hyperhidrosis
Conditions
Interventions
The bilateral lesions are chosen as the treatment areas. 0.2% rapamycin gel is applied on the right lesion, and the gel base is applied on the left lesion twice a day for 6 weeks.
The bilateral lesi
Sponsors
Department of Dermatology Graduate School of Medicine, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are definitively diagnosed with primary hyperhidrosis according to the diagnostic criteria described by Japanese dermatological association. 2) Patients who couldn't receive effective treatments. 3) Patients who have bilateral symmetrical lesions. 4) Patients over 15 years of age. 5) Patients who can give written consent by themselves in understanding after having received enough explanation on this examination. If the patients were under 20 years old, both written consent from the person with parental authority and written assent from the patient must be obtained.
Exclusion criteria
Exclusion criteria: 1) Patients who cannot carry out this treatment plan. 2) Patients who have allergy to macrolide antibiotics. 3) Patients who received oral or topical administration of rapamycin or RAD001 within 12 months prior to the study entry. 4) Patients who received topical treatment of aluminum chloride or iontophoresis within one months prior to the study entry. 5) Patients who received local injection of Botox within three months prior to the study entry. 6) Patients who received sympathectomy within 12 months prior to the study entry. 7) Patients during pregnancy or lactation 8) Patients who cannot undergo QSART and starch-iodine test 9) Patients who were judged unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin findings at the site of topical application Blood test results Blood level of rapamycin Serious adverse events The measurement of the perspiration amount photograph | — |
Secondary
| Measure | Time frame |
|---|---|
| Histological findings in biopsy specimens of the lesions Improvement of subjective symptoms Patient satisfaction The measurement of the perspiration amount and area by Starch-Iodine Test | — |
Countries
Japan
Contacts
Public ContactMari Wataya-Kaneda
Graduate School of Medicine, Osaka University Department of Dermatology
Outcome results
None listed