JRCT ID: jRCT2031230115
Registered date:07/06/2023
A phase II clinical trial of KNP2002 ointment in patients with common warts
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Common warts |
Date of first enrollment | 12/06/2023 |
Target sample size | 160 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | The following 4 groups will be administered, and KNP2002 is administered repeatedly for 12 weeks. KNP2002 high dose KNP2002 moderate dose group KNP2002 low dose group Placebo group |
Outcome(s)
Primary Outcome | 1. Safety evaluation items Adverse event 2. Efficacy endpoints Wart area change from the start of administration (at endpoint) |
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Secondary Outcome | 1. Change in wart area over time 2. Wart disappearance rate 3. Wart improvement rate |
Key inclusion & exclusion criteria
Age minimum | >= 15age old |
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Age maximum | < 50age old |
Gender | Both |
Include criteria | 1. Subjects aged 15 to 49 at the time of obtaining consent 2. Subjects with typical common warts on the upper extremities or lower extremities excluding the soles of the feet. 3. Subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration 4. Subjects who have given their voluntary written consent to participate in this clinical trial |
Exclude criteria | 1. Subjects with 5 or more warts due to human papillomavirus (HPV) infection on the upper or lower limbs 2. Subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts 3. Subjects with a history of allergy to topical skin preparations 4. Subjects with a history of malignant tumor within 5 years before administration of study drug 5. Subjects with any of the following diseases Malignant tumor Serious heart disease Poorly controlled diabetes, hypertension 6. Women who are pregnant, may become pregnant, or are breastfeeding. |
Related Information
Primary Sponsor | Sato Katsuhiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Katsuhiko Sato |
Address | 3-11-5 Nihonbashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Tokyo Japan 103-0023 |
Telephone | +81-3-6264-9604 |
k.sato@kinopharma.com | |
Affiliation | KinoPharma Inc. |
Scientific contact | |
Name | Katsuhiko Sato |
Address | 3-11-5 Nihonbashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Tokyo Japan 103-0023 |
Telephone | +81-3-6264-9604 |
k.sato@kinopharma.com | |
Affiliation | KinoPharma Inc. |