Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: Two phase 3, multicenter, randomized, double-blind, placebo-controlled studies

Neil Swanson, Christina Cognata Smith, Mandeep Kaur, Gary Goldenberg

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

BACKGROUND: Imiquimod 3.75% and 2.5% creams were studied for the treatment of actinic keratosis (AK) of the full face or balding scalp, to determine comparable efficacy and tolerability to imiquimod 5% cream. METHODS: In two identical multicenter, randomized, double-blind, placebo controlled studies. Adult subjects with 5 to 20 visible lesions, or palpable AKs in an area that exceeded 25cm2 on either the face or balding scalp were randomized to imiquimod 3.75%, 2.5% or vehicle cream (1:1:1) applied once daily for two 2-week treatment cycles, with a 2-week, no-treatment interval between cycles. Efficacy was assessed 8 weeks posttreatment (End of Study Visit [EOS]). Primary efficacy was rate of complete clearance of AK lesions. Secondary efficacy endpoints were rate of partial clearance at EOS (? 75% reduction in number of AK lesions compared to baseline) and median percent decrease from baseline lesion count. Safety assessments included visual assessment of local skin reactions (LSRs), number and duration of study treatment rest periods required due to intolerant LSRs, adverse events (AEs) and clinical laboratory tests. RESULTS: Overall 479 patients were randomized to imiquimod 3.75%, 2.5%, or vehicle. Complete clearance rates were 35.6%, 30.6%, and 6.3% respectively (both P

Original languageEnglish (US)
Pages (from-to)166-169
Number of pages4
JournalJournal of Drugs in Dermatology
Volume13
Issue number2
StatePublished - 2014

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imiquimod
Actinic Keratosis
Placebos
Scalp
Skin
Therapeutics
Safety

ASJC Scopus subject areas

  • Dermatology

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Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses : Two phase 3, multicenter, randomized, double-blind, placebo-controlled studies. / Swanson, Neil; Smith, Christina Cognata; Kaur, Mandeep; Goldenberg, Gary.

In: Journal of Drugs in Dermatology, Vol. 13, No. 2, 2014, p. 166-169.

Research output: Contribution to journalArticle

Swanson, Neil ; Smith, Christina Cognata ; Kaur, Mandeep ; Goldenberg, Gary. / Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses : Two phase 3, multicenter, randomized, double-blind, placebo-controlled studies. In: Journal of Drugs in Dermatology. 2014 ; Vol. 13, No. 2. pp. 166-169.
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