Clotrimazole
| Evidence Level: L4 | Predicted Indications: 3 |
Table of Contents
Clotrimazole: From Antifungal Therapy to Acne
One-Sentence Summary
Clotrimazole is an azole antifungal, widely marketed in the US as a topical product for fungal skin and mucosal infections. The TxGNN model predicts it may be effective for acne, but the only supporting evidence is 1 suspended clinical trial of a three-drug combination and no publications.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Acne (disease) |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the input. Clotrimazole is known to be an azole antifungal that blocks ergosterol synthesis in fungi. Its efficacy in fungal infections is well established.
The link to acne is indirect. Clotrimazole may have a minor anti-inflammatory or anti-Malassezia effect, but this is unproven for acne. Acne is mainly a disorder of sebaceous glands, follicular keratinization and bacterial colonization, none of which the antifungal mechanism directly targets.
The very high TxGNN score (99.86%) is a model prediction only. The single related trial tests a fixed combination, so any effect cannot be attributed to clotrimazole.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01244256 | Phase 2/3 | Suspended | 80 | Beclomethasone + gentamicin + clotrimazole cream, tested in contaminated dermatosis with bilateral symmetrical lesions. No results reported. |
The trial is titled for acne, but its summary describes contaminated dermatosis. It is a fixed combination, so it cannot show a clotrimazole-specific effect.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA072641 | Clotrimazole | Cream | Sun Pharmaceutical Industries, Inc. |
| M005 | Clotrimazole | Cream | Proficient Rx LP |
| M005 | Clotrimazole | Cream | Preferred Pharmaceuticals Inc. |
| M005 | Terrasil Tinea Treatment | Ointment | Aidance Scientific, Inc. |
| ANDA072640 | Clotrimazole | Cream | Sun Pharmaceutical Industries, Inc. |
Available dosage forms include cream, ointment, soap and solution.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The acne prediction rests on a model score alone. The only trial is suspended, has no results, and tests a combination product, so the clotrimazole contribution cannot be isolated. No literature supports this indication.
To proceed, the following is needed:
- Package insert warnings and contraindications, which are required before safety screening
- Detailed mechanism of action data
- Clotrimazole monotherapy evidence in acne, such as a randomized trial or mechanistic study
- Clarification of the original labeled indications, which are empty in the source data
Note on other predictions: The rank 2 prediction, vulvovaginitis, has much stronger evidence: several completed Phase 3/4 trials and multiple RCTs. However, it appears to be an established candidal use rather than true repurposing, so confirm the labeled indication before presenting it as novel. The rank 3 prediction, postmenopausal atrophic vaginitis, is not supported by clinical evidence.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.