Clinical trial

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

Name

OM202JA

Description

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 arms

Trial start

2023-06-12

Estimated PCD

2024-05-31

Trial end

2024-05-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

KNP2002

Dairy topical administration for 12 weeks

Arms:

High dose group, Low dose group, Middle dose group

Other names:

KV-0132

Placebo of KNP2002

Dairy topical administration for 12 weeks

Arms:

Placebo group

Size

159

Primary endpoint

Change in wart area

At 16 weeks after starting administration

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 159, 'type': 'ACTUAL'}}

Updated at

2024-04-08

1 organization

2 products

1 indication

Organization

Product

Indication

Product