Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059335) titled 'Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life' on Oct. 10.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - cancerous skin ulcer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate whether metronidazole gel, by reducing bacterial load and odor at cancer-related skin ulcer sites, leads to improved quality of life (QOL) in patients with cancer-related skin ulcers. This will be assessed through a questionnaire survey using the Dermatology Life Quality Index (DLQI) to measure the impact of skin disease on QOL. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals aged 18 years or older at the time consent is obtained 2. Individuals who, after receiving sufficient explanation regarding participation in this study, provided informed consent based on full understanding and of their own free will 3. Patients with cancerous skin ulcers with a life expectancy of 3 months or longer 4. Patients prescribed Metronidazole Gel 0.75% Maruishi Key exclusion criteria - 1. Patients who have used metronidazole 0.75% gel, metronidazole ointment, or other metronidazole products within the past week 2. Patients with a history of hypersensitivity to any component of this drug 3. Patients with organic brain or spinal cord disease (excluding patients with brain or spinal cord tumors) 4. Women within the first three months of pregnancy 5. Patients unable to read or write Japanese due to cognitive impairment, visual impairment, or other reasons 6. Other patients deemed unsuitable as study subjects by the principal investigator Target Size - 33

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 18 Day Date of IRB - 2025 Year 09 Month 24 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066560

Disclaimer: Curated by HT Syndication.