A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis… (NCT05231044) | Clinical Trial Compass
CompletedPhase 3
A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp
Japan108 participantsStarted 2021-12-21
Plain-language summary
This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Japanese Males and females ≥20 years old
. A treatment area on the face or scalp that:
. is a contiguous area measured 25 cm2
. contains more than 1 clinically typical, visible, and discrete AK lesions
. Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:
. medical history
. physical examination (PE) findings
. vital signs
Exclusion criteria
. Clinically atypical and / or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and / or cutaneous horn
. Location of the treatment area is:
. Been previously treated with KX01 Ointment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions
. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit
. Use of the following therapies and / or medications within 2 weeks prior to the Screening visit:
. Use of the following therapies and / or medications within 4 weeks prior to the Screening visit: