A Bilateral Comparison Study of Pimecrolimus Cream 1% and a Topical Medical Device Cream in the Treatment of Patients With Atopic Dermatitis

July 2011 | Volume 10 | Issue 7 | Original Article | 735 | Copyright © July 2011


Jason J. Emer MD, Amylynne Frankel MD, Andrew Sohn BS, Mark Lebwohl MD

Mount Sinai School of Medicine, Department of Dermatology, New York, NY

Abstract
Corticosteroids are the mainstay of therapy for atopic dermatitis, but long-term use is associated with adverse effects. We sought to evaluate the clinical efficacy of two steroid-sparing creams for atopic dermatitis. Twenty patients were enrolled in an investigatorblinded, bilateral comparison study. Patients applied pimecrolimus cream twice daily to a target lesion on one side of the body and also applied a topical medical device cream three times daily on a symmetrical target lesion on the opposite side of the body for four weeks. Clinical assessments including Physician Global Assessment (PGA), Target Lesion Symptom Score (TLSS), subject selfassessment and digital photography were performed at the baseline, 2 week, and 4 week visits. Seventy-five percent of patients (pimecrolimus, 15 of 20; topical medical device, 15 of 20) were rated "clear" (0) or "almost clear" (1) by PGA for both medications after four weeks. Percent improvement of the PGA from randomization for pimecrolimus cream and the topical medical device cream were 72.50 and 71.67 respectively (P=0.9283). PGA scores decreased significantly from baseline for both treatments (P=0.004). Overall, there was no statistically significant difference between treatment groups for PGA scores throughout the study (P=0.8236). No cutaneous side effects were noted. Our study was limited by a small sample size and lack of double-blinding; however, both treatments were found to be safe and effective in treating atopic dermatitis over four weeks. Significant improvements were noted for all efficacy variables. In conclusion, a lipid-rich, non-steroidal, topical medical device cream was as effective in improving atopic dermatitis as pimecrolimus cream.

J Drugs Dermatol. 2011;10(7):735-743.

INTRODUCTION

Atopic dermatitis (AD) is a chronically relapsing, inflammatory and pruritic skin disease. In industrialized countries, the prevalence of AD is 10−20 percent in children and 1−3 percent in adults.1 Acute exacerbations present clinically as pruritic, erythematous papules with excoriation and serous exudates.2,3 Chronic disease is characterized by dry, scaly skin (xerosis) and thickened, lichenified skin with fibrotic papules. Xerosis signifies a compromised epidermal barrier and can lead to disease exacerbation or skin infections.2,4 Patients with moderate-to-severe AD experience an average of seven to nine flares per year, with the average flare lasting 16 to 19 days.5 Flare reduction is essential in effective, long-term management of AD, although it is quite challenging due to the chronic and relapsing nature of the disease process.
Currently, the best clinical practice in the long-term management of AD requires a multi-therapeutic approach, which includes resolving short-term flares, controlling symptoms between major flares and prolonging the time until the subsequent flare.6 The most commonly used treatment modalities are emollients, topical corticosteroids (TCS), and topical calcineurin inhibitors (TCIs). TCS are the mainstay of treatment; however, long-term use of super-potent TCS is not desirable due to a multitude of side effects. Localized cutaneous side effects include skin atrophy, telangiectasia, dyspigmentation, rosacea, dermatitis, acne and impairment of the epidermal barrier.7-11 Tachyphylaxis, or decreased medication efficacy, may also occur as a side effect with repeated administration, causing disease relapse after discontinuation.12,13 While not as prevalent, systemic side effects may occur if the applied TCS penetrates into the circulation; this may only been seen if super-potent TCS are used hastily for long periods with high frequency and large applications. Systemic side effects can be detrimental and include suppression of the hypothalamic-pituitary-adrenal axis (HPA), growth retardation in children, and cataract and glaucoma formation.14-17 Until recently, the only options for patients unresponsive to or requiring frequent application of TCS were oral systemic therapies such as corticosteroids or immunosuppressive medications such as cyclosporine, methotrexate, azathioprine, or mycophenolate mofetil, which are all associated with distinctive, serious systemic side effects.18
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