Twice-daily versus once-daily applications of pimecrolimus cream 1% for the prevention of disease relapse in pediatric patients with atopic dermatitis.
Ruer-Mulard M, Aberer W et al.
Pediatr Dermatol. 2009 Sep-Oct;26(5):551-8.
This article demonstrates that a once daily application of a calcineurin inhibitor (pimecrolimus in this stidy) is enough to prevent the flares of atopic dermatitis (AD). At the same time it reduces the side effects risk, thus enhancing the compliance in the treatment of this chronic condition. In this study, comparison of twice-daily and once-daily applications of pimecrolimus cream 1% is done for prevention of atopic dermatitis relapses in pediatric patients. The abstract is shown below.
METHODS: This multicenter trial recruited 300 outpatients aged from 2 to 17 years of age, with mild-to-severe AD. The patients were initially treated with twice-daily topical pimecrolimus until complete clearance or for up to 6 weeks (open-label period). Those who achieved a decrease of at least 1 point in the Investigator’s Global Assessment (IGA) score were then randomized to double-blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of remission (IGA = 0). The primary efficacy end point of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by IGA score > or = 3 and pruritus score > or = 2).
RESULTS: Out of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily (n = 134 in each group). The relapse rate was lower in the twice-daily dose group (9.9%) than that in the once-daily dose group (14.7%), but analysis of the time to disease relapse did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31-1.30).
CONCLUSION: Treatment of active AD lesions with pimecrolimus cream 1% twice daily, followed by the once-daily dosing regimen, was adequate to prevent subsequent AD relapses over 16 weeks in pediatric patients.
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