Pimecrolimus Cream and Tacrolimus Ointment in the Treatment of Atopic Dermatitis: A Pilot Study on Patient Preference
October 2013 | Volume 12 | Issue 10 | Original Article | 1145 | Copyright © 2013
Neh Onumah MDa and Leon Kircik MDb,c
aSkin of all Color LLC, West Windsor, NJ
bMount Sinai Medical Center, New York, NY
cPhysicians Skin Care, PLLC, Louisville, KY
Background: Pimecrolimus cream 1% is approved for mild to moderate atopic dermatitis in children older than two years of age and adults. Tacrolimus ointment 0.03% is approved for moderate to severe atopic dermatitis in the patient population between two to seventeen years of age and Tacrolimus 0.1% ointment for moderate to severe atopic dermatitis in patients 18 years of age and older. However, beyond safety and efficacy, the delivery system or vehicle used in topical treatment formulations is equally important in affecting patient satisfaction, tolerability, and subsequent treatment compliance and hence clinical resolution of active disease.
J Drugs Dermatol. 2013;12(10):1145-1148.
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Atopic dermatitis is a chronic inflammatory skin disorder associated with considerable disease burden due to repeated episodes of clinical exacerbations and remissions.It follows that atopic patients desire a topical treatment that will relieve pruritus, erythema, xerosis, and the presence of active lesions as well as provide long-term disease free intervals. Hydration and the maintenance of skin barrier function are critical factors in the management of these patients.1 However, equally important are ease of use and the aesthetic properties of the topical treatment employed. Specifically, properties of the vehicle in the topical formulation chosen will have an impact on the desirability of the product by the patient and ultimately patient compliance and perception of treatment efficacy.2 Historically, most dermatologists have preferred petrolatum or ointment based topical therapies primarily due to their perceived ease of skin penetration and subsequent expeditious clearance of eczema. However, patient dissatisfaction with the greasy feeling of ointment based formulations typically leads to decreased compliance. Current topical therapies for atopic dermatitis include topical corticosteroids as a first line therapeutic option but not the topical calcineurin inhibitors. The topical calcineurin inhibitors, Tacrolimus ointment (0.03% and 0.1%) and Pimecrolimus cream (1%) are immunomodulators with steroid sparing capabilities. They are approved as second line agents for the intermittent treatment of atopic dermatitis in pediatric and adult patients, aged 2 and older with mild to severe disease. The purpose of this study was to investigate comparative patient satisfaction between ointment based treatment and cream based treatment, specifically Tacrolimus ointment versus Pimecrolimus cream.
We designed a single center randomized (1:1) open label comparison study of Pimecrolimus cream versus Tacrolimus ointment. The study protocol and informed consent form was approved by an institutional review board. A total of 20 male and female subjects with atopic dermatitis as per the Rajka-Hanifin criteria were enrolled (Table 1). Inclusion criteria was moderate atopic dermatitis with 10 to 25 % body surface area involvement. Subjects also had to have failed to respond to first line treatments such as topical steroids by history. Of course, subjects had to understand and comply with the requirements of the study and sign informed consent/HIPAA authorization forms.
Criteria for exclusion of patients included a history of known hypersensitivity or idiosyncratic reaction to any components of the study drug, female subjects of childbearing age who are pregnant (positive urine test), breast-feeding, or not using a reliable method of birth control, and uncontrolled chronic disease such as diabetes or an underlying medical condition that precludes study participation based on investigator discretion. Subjects were also excluded if they participated in a drug study within one month of the baseline visit, had a skin disease at presentation (ie, erythroderma or skin infection of the affected area) which could interfere with the diagnosis or evaluation of atopic dermatitis, had evident history of drug or alcohol abuse within the past 5 years, or known non-compliance with medical treatment or unreliability. No washout was required for this study since efficacy was not a primary end point.
In order to circumvent treatment group allocation bias, all enrolled subjects were randomized to one of two study treatment