Hydrocortisone butyrate 0.1% lipocream in pediatric patients with atopic dermatitis

Area of Science:

• Dermatology
• Pediatric Medicine
• Pharmacology

Background:

• Topical corticosteroids are essential for managing atopic dermatitis.
• Limited safe and effective options exist for pediatric populations, especially infants.
• Hydrocortisone butyrate (HCB) is a topical corticosteroid with potential for pediatric use.

Purpose of the Study:

• To evaluate the efficacy and safety of hydrocortisone butyrate (HCB) 0.1% in a lipocream (LCr) vehicle.
• To assess HCB 0.1% LCr in infants and children aged 3 months to 18 years with atopic dermatitis.
• To compare HCB 0.1% LCr against its vehicle for treating pediatric atopic dermatitis.

Main Methods:

• A randomized, vehicle-controlled study involving 264 pediatric patients (3 months to <18 years).
• Participants had mild to moderate atopic dermatitis affecting at least 10% body surface area.
• HCB 0.1% LCr or LCr vehicle was applied twice daily for up to 1 month, without occlusion.

Main Results:

• HCB 0.1% LCr demonstrated statistically significant treatment success compared to the vehicle (P < 0.001).
• Significant improvements were observed in pruritus and Eczema Area and Severity Index (EASI) scores at day 29.
• No serious or significant adverse events were reported during the study.

Conclusions:

• HCB 0.1% in LCr is a safe and effective treatment for mild to moderate atopic dermatitis in pediatric patients.
• The study supports the use of HCB 0.1% LCr in infants and children as young as 3 months.
• HCB 0.1% LCr offers a valuable therapeutic option for managing pediatric atopic dermatitis effectively.