Cancerous cutaneous ulcers
Conditions
Interventions
Rozex Gel 0.75% will be applied for 7 days, then switched to MR19D6A for 7 days.
Sponsors
Oya Nobuyo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Japanese patients aged 20 years or older who provide informed concent for study participation. 2) Patients with cancerous cutaneous ulcers who expect to survival for more than one month. 3) Patients with an constant size of the ulcer area to be tested, up to approximately 30 g as a daily dose. 4) Patients on continuous use of Rozex Gel 0.75%.
Exclusion criteria
Exclusion criteria: 1) Patients who have received systemic doses of antibiotics at present and within the past two weeks. 2) Patients who have received metronidazole medication other than Rozex Gel 0.75% at present and within the past week. 3) Patients who have received topical antibiotics other than Rozex gel 0.75% to the site of a cancerous cutaneous ulcer at present and within the past week. 4) Patients who have received topical treatment other than Rozex gel 0.75% to the site of a cancerous cutaneous ulcer. 5) Patients who have a plan to change the concomitant therapy for cancer, etc. 6) Patients whose cutaneous ulcer to be applied the study drug is not contacted with cancerous tissues. 7) Patients whose cancerous cutaneous ulcer have reached the bone. 8) Patients with allergy or hypersensitivity to the investigational drug ingredient. 9) Patients using or planning to use ritonavir-containing drugs, disulfiram, coumarin anticoagulants, lithium, 5-fluorouracil, busulfan, cyclosporine, or phenobarbital. 10) Patients who can't abstain from alcohol. 11) Patients with serious cardiovascular disorders, blood disorders, or organic diseases of the brain or spinal cord. 12) Female patients who are pregnant, lactating, or planning to become pregnant during the study period. 13) Patients who participated in the intervention study at present and within the past month. 14) Patients with a known underlying disease or medical condition that is determined to be possible to endanger a subject, confound the evaluation of the study, or preclude a subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events, laboratory tests (hematology, blood biochemistry), vital sign (systlic/diastolic blood pressure, pulse rate), physical findings Pharmacokinetics: plasma concentration of metronidazole, pharmacokinetic parameters Evaluation for usability Evaluation for smell | — |
Contacts
Public ContactClinical Study Unit
Maruishi Pharmaceutical Co., Ltd.
Outcome results
None listed