title: Safe and effective deodorization of malodorous fungating tumors using topical metronidazole 0.75 % gel (GK567): a multicenter, open-label, phase III study (RDT.07.SRE.27013).
abstract: Malignant fungating tumors are neoplastic tumors associated with skin ulcers, which are susceptible to microbial colonization. Bacterial infection and proliferation may lead to malodor causing distress to patients. Metronidazole-an effective agent against anaerobes-may contribute to deodorization and improvement in quality of life (QOL). This study investigated the efficacy and safety of topical metronidazole 0.75 % gel for alleviation of malodor in anaerobically infected fungating neoplastic tumors.
  
  
  
  This was a multicenter, open-label, non-controlled, phase III study including subjects aged 20 years or older with cutaneous fungating tumors releasing malodor (minimum score of 2 (mildly offensive smell) on a scale from 0 (no smell) to 4 (extremely offensive smell) based on investigator's assessment). Subjects applied metronidazole 0.75 % gel once or twice daily at the investigator's discretion for 14 days. Success was defined as an odor score of 0 or 1 at day 14, as assessed by the investigator. Patient satisfaction was assessed using a satisfaction questionnaire. Adverse events (AEs) that occurred after application of metronidazole 0.75 % gel were also reported.
  
  
  
  A total of 21 subjects at a median age of 65.0 years were enrolled. The success rate of deodorization at day 14 was 95.2 % (20/21 subjects). The patient satisfaction assessment showed that 71.4 % (15/21) of subjects were markedly or moderately improved. The treatment was well tolerated with only two AE cases of skin neoplasm bleeding (one mild and one moderate).
  
  
  
  Metronidazole 0.75 % gel is an effective and safe treatment for deodorization of malodorous fungating tumors.
authors.affiliation: Education and Research Center for Clinical Pharmacy, Showa Pharmaceutical University, 3-3165 Higashi-Tamagawagakuen, Machida-shi, Tokyo, 194-8543, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Department of Breast Endocrine Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Arata
authors.initials: A
authors.lastname: Shimo
authors.affiliation: Department of Breast Endocrine Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Kouichiro
authors.initials: K
authors.lastname: Tsugawa
authors.affiliation: Department of Surgery, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.affiliation: Department of Breast Surgical Oncology, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan.
authors.forename: Hideko
authors.initials: H
authors.lastname: Yamauchi
authors.affiliation: Galderma K.K., Shinjuku Grand Tower 34F, 8-17-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-6134, Japan. eriko.miyai@galderma.com.
authors.forename: Eriko
authors.initials: E
authors.lastname: Miyai
authors.affiliation: Galderma K.K., Shinjuku Grand Tower 34F, 8-17-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-6134, Japan.
authors.forename: Kimitoshi
authors.initials: K
authors.lastname: Takemura
authors.affiliation: Galderma K.K., Shinjuku Grand Tower 34F, 8-17-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-6134, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Ikoma
authors.affiliation: Department of Surgery, Division of Breast Surgical Oncology, Showa University Hospital, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009812:Odorants / Q000517:prevention & control; D017060:Patient Satisfaction; D011788:Quality of Life; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D012883:Skin Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole
keywords: Clinical trial; Malodorous fungating tumors; Odor; Skin ulcer; Topical metronidazole