorders, including antibacterial and anti-inflammatory actions |
| 15536660 | 2004 | Clinical study (split-face, small) | Skin Res Technol | Split-face assessment in mild inflammatory catamenial acne; limited, small-scale human data |
| 8593718 | 1995 | Clinical study | Clin Exp Dermatol | Therapeutic trials in 62 patients with Malassezia folliculitis, a condition often mistaken for acne vulgaris; not true acne |
| 20045949 | 2010 | In vitro study | Biol Pharm Bull | Azole antifungals tested for activity against P. acnes isolated from acne patients |
India Market Information
At least 20 single-ingredient miconazole licences are recorded, all valid, and the list may be partial. The main ones are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 150934 | Nadibact Plus Cream (Cipla Ltd) | Cream, 10 gm tube | Not available |
| 147881 | Mesotar NM Cream (Terma Medicare India Pvt Ltd) | Cream, 10 gm tube | Not available |
| 139460 | Micon Ointment (Mepro Pharmaceuticals) | Ointment, 15 gm tube | Not available |
| 35001 | Candifem Vaginal Tablet (Meyer Organics Pvt Ltd) | Vaginal tablet, strip of 6 | Not available |
| 36823 | Candistat Cream (Merck Ltd) | Cream, 15 gm tube | Not available |
Safety Considerations
- Drug Interactions: 376 interactions are recorded. Examples rated Moderate include paclitaxel, fentanyl, acalabrutinib, nifedipine, ethinylestradiol, alprazolam, amiodarone, amitriptyline, amlodipine and hydrocodone. Examples rated Minor include dolutegravir, loratadine and amphotericin B.
Please also refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence level is L4. The support is one review of miconazole’s antibacterial and anti-inflammatory effects on skin disorders, with no clinical study in acne. The very high TxGNN score is a computational prediction only.
To proceed, the following is needed:
- Controlled clinical studies of topical miconazole in acne vulgaris
- Detailed mechanism of action data
- Package insert warnings and contraindications from India Pharma
- Confirmation of the approved indication text in the local licence records
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.