OM202JP Clinical Study of KNP2002

KinoPharma

Status and phase: Completed; Phase 2

Conditions: Common Wart

Treatments: Drug: Placebo of KNP2002; Drug: KNP2002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05896215

OM202JA

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

159 participants in 4 patient groups, including a placebo group

Low dose group

Experimental group

Description:

Topical administration of low dose of KPN2002

Treatment:

Drug: KNP2002

Middle dose group

Experimental group

Description:

Topical administration of middle dose of KPN2002

Treatment:

Drug: KNP2002

High dose group

Experimental group

Description:

Topical administration of high dose of KPN2002

Treatment:

Drug: KNP2002

Placebo group

Placebo Comparator group

Description:

Topical administration of placebo

Treatment:

Drug: Placebo of KNP2002