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Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers

Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers - Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016525
Enrollment
12
Registered
2015-02-12
Start date
2015-02-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperhidrosis

Interventions

The bilateral lesions are chosen as the treatment areas. Rapamycin gel is applied on the left lesion, and the gel base is applied on the right lesion. Amount of sweating is measured before applicat

Sponsors

Department of Dermatology Graduate School of Medicine, Osaka University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy volunteers over 20 years of age. 2) Healthy volunteers who can give written consent by themselves in understanding after having received enough explanation on this examination.

Exclusion criteria

Exclusion criteria: 1) A person who cannot carry out this treatment plan. 2) A person who have allergy to macrolide antibiotics. 3) A person who received oral administration of rapamycin or RAD001 within 12 months prior to the study entry. 4) A person who received topical administration of rapamycin or RAD001 within three days prior to the study entry. 5) A person who received topical treatment of aluminum chloride or iontophoresis within one months prior to the study entry. 6) A person who received local injection of Botox within three months prior to the study entry. 7) A person who received sympathectomy within 12 months prior to the study entry. 8) A person during pregnancy or lactation 9) A person who cannot undergo QSART and starch-iodine test 10) A person who were judged unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Skin findings at the site of topical application Subjective findings at the site of topical application Serious adverse events Amount of sweating

Countries

Japan

Contacts

Public ContactMari Wataya-Kaneda

Graduate School of Medicine, Osaka University Department of Dermatology

mkaneda@derma.med.osaka-u.ac.jp06-6879-3031

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026