Onset of pruritus relief with pimecrolimus cream 1% in adult patients with atopic dermatitis: a randomized trial.
BACKGROUND
Pimecrolimus cream 1% (Elidel, Novartis Pharmaceuticals AG) effectively improves/relieves pruritus associated with atopic dermatitis (AD), but few data are available regarding the timing of relief. The purpose of this study was to investigate the timing of pruritus relief produced with pimecrolimus in adults with mild/moderate AD and moderate/severe pruritus.


METHODS
Patients were randomized to 7 days of treatment with pimecrolimus (n = 100) or vehicle (n = 98). Pruritus severity was assessed daily on a 4-point scale (0 = absent, 3 = severe), reflecting the previous 24 h experience. Patients who completed this core study were eligible to enter a voluntary 5-week, open-label extension study.


RESULTS
A significant effect was noted within 48 h of treatment, with pruritus improving in 56% of pimecrolimus-treated patients and 34% of vehicle-treated patients (P = 0.003). Pruritus relief was maintained during the remainder of the core and extension phases, and was accompanied by an improvement in the Investigator's Global Assessment score.


CONCLUSIONS
Pimecrolimus cream 1% significantly reduced pruritus within 48 h.
Kaufmann
R
R
J W Goethe University Hospital, Frankfurt, Germany.
Bieber
T
T
Helgesen
A L
AL
Andersen
B Lasthein
BL
Luger
T
T
Poulin
Y
Y
Al-Hafidh
J
J
Paul
C
C
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011336:Probability; D011537:Pruritus / Q000175:diagnosis / Q000188:drug therapy*; D012016:Reference Values; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus