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Completed

NCT Number: NCT05896215

OM202JP Clinical Study of KNP2002

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.

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Key information

Conditions

Common Wart DNA Virus Infections Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases Warts

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kawaharamachi Dermatology, Maebashi, Gunma, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KNP2002

Drug

Dairy topical administration for 12 weeks

Other names: KV-0132

Placebo of KNP2002

Drug

Dairy topical administration for 12 weeks

Primary outcomes

  1. Change in wart area

    Time frame: At 16 weeks after starting administration

    Percent change in wart area from baseline

Secondary outcomes

  1. Change in wart area over time

    Time frame: At 4, 8, 12, and 16 weeks after starting administration

    Percent change in wart area from baseline

  2. Wart improvement rate

    Time frame: At 4, 8, 12, and 16 weeks after starting administration

    Wart improvement rate categorized by rate of change in wart area

  3. Wart disappearance rate

    Time frame: Up to 16 weeks after starting administration

    Proportion of patients with warts disappearing

Sponsors and collaborators

Lead sponsor

KinoPharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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