Original ArticlesSafety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants☆,☆☆
Section snippets
Study design and patients
Enrolled subjects met the following inclusion criteria: age, 3 to 23 months; written consent of legal guardian; clear diagnosis of AD,22 affecting ≥5% of total body surface area and with a baseline Investigator's Global Assessment (IGA) of 2 (mild) or 3 (moderate), based on the degree of erythema and infiltration/papulation. The following were reasons for exclusion: immunocompromised subject, other concurrent or active skin disease or viral skin infections, or a known hypersensitivity to study
Patients
A total of 186 patients were randomly assigned to receive either pimecrolimus cream 1% bid (n = 123) or corresponding vehicle (n = 63). There were no clinically or statistically significant demographic differences between the two groups (Table I).Baseline disease severity was similar for the two groups (Table I). In total, 109 (88.6%) patients in the pimecrolimus group completed the 6-week, double-blind phase, compared with 33 (52.4%) in the vehicle group. Eight (6.5%) patients in the
Discussion
This study demonstrates that pimecrolimus cream 1% is highly effective and safe for the treatment of mild to moderate AD in infants. In the 6-week double-blind phase, 70% of patients with moderate AD showed improvement, and >65% of patients with mild AD improved. The majority of patients receiving pimecrolimus quickly achieved clear or almost clear status. Clinically relevant improvements in AD were demonstrated at the first return visit on day 8, with statistically significant differences
Acknowledgements
We thank all participating investigators, including A. Halbert (Australia); F. F. Alonso, S. Pereira, M. C. Pires (Brazil); C. Lynde, K. Papp (Canada); K. Deichmann, H. Hamm, P. Höger (Germany); M. Groenewald, P. Jeena, D. Patel, N. L. Raboobee, S. Reyneke (South Africa); M. Casado, J. Escudero, and J.-M. Hernanz-Hermosa (Spain). In addition, we also thank Simon Hedgecock, Francois Langlo, and Michael Graeber of Novartis Pharma AG, Basel, Switzerland.
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2017, Obstetrics and Gynecology Clinics of North AmericaCitation Excerpt :Once the pruritus and physical examination findings are improved, the frequency of use can be tapered or the medicine can be substituted for a lower potency topical corticosteroids. Topical calcineurin inhibitors such as tacrolimus (Protopic) ointment or pimecrolimus (Elidel) cream can be helpful as adjunctive or even primary treatment, especially when steroid atrophy is present on examination.5 If a patient does not improve after this management plan is implemented, a biopsy should be seriously considered, especially to rule out an alternative diagnosis such as malignancy.
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Supported by a research grant from Novartis Pharmaceuticals Corp.
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Reprint requests: Vincent C. Ho, MD, Department of Medicine, Division of Dermatology, University of British Columbia, 835 West 10th Avenue, Vancouver, BC V5Z 4E8, Canada.