OM202JP Clinical Study of KNP2002

NCT ID: NCT05896215

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-07-27

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.

Detailed Description

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Conditions

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Common Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose group

Topical administration of low dose of KPN2002

Group Type EXPERIMENTAL

KNP2002

Intervention Type DRUG

Dairy topical administration for 12 weeks

Middle dose group

Topical administration of middle dose of KPN2002

Group Type EXPERIMENTAL

KNP2002

Intervention Type DRUG

Dairy topical administration for 12 weeks

High dose group

Topical administration of high dose of KPN2002

Group Type EXPERIMENTAL

KNP2002

Intervention Type DRUG

Dairy topical administration for 12 weeks

Placebo group

Topical administration of placebo

Group Type PLACEBO_COMPARATOR

Placebo of KNP2002

Intervention Type DRUG

Dairy topical administration for 12 weeks

Interventions

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KNP2002

Dairy topical administration for 12 weeks

Intervention Type DRUG

Placebo of KNP2002

Dairy topical administration for 12 weeks

Intervention Type DRUG

Other Intervention Names

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KV-0132

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KinoPharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kawaharamachi Dermatology

Maebashi, Gunma, Japan

Site Status

Tetsuya Dermatology

Himeji, Hyōgo, Japan

Site Status

Takashima Dermatology

Kobe, Hyōgo, Japan

Site Status

Nishino Dermatology Clinic

Kobe, Hyōgo, Japan

Site Status

Queen's Square, Dermatology, Allergy

Yokohama, Kanagawa, Japan

Site Status

Asai Dermatology Clinic

Yokohama, Kanagawa, Japan

Site Status

Okawa Dermatology Clinic

Sakai, Osaka, Japan

Site Status

Sugai Dermatology Parkside Clinic

Utsunomiya, Tochigi, Japan

Site Status

Tsunoda Clinic

Arakawa-Ku, Tokyo, Japan

Site Status

Sugisawa Dermatology Clinic

Katsushika-ku, Tokyo, Japan

Site Status

Igarashi Clinic

Kita-ku, Tokyo, Japan

Site Status

Maruyama Dermatology Clinic

Koto-Ku, Tokyo, Japan

Site Status

Todoroki Dermatology Clinic

Nakano-Ku, Tokyo, Japan

Site Status

Okuda Dermatology Clinic

Setagaya-Ku, Tokyo, Japan

Site Status

Hayami Dermatology

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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OM202JA

Identifier Type: -

Identifier Source: org_study_id

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