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[Transcutaneous absorption of ketoconazole in infant after application of Ketoderm]

J C Levron1, A Taieb

  • 1Laboratoire de Pharmacocinétique, Laboratoires Janssen, Boulogne.

Therapie
|January 1, 1991
PubMed

Insights

Percutaneous absorption of ketoconazole cream in infants with severe seborrheic dermatitis showed low plasma concentrations. This suggests a minimal risk of systemic side effects, though monitoring is advised.

Area of Science:

  • Dermatology
  • Pharmacokinetics
  • Pediatrics

Context:

  • Infants with extensive seborrheic dermatitis (affecting >50% body surface area) were treated with 2% ketoconazole cream.
  • Seborrheic dermatitis is a common inflammatory skin condition affecting infants.

Purpose:

  • To evaluate the percutaneous absorption and systemic exposure of ketoconazole in infants with extensive seborrheic dermatitis.
  • To assess the safety profile regarding systemic side effects after topical ketoconazole application.

Summary:

  • Ketoconazole cream (2%) was applied to 7 infants (1-5 months old) with extensive seborrheic dermatitis.
  • Plasma ketoconazole concentrations were measured using High-Performance Liquid Chromatography (HPLC) on days 1, 5, and 10.
  • Measured plasma levels (0.018-0.133 µg/ml) were significantly lower than those from oral administration (4-9 µg/ml).

Impact:

  • Topical ketoconazole in infants with extensive seborrheic dermatitis results in low systemic absorption.
  • The risk of systemic dose-dependent side effects is considered very unlikely.
  • Continued careful monitoring of ketoconazole prescriptions in this population is recommended.

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