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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05896215
Other study ID # OM202JA
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 12, 2023
Est. completion date May 31, 2024

Study information

Verified date April 2024
Source KinoPharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 159
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KNP2002
Dairy topical administration for 12 weeks
Placebo of KNP2002
Dairy topical administration for 12 weeks

Locations

Country Name City State
Japan Tsunoda Clinic Arakawa-Ku Tokyo
Japan Tetsuya Dermatology Himeji Hyogo
Japan Sugisawa Dermatology Clinic Katsushika-Ku Tokyo
Japan Igarashi Clinic Kita-Ku Tokyo
Japan Nishino Dermatology Clinic Kobe Hyogo
Japan Takashima Dermatology Kobe Hyogo
Japan Maruyama Dermatology Clinic Koto-Ku Tokyo
Japan Kawaharamachi Dermatology Maebashi Gunma
Japan Todoroki Dermatology Clinic Nakano-Ku Tokyo
Japan Hayami Dermatology Osaka
Japan Okawa Dermatology Clinic Sakai Osaka
Japan Okuda Dermatology Clinic Setagaya-Ku Tokyo
Japan Sugai Dermatology Parkside Clinic Utsunomiya Tochigi
Japan Asai Dermatology Clinic Yokohama Kanagawa
Japan Queen's Square, Dermatology, Allergy Yokohama Kanagawa

Sponsors (1)

Lead Sponsor Collaborator
KinoPharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in wart area Percent change in wart area from baseline At 16 weeks after starting administration
Secondary Change in wart area over time Percent change in wart area from baseline At 4, 8, 12, and 16 weeks after starting administration
Secondary Wart improvement rate Wart improvement rate categorized by rate of change in wart area At 4, 8, 12, and 16 weeks after starting administration
Secondary Wart disappearance rate Proportion of patients with warts disappearing Up to 16 weeks after starting administration
See also
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Not yet recruiting NCT04288817 - Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts Phase 3
Completed NCT03278028 - A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts Phase 2
Completed NCT03812510 - Safety Study of A-101 Topical Solution for the Treatment of Common Warts Phase 3
Recruiting NCT05799157 - Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts Phase 2
Recruiting NCT06214559 - Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts. N/A
Recruiting NCT03977753 - Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts Phase 4
Completed NCT03210337 - A Phase2 of A-101 Topical Solution in Subjects With Common Warts Phase 2
Completed NCT03183765 - Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts Phase 4