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October 2012

1194

VOLUME 11 • ISSUE 10

Copyright © 2012

Original Article

Journal of Drugs in Dermatology

The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream

Leon H. Kircik MD FAADa and James Q. Del Rosso DO FAOCDb

aIndiana University School of Medicine, Indianapolis, IN Mount Sinai Medical Center, New York, NY; DermResearch, PLLC, Louisville, KY bValley Hospital Medical Center, Las Vegas, NV; Touro University College of Osteopathic Medicine, Henderson, NV Las Vegas Skin & Cancer Clinics, Dermatology and Cutaneous Surgery, Las Vegas and Henderson, NV

Abstract

Objective: Study results evaluating the efficacy and safety of clocortolone pivalate 0.1% cream in the treatment of adults, young children, and infants with inflammatory facial dermatoses are reported in this article. Clocortolone pivalate 0.1% cream, indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, is a mid-potency topical corticosteroid (Class 4) that has been studied and used extensively to treat a variety of corticosteroid-responsive inflammatory dermatoses, many of which often involve facial skin in both adults and children.
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.

J Drugs Dermatol. 2012;11(10):1194-1198.

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INTRODUCTION

Seborrheic dermatitis and atopic dermatitis are well recognized as common facial dermatoses. Both irritant and allergic contact dermatitis may involve any anatomic location, with facial involvement sometimes noted depending on the contactants involved and patterns of cutaneous exposure. Facial psoriasis is perceived to be relatively uncommon by comparison, however, facial skin may be affected in 17% to 46% of patients with psoriasis.1 Atopic dermatitis flares may sometimes be localized to the eyelids and/or the post auricular region, with or without involvement of other facial areas.2

The most commonly encountered skin disorders that fall under the umbrella of corticosteroid-responsive dermatoses are seborrheic dermatitis, psoriasis (plaque type), and eczematous dermatoses such as atopic dermatitis and contact dermatitis, As these entities are very common, therapies for these disorders are well established and widely published. However, data are more limited on the treatment of only facial involvement for most of these disorders. Even with larger clinical trials, subset analyses evaluating efficacy and safety with treatment of the face alone is not typically reported. Therapeutic response and adverse event profiles related to specific treatments of facial skin involve unique challenges, as the patient's desire for a more rapid response is usually greater, and visible adverse reactions are more psychologically bothersome to many patients, especially those that may be persistent.

Facial skin is different from other body locations in a number of ways.3 The skin on the face is thinner and pilosebaceous units are much more numerous. Due to regular exposure of facial skin to environmental factors, climatic changes, and many contactants, such as products used for personal hygiene, skin care,

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