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 range20 Years
SexALL
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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
✕. 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
What they're measuring
1
Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions