A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Placebo; KX2-391 Ointment 1%
Intervention description: Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.; The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.
Intervention MeSH terms: Tirbanibulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study tested KX2-391 Ointment 1% against a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All Central Vendors and the sponsor were masked. The sponsor was unblind at the end of Day 57.
Enrollment: 351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis; Keratosis; Keratosis, Actinic; Skin Diseases; Actinic Keratoses; Precancerous Conditions; Neoplasms

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females greater than or equal to (≥) 18 years old

          2. A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and
             discrete AK lesions

          3. Participants who in the judgment of the Investigator, are in good general health

          4. 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.

          5. 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.

          6. 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

          7. Willing to avoid excessive sun or UV exposure

          8. Able to comprehend and are willing to sign the informed consent form (ICF).

        Exclusion Criteria

          1. Clinically atypical and/or rapidly changing AK lesions on the treatment area

          2. Location of the selected area is:

               -  On any location other than the face or scalp

               -  Within 5 cm of an incompletely healed wound

               -  Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
                  (SCC)

          3. Been previously treated with KX2-391 Ointment

          4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to
             Day 57

          5. 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

          6. Use of the following therapies and/or medications within 2 weeks prior to the
             Screening visit:

               -  Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical
                  excision, curettage, dermabrasion, medium or greater depth chemical peel, laser
                  resurfacing) within the treatment area or within 2 cm of the selected treatment
                  area

               -  Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as
                  alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light
                  chemical peels within the treatment area or within 2 cm of the selected treatment
                  area

               -  Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or
                  topical steroids within the treatment area or within 2 cm of the selected
                  treatment area; artificial tanners within the treatment area or within 5 cm of
                  the selected treatment area

          7. Use of the following therapies and/or medications within 4 weeks prior to the
             Screening visit:

               -  Treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg,
                  cyclophosphamide, vinblastine, chlorambucil, methotrexate) or
                  interferons/interferon inducers

               -  Treatment with systemic medications that suppress the immune system (eg,
                  cyclosporine, prednisone, methotrexate, alefacept, infliximab)

          8. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months
             prior to the Screening visit

          9. A history of sensitivity and/or allergy to any of the ingredients in the study
             medication

         10. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring,
             open wounds) that, in the opinion of the Investigator, might interfere with the study
             conduct or evaluations, or which exposes the participants to unacceptable risk by
             study participation

         11. 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

         12. Females who are pregnant or nursing

         13. Participated in an investigational drug trial during which an investigational study
             medication was administered within 30 days or 5 half-lives of the investigational
             product, whichever is longer, before dosing