Clinical trial NCT05896215: OM202JP Clinical Study of KNP2002
Official title: A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Wart
Keywords: Common Wart
Lead sponsor: KinoPharma Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 159
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in wart area
timeFrame: At 16 weeks after starting administration
Secondary outcomes:
measure: Change in wart area over time
timeFrame: At 4, 8, 12, and 16 weeks after starting administration
measure: Wart improvement rate
timeFrame: At 4, 8, 12, and 16 weeks after starting administration
measure: Wart disappearance rate
timeFrame: Up to 16 weeks after starting administration
Other outcomes:
Locations:
city: Maebashi
country: Japan
facility: Kawaharamachi Dermatology
state: Gunma
city: Himeji
country: Japan
facility: Tetsuya Dermatology
state: Hyogo
city: Kobe
country: Japan
facility: Takashima Dermatology
state: Hyogo
city: Kobe
country: Japan
facility: Nishino Dermatology Clinic
state: Hyogo
city: Yokohama
country: Japan
facility: Queen's Square, Dermatology, Allergy
state: Kanagawa
city: Yokohama
country: Japan
facility: Asai Dermatology Clinic
state: Kanagawa
city: Sakai
country: Japan
facility: Okawa Dermatology Clinic
state: Osaka
city: Utsunomiya
country: Japan
facility: Sugai Dermatology Parkside Clinic
state: Tochigi
city: Arakawa-Ku
country: Japan
facility: Tsunoda Clinic
state: Tokyo
city: Katsushika-Ku
country: Japan
facility: Sugisawa Dermatology Clinic
state: Tokyo
city: Kita-Ku
country: Japan
facility: Igarashi Clinic
state: Tokyo
city: Koto-Ku
country: Japan
facility: Maruyama Dermatology Clinic
state: Tokyo
city: Nakano-Ku
country: Japan
facility: Todoroki Dermatology Clinic
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Okuda Dermatology Clinic
state: Tokyo
city: Osaka
country: Japan
facility: Hayami Dermatology
Study officials:
References: