UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059335 |
|---|---|
| Receipt number | R000066560 |
| Scientific Title | Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/08 14:10:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life
Acronym
Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life
Scientific Title
Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life
Scientific Title:Acronym
Prospective observational study on the effect of metronidazole gel 0.75% "Maruishi" on quality of life
Region
| Japan |
Condition
Condition
cancerous skin ulcer
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
The study aims to investigate changes in odor scores and pain NRS scores.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in DLQI score at day 15
Key secondary outcomes
Odor score on the 15th day, usability survey, adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital East
Division name
Department of Dermatologic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
atakahas@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital East
Division name
Department of Dermatologic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
https://www.ncc.go.jp/jp/about/research_promotion/study/list/index.html
atakahas@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
Tel
04-7133-1111
atakahas@east.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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. Furthermore, the study aims to investigate changes in odor scores and pain NRS scores.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066560
