Clotrimazole

Evidence Level: L5

Predicted Indications: 2

Clotrimazole

Pharmacist Assessment Report

Clotrimazole: Acne (disease)

One-Sentence Summary

Clotrimazole is a topical and mucosal azole antifungal that is widely marketed in India. The TxGNN model predicts it may be effective for acne (disease), but only 1 clinical trial (a suspended study of a three-drug combination) and no publications relate to this prediction, so the prediction is not yet supported by direct clinical evidence.

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
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?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Clotrimazole is generally known as an azole antifungal that inhibits fungal CYP51 (lanosterol 14-alpha-demethylase), and it has reported antimicrobial and anti-inflammatory activity on skin.

A possible link to acne is through reducing Malassezia or other microbial burden on the skin and through anti-inflammatory effects. However, acne is driven mainly by sebum production, follicular hyperkeratinization, and Cutibacterium acnes. The mechanistic fit is therefore indirect.

The very high TxGNN score (0.9986) is a computational prediction. It does not replace clinical evidence, and no cited study directly shows that clotrimazole alone benefits acne.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01244256	Phase 2/3	Suspended	80	Compared a fixed combination of beclomethasone, gentamicin and clotrimazole cream in contaminated dermatosis with bilateral symmetrical lesions. No results available. Because of the combination design, any effect cannot be attributed to clotrimazole alone.

This trial is registered under an acne-related title, but the study text describes contaminated dermatosis, so it does not directly establish clotrimazole’s efficacy in acne.

Literature Evidence

Currently no related literature available.

India Market Information

Authorization Number	Product Name	Dosage Form
Registration No. 47293	Curitop Dusting Powder	Dusting powder (100 g bottle)
Registration No. 109411	Itchnil Cream	Cream (20 g tube)
Registration No. 110404	Itchgo Cream	Cream (15 g tube)
Registration No. 41401	Canazole Mouth Wash	Mouth wash (15 ml)
Registration No. 50197	Canfem 100mg Tablet VT	Vaginal tablet (strip of 6)

All 20 licences listed in the local data are valid single-ingredient products. The list may be partial, so only the main authorizations are shown here.

Safety Considerations

Drug Interactions: 481 interactions were recorded. Major-level interactions in the sample reviewed include fentanyl, alfentanil, amiodarone and hydrocodone. Moderate-level examples include paclitaxel, abemaciclib, acalabrutinib, nifedipine, amlodipine, apixaban, alprazolam, estradiol and levonorgestrel.

Please refer to the package insert for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The only related trial tested a three-drug combination, is suspended and has no results. No publication directly studies clotrimazole in acne, and the mechanistic link is indirect. The evidence level is therefore L5 despite the high model score.

To proceed, the following is needed:

Controlled clinical studies of single-agent clotrimazole in acne
Detailed mechanism of action data
Package insert warnings and contraindications for the relevant formulations
Confirmation that a suitable topical formulation and route fit acne treatment

Disclaimer

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