Related Experiment Videos
[Transcutaneous absorption of ketoconazole in infant after application of Ketoderm]
1Laboratoire de Pharmacocinétique, Laboratoires Janssen, Boulogne.
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.
Abstract:
The percutaneous absorption of ketoconazole was studied in 7 infants (1 to 5 month of age) with extensive seborrhoeic dermatitis (greater than 50% of the surface area), after application of a 2% ketoconazole cream (Ketoderm). The plasma concentrations of ketoconazole were measured by HPLC at the first, 5th and 10th day of the treatment. Despite the large surface involved, plasma levels ranging, from 0.018 to 0.133 micrograms/ml were measured. These values are low, as compared with the concentrations observed following oral administration (4 to 9 micrograms/ml), and suggest that the occurrence of systemic dose-dependent side effects is very unlikely. A careful monitoring of prescription remains however necessary.