Is Sertaconazole 2% cream safe and effective for children older than two years with superficial fungal infections (e.g., tinea corporis, tinea cruris, seborrheic dermatitis), and what is the recommended dosing and treatment duration?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 23, 2026View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

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

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.