Fluconazole cream

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Efficacy and Safety of Fluconazole Cream for Superficial Mycosis

Introduction to Fluconazole Cream

Fluconazole, a member of the azole family, is widely recognized for its systemic antifungal properties. However, its application as a topical treatment has been limited due to its large molecular weight and hydrophilic nature . Recent studies have explored the potential of fluconazole cream formulations to treat various superficial mycoses effectively.

Comparative Efficacy of Fluconazole Cream

Fluconazole vs. Flutrimazole

A multicenter, double-blind, randomized study compared the antifungal efficacy and safety of fluconazole cream (0.5% and 1%) with flutrimazole cream (1%) in treating superficial mycosis. The study involved 162 subjects and found that both concentrations of fluconazole cream were equally effective and non-inferior to flutrimazole cream in achieving complete mycological cure after four weeks of application .

Fluconazole vs. Ketoconazole

Another study compared the efficacy of flutrimazole 1% cream with ketoconazole 2% cream in treating dermatophytosis and cutaneous candidosis. The results indicated that flutrimazole was as effective and safe as ketoconazole, with a higher proportion of patients achieving negative microscopy and culture results after four weeks of treatment . This suggests that fluconazole, being similar to flutrimazole in efficacy, could also be a viable alternative to ketoconazole for topical antifungal therapy.

Formulation Enhancements for Fluconazole Cream

Solid Lipid Nanoparticles (SLNs)

Research has shown that incorporating fluconazole into solid lipid nanoparticles (SLNs) can enhance its topical delivery and efficacy. A study formulated fluconazole-loaded SLNs and incorporated them into a gel, which demonstrated significant improvement in therapeutic response for treating Pityriasis Versicolor compared to a commercially available cream . The SLN formulation provided prolonged drug release and better stability, leading to superior clinical and mycological cure rates.

Microsponge-Based Delivery

Another innovative approach involved developing a microsponge-based topical delivery system for fluconazole. This formulation aimed to control drug release and enhance skin deposition. The microsponge gel demonstrated controlled release, higher retention in the stratum corneum, and prolonged antifungal efficacy in a mouse model, indicating its potential for treating primary and secondary skin infections .

Safety and Side Effects

Studies have consistently shown that fluconazole cream formulations are well-tolerated with minimal side effects. For instance, a study on the development of a fluconazole cream for Candida albicans confirmed that the formulation was non-irritant and had enhanced antifungal activity, reducing the side effects typically associated with fluconazole . Additionally, a combination therapy study involving oral fluconazole and topical ketoconazole reported no adverse effects, further supporting the safety of fluconazole in topical applications .

Conclusion

Fluconazole cream, particularly when enhanced with advanced delivery systems like SLNs and microsponge technology, shows promising efficacy and safety for treating superficial mycoses. These formulations offer improved drug release, stability, and skin retention, making fluconazole a viable option for topical antifungal therapy. Further research and clinical trials could solidify its place in dermatological treatments.

Sources and full results

Most relevant research papers on this topic

Study to compare the efficacy and safety of fluconazole cream with flutrimazole cream in the treatment of superficial mycosis: a multicentre, randomised, double‐blind, phase III trial

Fluconazole 0.5% and 1% creams are equally effective and non-inferior to flutrimazole 1% cream in treating superficial dermatomycosis.

RCT

2010·

10citations

·S. Yim et al.

Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1% cream: double‐blind, randomized comparative trial with ketoconazole 2% cream

Flutrimazole 1% cream is as effective and safe as ketoconazole 2% cream for treating Candida and dermatophyte skin infections.

RCT

1999·

16citations

·A. del Palacio et al.

An evaluation of butoconazole nitrate 2% site release vaginal cream (Gynazole-1) compared to fluconazole 150 mg tablets (Diflucan) in the time to relief of symptoms in patients with vulvovaginal candidiasis.

Butoconazole nitrate 2% Site Release vaginal cream (Gynazole-1) provides faster symptom relief for vulvovaginal candidiasis patients compared to oral fluconazole 150 mg tablets (Diflucan), with fewer reported adverse events.

RCT

2005·

26citations

·Larry S. Seidman et al.

Development of cream to enhance the antifungal activity and reduce the side effects of fluconazole for the treatment of Candida albicans

The optimized fluconazole cream formulation enhances antifungal activity and reduces side effects for the treatment of Candida albicans, making it a promising treatment option.

2022·

11citations

·N. Bhaskaran et al.

Fluconazole-loaded solid lipid nanoparticles topical gel for treatment of pityriasis versicolor: formulation and clinical study

Fluconazole-loaded solid lipid nanoparticles topical gels show a significantly faster therapeutic index in treating Pityriasis Versicolor compared to commercially available Candistan® cream.

Rigorous JournalHighly Cited

2017·

148citations

·Shaimaa El-Housiny et al.

Combination therapy of once-weekly fluconazole (100, 150, or 300 mg) with topical application of ketoconazole cream in the treatment of onychomycosis.

Once-weekly fluconazole with once-a-day topical ketoconazole cream is safe and effective for treating onychomycosis, with the recommended dosage being 150 mg once weekly for 6 months.

RCT

2004·

7citations

·Xuejun Chen et al.

Study of Fluconazole Release from O/W Cream and Water Soluble Ointment Bases

Changing the fatty alcohol type and liquid PEG type in O/W creams and PEG ointments can decrease fluconazole release and improve antifungal activity.

2013·

10citations

·Aml I. Mekkawy

Single‐dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double‐blind randomized controlled trial

Topical clotrimazole shows greater clinical response and less recurrence than oral fluconazole in treating pityriasis versicolor.

RCT

2010·

21citations

·M. Dehghan et al.

Once-weekly fluconazole (450 mg) for 4, 6, or 9 months of treatment for distal subungual onychomycosis of the toenail.

Fluconazole is an effective and safe treatment for distal subungual onychomycosis of the toenail, with the 9-month duration showing the most significant improvement.

RCTLarge Human Trial

1998·

57citations

·M. Ling et al.

Formulation and evaluation of microsponge gel for topical delivery of fluconazole for fungal therapy

Microsponge-based topical delivery systems for fluconazole show controlled release, enhanced drug deposition, and no skin irritation, making them a promising treatment for primary and secondary skin infections.

In Vitro Study

2016·

29citations

·Niravkumar R. Patel et al.

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