JRCT ID: jRCT2031200142
Registered date:09/10/2020
A double-blind, placebo-controlled study of HP-5070 in patients with primary hyperhidrosis
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Primary local hyperhidrosis |
Date of first enrollment | 19/10/2020 |
Target sample size | 260 |
Countries of recruitment | |
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 |
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Secondary Outcome | HDSS (Hyperhidrosis Disease Severity Scale) DLQI (Dermatology Life Quality Index) score Adverse events |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Office Customer Service |
Address | 2-4-1 Marunouchi, Chiyoda-ku, Tokyo Tokyo Japan 100-6330 |
Telephone | +81-120-381332 |
sodanshitsu@hisamitsu.co.jp | |
Affiliation | Hisamitsu Pharmaceutical Co., Inc. |
Scientific contact | |
Name | Office Customer Service |
Address | 2-4-1 Marunouchi, Chiyoda-ku, Tokyo Tokyo Japan 100-6330 |
Telephone | +81-120-381332 |
sodanshitsu@hisamitsu.co.jp | |
Affiliation | Hisamitsu Pharmaceutical Co., Inc. |