title: A double-blind, placebo-controlled study of the safety and efficacy of vitamin K1 ointment for the treatment of patients with cetuximab-induced acneiform eruption.
abstract: A double-blind, placebo-controlled study evaluating the efficacy and safety of vitamin K1 ointment for the treatment of patients with cetuximab-induced acneiform eruption has started. Vitamin K1 ointment and placebo are applied twice daily for 8 consecutive weeks after the development of acneiform eruptions. Vitamin K1 ointment is applied in the middle of one side (face, neck or chest) and placebo is applied to the other side. The primary endpoint is the regression rate of acneiform eruptions on right- and left-side lesions in the same patient, compared with baseline at the final evaluation in the 10-week trial. The secondary endpoints include adverse events of acneiform eruption and other adverse events.
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital, Tokyo, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. hhashimo@ncc.go.jp
authors.forename: Hironobu
authors.initials: H
authors.lastname: Hashimoto
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwasa
authors.forename: Takako
authors.initials: T
authors.lastname: Yanai
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Honma
authors.forename: Ken
authors.initials: K
authors.lastname: Kato
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hamaguchi
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Namikawa
authors.forename: Arata
authors.initials: A
authors.lastname: Tsutsumida
authors.forename: Naoya
authors.initials: N
authors.lastname: Yamazaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamamoto
mesh_terms: D017486:Acneiform Eruptions / Q000139:chemically induced*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068818:Cetuximab; D002985:Clinical Protocols; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D009824:Ointments / Q000627:therapeutic use*; D011379:Prognosis; D010837:Vitamin K 1 / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D009824:Ointments; D014815:Vitamins; D010837:Vitamin K 1; D000068818:Cetuximab