Sertaconazole 2% Cream in Pediatric Patients
Sertaconazole 2% cream is safe and effective for children aged 2 years and older with superficial fungal infections including tinea corporis, tinea cruris, and seborrheic dermatitis, applied twice daily for 2–4 weeks depending on clinical response. 1
Evidence for Pediatric Use
Age and Safety Profile
An open-label multicenter study in 29 children (ages 2–16 years) demonstrated 100% clinical cure by 4 weeks with no local or systemic adverse effects, establishing sertaconazole's safety profile in the pediatric population. 1
The study included children as young as 2 years with culture-confirmed dermatophyte infections (predominantly Microsporum canis and Trichophyton rubrum), showing clinical cure rates of 31% at 1 week, 75% at 2 weeks, and 100% at 4 weeks. 1
No systemic absorption occurs with topical application, which is particularly important for pediatric safety considerations. 2
Dosing and Application
Apply sertaconazole 2% cream once or twice daily to affected areas for 2–4 weeks. The twice-daily regimen showed superior efficacy in comparative trials. 2, 3
For tinea corporis and tinea cruris specifically, twice-daily application for 28 days achieved 90.6% efficacy (defined as pathogen eradication plus clinical score reduction). 3
Specific Pediatric Indications
Diaper Dermatitis Candidiasis:
Sertaconazole 2% cream applied twice daily for 14 days achieved 88.8% total clinical and mycological cure in 27 infants with diaper dermatitis candidiasis, with only one case (3.7%) of mild skin irritation that did not require discontinuation. 4
The study isolated Candida albicans in 88.8% of cases, with symptom scores dropping from 7.1 to 0.4 units by follow-up. 4
Seborrheic Dermatitis:
- Sertaconazole 2% cream demonstrated excellent efficacy for seborrheic dermatitis, with 83.3% of patients achieving slight or no symptoms after treatment, comparable or superior to ketoconazole 2% cream. 5
Spectrum of Activity
Sertaconazole maintains antifungal activity against clinical isolates of dermatophytes with reduced susceptibility to other azoles (including fluconazole-resistant strains with MICs ≥16 μg/mL), making it valuable when other topical azoles fail. 2
The drug exhibits both fungistatic and fungicidal activity depending on concentration, with broad-spectrum coverage against Trichophyton, Epidermophyton, Microsporum, Candida, and Cryptococcus species. 2
Comparative Efficacy
In a randomized trial of 631 patients with cutaneous mycoses, sertaconazole 2% cream twice daily achieved significantly higher clinical and mycological cure rates than miconazole 2% cream, with faster time to cure. 2
Both cream and solution formulations (2%) showed comparable efficacy (90.6% vs 88.9%) in a noninferiority trial of 313 patients. 3
Important Clinical Considerations
Treatment Duration Algorithm
- Tinea corporis/cruris: 2–4 weeks twice daily; assess at 2 weeks and continue if partial response 1
- Diaper dermatitis candidiasis: 14 days twice daily with 2-week follow-up 4
- Seborrheic dermatitis: 2–4 weeks; reassess at 2 weeks 5
Common Pitfalls to Avoid
Do not confuse topical sertaconazole with systemic azoles: The evidence provided discusses systemic ketoconazole contraindications in children due to hepatotoxicity 6, 7, but this does not apply to topical sertaconazole, which has no systemic absorption. 2
Ensure mycological confirmation when possible, particularly for treatment failures, as the drug's efficacy was established in culture-confirmed cases. 1
Monitor for the rare occurrence of contact dermatitis (reported in <4% of adult studies), though the pediatric study showed no adverse effects. 2, 1
When Sertaconazole May Be Preferred
Infections resistant to other topical azoles (fluconazole, miconazole, clotrimazole), given sertaconazole's maintained activity against azole-resistant dermatophytes 2
Diaper area candidiasis where the combination of antifungal and anti-inflammatory properties may be beneficial 4
Patients requiring once-daily dosing for compliance, as once-daily application showed efficacy in the pediatric dermatophytosis study 1