OM202JP Clinical Study of KNP2002

Common Wart Clinical Trial

Official title:

A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05896215
• Other study ID #: OM202JA
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 12, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: KinoPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate safety and efficacy of KNP2002 in patients with common warts aged 15 to 50 years old.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 159
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Subjects aged 15 to 49 years old

• Subjects with common warts on the upper or lower limb

• Subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration

• Subjects who have given their voluntary written consent to participate in this clinical trial

Exclusion Criteria:

• Subjects with 5 or more warts on the upper or lower limbs

• Subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts

• Subjects with a history of allergy to topical skin preparations

• Subjects with a history of malignant tumor within 5 years before administration of study drug

• Subjects with any of the following diseases: Malignant tumor; Serious heart disease; Poorly controlled diabetes/hypertension

• Women who are pregnant, may become pregnant, or are breastfeeding

Related Conditions & MeSH terms

• Common Wart
• Warts

Intervention

Drug:
• KNP2002
Dairy topical administration for 12 weeks
• Placebo of KNP2002
Dairy topical administration for 12 weeks

Locations

Country	Name	City	State
Japan	Tsunoda Clinic	Arakawa-Ku	Tokyo
Japan	Tetsuya Dermatology	Himeji	Hyogo
Japan	Sugisawa Dermatology Clinic	Katsushika-Ku	Tokyo
Japan	Igarashi Clinic	Kita-Ku	Tokyo
Japan	Nishino Dermatology Clinic	Kobe	Hyogo
Japan	Takashima Dermatology	Kobe	Hyogo
Japan	Maruyama Dermatology Clinic	Koto-Ku	Tokyo
Japan	Kawaharamachi Dermatology	Maebashi	Gunma
Japan	Todoroki Dermatology Clinic	Nakano-Ku	Tokyo
Japan	Hayami Dermatology	Osaka
Japan	Okawa Dermatology Clinic	Sakai	Osaka
Japan	Okuda Dermatology Clinic	Setagaya-Ku	Tokyo
Japan	Sugai Dermatology Parkside Clinic	Utsunomiya	Tochigi
Japan	Asai Dermatology Clinic	Yokohama	Kanagawa
Japan	Queen's Square, Dermatology, Allergy	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
KinoPharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wart area	Percent change in wart area from baseline	At 16 weeks after starting administration
Secondary	Change in wart area over time	Percent change in wart area from baseline	At 4, 8, 12, and 16 weeks after starting administration
Secondary	Wart improvement rate	Wart improvement rate categorized by rate of change in wart area	At 4, 8, 12, and 16 weeks after starting administration
Secondary	Wart disappearance rate	Proportion of patients with warts disappearing	Up to 16 weeks after starting administration