A long-term extension study of HP-5070 in patients with primary hyperhidrosis

JRCT ID: jRCT2031200143

Registered date:09/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary local hyperhidrosis
• Date of first enrollment: 10/11/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Transdermal application of HP-5070 (oxybutynin hydrochloride)

Outcome(s)

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

Key inclusion & exclusion criteria

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

Include criteria

Patients who continued into the extension
- Japanese patients with primary local hyperhidrosis who completed the prior study
- Patients wishing to continue to receive HP-5070 after participating in the prior study

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

Exclude criteria

Patients who continued into the extension
- Patients with a resting pulse rate of less than 45 beats per minute or more than 90 beats per minute measured during the pre-observation period of the prior study
- Patients with a QTcF of 450 msec or more on a 12-lead ECG measured during the pre-observation period of the prior study
- Patients with abnormal waveforms on a 12-lead ECG measured during the pre-observation period of the prior study

New patients
- 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