Common WartPhase 2NCT05896215
OM202JP Clinical Study of KNP2002
A Phase 2 study testing KNP2002 in people with Common Wart, run by KinoPharma Inc. at 15 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Common Wart
- What is being tested?
- KNP2002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 15 sitesJapan
- Study dates
- 12 Jun 2023to 27 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Tsunoda Clinic
Arakawa-Ku, Tokyo, 116-0003
Tetsuya Dermatology
Himeji, Hyōgo, 672-8084
Sugisawa Dermatology Clinic
Katsushika-ku, Tokyo, 125-0041
Igarashi Clinic
Kita-ku, Tokyo, 115-0045
Takashima Dermatology
Kobe, Hyōgo, 657-0027
Nishino Dermatology Clinic
Kobe, Hyōgo, 657-0065
Maruyama Dermatology Clinic
Koto-Ku, Tokyo, 136-0074
Kawaharamachi Dermatology
Maebashi, Gunma, 371-0046
Todoroki Dermatology Clinic
Nakano-Ku, Tokyo, 164-0001
Hayami Dermatology
Osaka, 537-0013
Okawa Dermatology Clinic
Sakai, Osaka, 593-8301
Okuda Dermatology Clinic
Setagaya-Ku, Tokyo, 157-0062
Sugai Dermatology Parkside Clinic
Utsunomiya, Tochigi, 321-2471
Queen's Square, Dermatology, Allergy
Yokohama, Kanagawa, 220-6208
Asai Dermatology Clinic
Yokohama, Kanagawa, 240-0013
About this study
Official title: A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)
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.
- Conditions
- Common Wart
- Being tested
- KNP2002, Placebo of KNP2002
- Keywords
- Common Wart
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNP2002Drug
Also called KV-0132
Dairy topical administration for 12 weeks
Placebo of KNP2002Drug
Dairy topical administration for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Topical administration of low dose of KPN2002 Receives: Drug: KNP2002 |
| Middle dose group | Experimental | Topical administration of middle dose of KPN2002 Receives: Drug: KNP2002 |
| High dose group | Experimental | Topical administration of high dose of KPN2002 Receives: Drug: KNP2002 |
| Placebo group | Placebo comparator | Topical administration of placebo Receives: Drug: Placebo of KNP2002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wart area
Percent change in wart area from baseline
Measured: At 16 weeks after starting administration
Secondary outcomes (3)
Change in wart area over time
Percent change in wart area from baseline
Measured: At 4, 8, 12, and 16 weeks after starting administration
Wart improvement rate
Wart improvement rate categorized by rate of change in wart area
Measured: At 4, 8, 12, and 16 weeks after starting administration
Wart disappearance rate
Proportion of patients with warts disappearing
Measured: Up to 16 weeks after starting administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start12 Jun 2023
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- KinoPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896215
- Sponsor's protocol ID
- OM202JA
- Status last verified
- Apr 2024
- First submitted
- 31 May 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)
- ClinicalTrials.gov ID
- NCT05896215
- Acronym / sponsor ID
- OM202JA
- Conditions
- Common Wart
- Keywords
- Common Wart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- KinoPharma Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: KNP2002Topical administration of low dose of KPN2002 |
| Middle dose group | Experimental | Drug: KNP2002Topical administration of middle dose of KPN2002 |
| High dose group | Experimental | Drug: KNP2002Topical administration of high dose of KPN2002 |
| Placebo group | Placebo comparator | Drug: Placebo of KNP2002Topical administration of placebo |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KNP2002Also: KV-0132Dairy topical administration for 12 weeks | Drug | High dose group, Low dose group, Middle dose group |
| Placebo of KNP2002Dairy topical administration for 12 weeks | Drug | Placebo group |
Primary outcome
Change in wart area
Time frame: At 16 weeks after starting administration
Percent change in wart area from baseline
3 secondary outcomes
Change in wart area over time
Time frame: At 4, 8, 12, and 16 weeks after starting administration
Wart improvement rate
Time frame: At 4, 8, 12, and 16 weeks after starting administration
Wart disappearance rate
Time frame: Up to 16 weeks after starting administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Common Wart
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Not yet recruitingPhase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Common Warts, Common Warts (Verruca Vulgaris)
Recruiting
Liquid Nitrogen Cryotherapy Versus CO₂ Laser for Palmoplantar Warts
Palmoplantar Warts
Not yet recruitingPhase 3
Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
Plantar Wart
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KNP2002 in people with Common Wart, run by KinoPharma Inc. at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wart area (time frame: At 16 weeks after starting administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.