UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057230 |
|---|---|
| Receipt number | R000065402 |
| Scientific Title | A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study to Evaluate the Efficacy and Safety of PCP/MOF-Coated T-Shirts with Axillary Odor-Specific Adsorption in Patients with Osmidrosis. |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2025/09/09 11:09:36 |
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Basic information
Public title
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study to Evaluate the Efficacy and Safety of PCP/MOF-Coated T-Shirts with Axillary Odor-Specific Adsorption in Patients with Osmidrosis.
Acronym
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study to Evaluate the Efficacy and Safety of PCP/MOF-Coated T-Shirts with Axillary Odor-Specific Adsorption in Patients with Osmidrosis.
Scientific Title
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study to Evaluate the Efficacy and Safety of PCP/MOF-Coated T-Shirts with Axillary Odor-Specific Adsorption in Patients with Osmidrosis.
Scientific Title:Acronym
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Comparative Study to Evaluate the Efficacy and Safety of PCP/MOF-Coated T-Shirts with Axillary Odor-Specific Adsorption in Patients with Osmidrosis.
Region
| Japan |
Condition
Condition
Osmidrosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Osmidrosis -specific adsorbed PCP/MOF processed T-shirts in patients with Osmidrosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLQI or CDLQI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
2weeks
PCP/MOF-Coated T-Shirts
Interventions/Control_2
2weeks
Placebo T-shirt
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are 15 years old or older at the time of obtaining consent.
(2) Patients diagnosed with Osmidrosis.
(3) Patients whose axillary odor score on the six-step odor intensity scale is judged to be 2 or higher by the principal investigator or a designated researcher at the time of enrollment.
Key exclusion criteria
(1) Patients with severe* cardiovascular, hepatic, renal, pulmonary, hematologic diseases, or other complications deemed inappropriate for participation in the clinical study.
*Severity will be determined based on the "Severity Classification Criteria for Adverse Drug Reactions" (Notification No. 80 by the Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare) and the "Common Terminology Criteria for Adverse Events v5.0 Japanese Translation (CTCAE v5.0-JCOG)."
(2) Patients with a history of or concurrent malignant tumors.
However, patients with a history of malignancy who have been treatment-free and recurrence-free for at least five years at the time of consent acquisition, or those who have undergone curative treatment for cervical intraepithelial carcinoma at the time of consent acquisition, may be included in the clinical study.
(3) Patients who have undergone or are currently undergoing any of the following treatments within the specified period:
Laser hair removal, IPL (Intense Pulsed Light), or other axillary hair removal treatments within 24 weeks (168 days) before the enrollment date
Systemic antibiotics (oral or injectable medications with systemic effects) within 4 weeks (28 days) before the enrollment date
Topical medications applied to the axilla (including over-the-counter drugs) within 2 weeks (14 days) before the enrollment date
(4) Patients who, in the judgment of the principal investigator or a designated researcher, have odors other than axillary odor that may affect odor evaluation.
(5) Patients who have not completed at least 120 days since the last dose of an investigational drug in another clinical study or post-marketing clinical trial, or those currently participating in another clinical study or post-marketing clinical trial.
(6) Pregnant or breastfeeding women, women who may be pregnant, or women who do not intend to use appropriate contraception as directed by their physician during the study period.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
yito@keio.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
Homepage URL
yito@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Blisxia Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.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 | 03 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065402
