A double-blind, placebo-controlled study of HP-5070 in patients with primary hyperhidrosis

JRCT ID: jRCT2031200142

Registered date:09/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary local hyperhidrosis
• Date of first enrollment: 19/10/2020
• Target sample size: 260
• Study type: Interventional
• Intervention(s): Transdermal application of HP-5070 (oxybutynin hydrochloride) or placebo

Outcome(s)

• Primary Outcome: The proportion of responders with the defined volume of sweat

Secondary Outcome

HDSS (Hyperhidrosis Disease Severity Scale)
DLQI (Dermatology Life Quality Index) score
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Japanese patients aged 12 years or older
- Patients with a diagnosis of primary local hyperhidrosis
- Patients with involvement of palmar sites

Exclude criteria

- Patients with secondary hyperhidrosis
- Patients with heavy sweating due to climacteric disturbance
- Patients who have undergone surgery for hyperhidrosis (sympathectomy, nerve block, laser surgery, etc.)

Related Information

• Primary Sponsor: Customer Service Office