A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)

A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study) - A clinical trial to evaluate the efficacy and safety of OSD-001 (a gel formulation containing sirolimus) in patients with primary palmar hyperhidrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020647

Enrollment

Registered

2016-01-25

Start date

2016-02-10

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

Primary palmar hyperhidrosis

Interventions

0.2% sirolimus gel 8weeks 0.4% sirolimus gel 8 weeks Placebo 8weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects who diagnosed as primary hyperhidrosis according to the guideline of Japan Dermatology Association. 2) Subjects who have HDSS score 3 or 4 and have troubles in daily life. 3) Subjects who have 1.0mg/cm2/min or more of sweat amount.

Exclusion criteria

Exclusion criteria: 1)Subjects who received a surgical treatment including the sympathetic nerve interception within 12 months prior to the study-entry . 2)Subjects who received a treatment with Sirolimus, Everolimus or Temsirolimus within 6 months prior to the study-entry. 3) Subjects who received a treatment with botulinum toxin within 12 months prior to the study-entry . 4) Subjects who received a treatment with aluminum chloride solution or iontophoresis within a month prior to the study-entry . 5) Subjects who received a treatment with anticholinergic drug or antihistamine drug within two weeks prior to the study-entry .

Design outcomes

Primary

Measure	Time frame
Improvement ratio of palmar sweating after 8 weeks treatment	—

Secondary

Measure	Time frame
1) Improvement ratio of palmar sweating after 4 weeks treatment 2) Improvement ratio of HDSS score after 4 weeks or 8weeks treatment 3)improvement ratio of DLQI or CDLQI score after 4 weeks or 8 weeks treatment	—

Countries

Japan

Contacts

Public ContactMari Kaneda

Osaka University Hospital Department of Dermatology

mkaneda@derma.med.osaka-u.ac.jp06-6879-5111

Outcome results

None listed

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