NCT05896215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

May 31, 2023

Last Update Submit

September 26, 2024

Conditions

Common Wart

Keywords

Common Wart

Outcome Measures

Primary Outcomes (1)

  • Change in wart area

    Percent change in wart area from baseline

    At 16 weeks after starting administration

Secondary Outcomes (3)

  • Change in wart area over time

    At 4, 8, 12, and 16 weeks after starting administration

  • Wart improvement rate

    At 4, 8, 12, and 16 weeks after starting administration

  • Wart disappearance rate

    Up to 16 weeks after starting administration

Study Arms (4)

Low dose group

EXPERIMENTAL

Topical administration of low dose of KPN2002

Drug: KNP2002

Middle dose group

EXPERIMENTAL

Topical administration of middle dose of KPN2002

Drug: KNP2002

High dose group

EXPERIMENTAL

Topical administration of high dose of KPN2002

Drug: KNP2002

Placebo group

PLACEBO COMPARATOR

Topical administration of placebo

Drug: Placebo of KNP2002

Interventions

KNP2002DRUG

Dairy topical administration for 12 weeks

Also known as: KV-0132
High dose groupLow dose groupMiddle dose group
Placebo of KNP2002DRUG

Dairy topical administration for 12 weeks

Placebo group

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Kawaharamachi Dermatology

Maebashi, Gunma, 371-0046, Japan

Location

Tetsuya Dermatology

Himeji, Hyōgo, 672-8084, Japan

Location

Takashima Dermatology

Kobe, Hyōgo, 657-0027, Japan

Location

Nishino Dermatology Clinic

Kobe, Hyōgo, 657-0065, Japan

Location

Queen's Square, Dermatology, Allergy

Yokohama, Kanagawa, 220-6208, Japan

Location

Asai Dermatology Clinic

Yokohama, Kanagawa, 240-0013, Japan

Location

Okawa Dermatology Clinic

Sakai, Osaka, 593-8301, Japan

Location

Sugai Dermatology Parkside Clinic

Utsunomiya, Tochigi, 321-2471, Japan

Location

Tsunoda Clinic

Arakawa-Ku, Tokyo, 116-0003, Japan

Location

Sugisawa Dermatology Clinic

Katsushika-ku, Tokyo, 125-0041, Japan

Location

Igarashi Clinic

Kita-ku, Tokyo, 115-0045, Japan

Location

Maruyama Dermatology Clinic

Koto-Ku, Tokyo, 136-0074, Japan

Location

Todoroki Dermatology Clinic

Nakano-Ku, Tokyo, 164-0001, Japan

Location

Okuda Dermatology Clinic

Setagaya-Ku, Tokyo, 157-0062, Japan

Location

Hayami Dermatology

Osaka, 537-0013, Japan

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

June 12, 2023

Primary Completion

July 27, 2024

Study Completion

July 27, 2024

Last Updated

September 27, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(15)