A randomized, double-blind, placebo-controlled study of clobetasol propionate 0.05% foam in the treatment of nonscalp psoriasis

Authors

  • Mark Lebwohl MD, FACP,

    Corresponding author
    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • Daniel Sherer MD,

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • Ken Washenik MD, PhD,

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • Gerald G. Krueger MD,

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • Alan Menter MD,

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • John Koo MD,

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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  • Steven R. Feldman MD, PhD

    1. From the Departments of Dermatology, Mount Sinai Medical Center, New York; New York University, New York; University of Utah, Utah; Baylor Psoriasis Center, Dallas, Texas; University of California, San Francisco, California; and Wake Forest University School of Medicine, Winston-Salem, North Carolina
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Mark Lebwohl, md, facp Mount Sinai Medical Center One Gustave L. Levy Place New York, NY 10029-6574 E-mail: sinaiderom@aol.com

Abstract

Background Topical corticosteroids are the primary treatment for mild to moderate psoriasis. Foam preparations of corticosteroids offer potential cosmetic and pharmacodynamic advantages over cream and ointment vehicles. A clobetasol propionate foam product is as effective as clobetasol propionate solution in the treatment of scalp psoriasis.

Aim To evaluate the safety and efficacy of clobetasol propionate foam in the treatment of psoriasis involving sites other than the scalp.

Methods Eighty-one subjects with mild to moderate psoriasis were randomized in a 3 : 1 ratio to receive clobetasol propionate foam vs. placebo foam treatment in this double-blind study of psoriasis involving nonscalp sites. The investigator's and subject's global assessment of the response at week 2 (or at the end of treatment) and at week 4 (follow-up) and the severity of erythema, scaling, and plaque thickness were assessed. Safety was assessed from reported adverse events.

Results After 2 weeks of treatment, there was significantly greater improvement with clobetasol propionate foam compared with placebo foam in both investigator's and subject's global assessment of the response (P < 0.0005). The improvement with clobetasol propionate foam was still present at the 4-week follow-up visit. Adverse effects were generally limited to mild to moderate application site reactions. No subjects withdrew because of adverse events.

Conclusions Clobetasol propionate foam is more effective than placebo in the treatment of nonscalp psoriasis. Twice-daily applications are well tolerated, compliance exceeds 90%, cosmetic characteristics are acceptable, and the medication may eliminate the need for separate scalp and body prescriptions.

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