OM202JP Clinical Study of KNP2002

Study Overview
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Brief Summary
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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.

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

Conditions
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Common Wart

Intervention / Treatment
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* Drug: KNP2002
* Drug: Placebo of KNP2002


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>Topical administration of low dose of KPN2002 | Drug: KNP2002<br>* Dairy topical administration for 12 weeks<br>* Other names: KV-0132;|
| Experimental: Middle dose group<br>Topical administration of middle dose of KPN2002 | Drug: KNP2002<br>* Dairy topical administration for 12 weeks<br>* Other names: KV-0132;|
| Experimental: High dose group<br>Topical administration of high dose of KPN2002 | Drug: KNP2002<br>* Dairy topical administration for 12 weeks<br>* Other names: KV-0132;|
| Placebo Comparator: Placebo group<br>Topical administration of placebo | Drug: Placebo of KNP2002<br>* Dairy topical administration for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wart area | Percent change in wart area from baseline | At 16 weeks after starting administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wart area over time | Percent change in wart area from baseline | At 4, 8, 12, and 16 weeks after starting administration | 
| Wart improvement rate | Wart improvement rate categorized by rate of change in wart area | At 4, 8, 12, and 16 weeks after starting administration | 
| Wart disappearance rate | Proportion of patients with warts disappearing | Up to 16 weeks after starting administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Wart