Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants.
OBJECTIVE
The safety and efficacy of a 1% cream formulation of pimecrolimus, a selective, nonsteroid immunomodulator, was studied in infants with atopic dermatitis (AD).


METHODS
During a 6-week double-blind phase, 186 infants with mild/moderate AD were randomly assigned to twice-daily pimecrolimus cream 1% or vehicle. All patients were subsequently treated with open-label pimecrolimus for 20 weeks.


RESULTS
At the end of the double-blind phase, 54.5% and 23.8% of patients in the pimecrolimus and vehicle groups, respectively, were clear or almost clear of AD (P <.001). Similar improvements were observed in the Eczema Area and Severity Index, pruritus assessment, and the care giver's assessment. By the first return visit, 69.9% and 36.5% of pimecrolimus and vehicle-treated patients, respectively, achieved absent or mild pruritus. Efficacy during the double-blind phase was maintained throughout the open-label phase. Vehicle-treated patients transferring to open-label pimecrolimus rapidly achieved disease control comparable to those receiving continuous pimecrolimus. There were no significant differences between groups in application site reactions or skin infections. Most adverse events were mild or moderate and unrelated to treatment.


CONCLUSIONS
Pimecrolimus was safe in infants with AD, with rapid and sustained efficacy. Pimecrolimus holds promise as a valuable new treatment option for the youngest patients with AD.
Ho
Vincent C
VC
Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Gupta
Aditya
A
Kaufmann
Roland
R
Todd
Gail
G
Vanaclocha
Francisco
F
Takaoka
Roberto
R
Fölster-Holst
Regina
R
Potter
Paul
P
Marshall
Katherine
K
Thurston
Mark
M
Bush
Christopher
C
Cherill
Robert
R
D000279:Administration, Cutaneous; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000145:classification / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007223:Infant; D008297:Male; D009824:Ointments; D010612:Pharyngitis / Q000139:chemically induced; D012141:Respiratory Tract Infections / Q000139:chemically induced; D012449:Safety; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus