Clotrimazole
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Clotrimazole: Acne (disease)
One-Sentence Summary
Clotrimazole is an azole antifungal that has been marketed in Canada for many years. The TxGNN model predicts it may be useful for acne, but the supporting evidence is thin: 1 clinical trial (a suspended combination-product study) and no publications.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Acne (disease) |
| TxGNN Prediction Score | 0.9986 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 20) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for clotrimazole is not available in the data compiled for this report. In general, clotrimazole inhibits fungal CYP51 (lanosterol 14-alpha-demethylase) and has reported antimicrobial and anti-inflammatory activity on the skin.
A plausible link to acne is through reduced colonisation by yeasts such as Malassezia or Candida and lower follicular inflammation. This link is indirect. Acne is mainly a disorder of sebum production, follicular blockage, Cutibacterium acnes and inflammation, and an antifungal does not directly target these. The high score (0.9986) is a computational prediction only and is not evidence of clinical benefit.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01244256 | Phase 2/3 | Suspended | 80 | Fixed-dose combination of beclomethasone 0.025% + gentamicin 0.1% + clotrimazole 1% cream in subjects with contaminated dermatosis showing bilateral symmetrical lesions. No results reported. |
This trial tested a combination product, so any effect cannot be attributed to clotrimazole alone. The corticosteroid and antibiotic components confound the result. The trial is suspended, and the registry text does not clearly confirm that acne was the studied condition. For these reasons it is not counted as direct evidence for clotrimazole in acne.
Literature Evidence
Currently no related literature available.
Canada Market Information
Clotrimazole is marketed in Canada, and all 20 single-ingredient licences in the local data are valid. The records are partial, and the table below lists five of them. Dosage form and approved-indication text are not recorded in the local data.
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02229378 | Clotrimazole Vaginal 6 | — | — |
| 02150859 | Canesten Comfortab 1 | — | — |
| 02229380 | Clotrimazole Topical | — | — |
| 02462397 | Clotrimazole External Antifungal Cream | — | — |
| 02264102 | Canesten Combi 1 Day | — | — |
Safety Considerations
- Drug Interactions: 100 interactions are recorded. Major-level interactions include fentanyl, alfentanil, hydrocodone and amiodarone. Moderate-level examples include paclitaxel, abemaciclib, acalabrutinib, nifedipine, amlodipine, apixaban, alprazolam, estradiol, levonorgestrel and norethisterone.
For warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The only related trial is a suspended study of a three-drug combination with no results, and no publications address clotrimazole in acne. The mechanistic link is indirect, so the prediction rests on the model score alone.
To proceed, the following is needed:
- Mechanism-of-action data for clotrimazole
- Package insert warnings and contraindications from Health Canada
- Preclinical or clinical studies of clotrimazole as a single agent in acne
- Clarification of the condition studied in NCT01244256 and whether the trial will resume
- Assessment of whether a topical formulation suits acne-prone skin
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.