A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or … (NCT03285477) | Clinical Trial Compass
CompletedPhase 3
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
United States351 participantsStarted 2017-09-18
Plain-language summary
This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females greater than or equal to (≥) 18 years old
✓. A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions
✓. Participants who in the judgment of the Investigator, are in good general health
✓. Females must be postmenopausal \[greater than (\>) 45 years of age with at least 12 months of amenorrhea\], surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse.
✓. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
✓. All participants must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment
✓. Willing to avoid excessive sun or UV exposure
✓. Able to comprehend and are willing to sign the informed consent form (ICF).
Exclusion criteria
✕. Clinically atypical and/or rapidly changing AK lesions on the treatment area
What they're measuring
1
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
✕. Been previously treated with KX2-391 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
✕. 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:
✕. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit