title: Pharmacokinetics of ivermectin applied topically by whole-body bathing method in healthy volunteers.
abstract: As a novel administration method of ivermectin (IVM) for scabies treatment, we proposed a "whole-body bathing method (WBBM)". In this method, the patients would bathe themselves in a bathing fluid containing IVM at an effective concentration. Previously, we demonstrated that WBBM could deliver IVM to the skin but not to the plasma in rats. In the present study, to assess the clinical validity of the method an arm bathing examination (first trial) and a whole-body bathing examination (second trial) were conducted in healthy volunteers. In both the first and second trials, after bathing in fluid containing IVM, the exposure in the stratum corneum was higher compared with that after taking IVM p.o. as reported previously. IVM was not detected in plasma at any sampling point after the whole-body bathing in the second trial. Furthermore no serious adverse events were found. These results in both trials suggest that WBBM can deliver IVM to the human stratum corneum without systemic exposure or serious adverse effects in healthy volunteers, and at concentrations that would be adequate for scabies treatment.
authors.affiliation: Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Miyajima
authors.affiliation: Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Hirota
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Mari
authors.initials: M
authors.lastname: Tashiro
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Noguchi
authors.affiliation: Department of Clinical Pharmaceutical Preformulation, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Yayoi
authors.initials: Y
authors.lastname: Kawano
authors.affiliation: Department of Clinical Pharmaceutical Preformulation, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Takehisa
authors.initials: T
authors.lastname: Hanawa
authors.affiliation: Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kigure
authors.affiliation: Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Taichi
authors.initials: T
authors.lastname: Anata
authors.affiliation: Department of Biopharmaceutics, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Nae
authors.initials: N
authors.lastname: Yuasa
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Machi
authors.initials: M
authors.lastname: Koshino
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Yumi
authors.initials: Y
authors.lastname: Shiraishi
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Yuzawa
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Keita
authors.initials: K
authors.lastname: Akagi
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yoshimasu
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.|Tsubasa Home Care Clinic, Funabashi, Chiba, Japan.
authors.forename: Kuniko
authors.initials: K
authors.lastname: Makigami
authors.affiliation: Department of Medical Safety, Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Chiba, Japan.
authors.forename: Masayo
authors.initials: M
authors.lastname: Komoda
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000977:Antiparasitic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D001494:Baths; D004817:Epidermis / Q000187:drug effects; D064368:Healthy Volunteers; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D012532:Scabies / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000977:Antiparasitic Agents; D007559:Ivermectin
keywords: healthy volunteers; ivermectin; scabies; stratum corneum; whole-body bathing method