Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: 50 mg of KX2-391 Ointment 1%; 50 mg of KX2-391 Ointment 1%
Intervention description: Dose: 50 mg; Route of administration: Topical; Dose: 50 mg; Route of administration: Topical
Intervention MeSH terms: Tirbanibulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.