A phase II clinical trial of KNP2002 ointment in patients with common warts

JRCT ID: jRCT2031230115

Registered date:07/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Common warts
• Date of first enrollment: 12/06/2023
• Target sample size: 160
• 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)

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
• 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