Osmidrosis
Conditions
Interventions
2weeks PCP/MOF-Coated T-Shirts
2weeks Placebo T-shirt
Sponsors
Keio University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLQI or CDLQI | — |
Countries
Japan
Contacts
Public ContactYoshihiro Ito
Keio University School of Medicine Department of Dermatology
Outcome results
None listed