Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was
 evaluated in adult participants with a clinical diagnosis of stable, clinically typical
 actinic keratosis (AK) on the face or scalp.
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of
 KX2-391 Ointment administered topically to the face or scalp of participants with AK.

 The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were
 received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood
 samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were
 performed.
Inclusion Criteria:

 1. Males and females ≥18 years old

 2. Clinical diagnosis of stable, clinically typical actinic keratosis

 3. A define treatment area on the face or scalp

 4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy
 for at least 1 year; or must be using highly effective contraception for at least 90
 days prior to treatment with KX2-391 Ointment

 5. Males who have not had a vasectomy must agree to use barrier contraception

 6. Participants who in the judgment of the Investigator, are in good general health

 7. Willing to avoid excessive sun exposure

 8. Able to comprehend and are willing to sign an informed consent form (ICF)

 Exclusion Criteria:

 1. Clinically atypical and/or rapidly changing AK lesions on the treatment area

 2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma
 not on the treatment area that were treated with curative intent and are without
 recurrence

 3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and
 methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1

 4. Used any topical therapies, treatments, or surgical or destructive modalities on the
 treatment area within, at the most 90 days, before Visit 1

 5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the
 treatment area within, at the most 180 days, before Visit 1

 6. A history of sensitivity and/or allergy to any of the ingredients in the study
 medication

 7. A skin disease or condition that, in the opinion of the Investigator, might interfere
 with the study conduct or evaluations, or which exposes the participant to an
 unacceptable risk by study participation

 8. Other significant uncontrolled or unstable medical diseases or conditions that, in the
 opinion of the Investigator, would expose the participant to unacceptable risk by
 study participation

 9. Females who are pregnant or nursing

 10. Participated in an investigational drug trial during which an investigational study
 medication was administered within 14 days or 5 half-lives of the investigational
 product, whichever is longer, before dosing.