Hydrocortisone butyrate 0.1% lotion in the treatment of atopic dermatitis in pediatric subjects.
BACKGROUND
Hydrocortisone butyrate (HCB) is currently marketed as a cream, ointment, and solution. A new lotion formulation of hydrocortisone butyrate 0.1% (Locoid lotion) has been developed and evaluated.


OBJECTIVE
The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD).


METHODS
In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. "Treatment success" was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events.


RESULTS
Analyses of the final PGA score showed a significant treatment effect (P <.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable.


CONCLUSIONS
The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD.


CONCLUSIONS
Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.
Matheson
Robert
R
Oregon Medical Research Center PC, Portland, OR, USA.
Kempers
Steven
S
Breneman
Debra
D
Draelos
Zoe
Z
Johnson
Candice E
CE
Loss
Robert
R
Hogan
Daniel J
DJ
Schoenfeld
Robert
R
Checketts
Scott
S
Kircik
Leon
L
Fivenson
David
D
Hebert
Adelaide A
AA
Williams
Judith
J
Hamlin
Regina
R
Groisser
Daniel
D
Piacquadio
Dan
D
D000279:Administration, Cutaneous; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D012720:Severity of Illness Index; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C007975:hydrocortisone-17-butyrate; D006854:Hydrocortisone