Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Investigational Treatment; Active comparator
Intervention description: Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.; Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Actinic keratosis, patients, topical, lesion count, clearance rate

Summary:

      This is a randomized, vehicle controlled, active comparator, parallel group, study with a
      total duration of 24 weeks including screening and follow-up. Study drug is applied topically
      for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study
      endpoints are blinded to treatment allocation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75
             years (at the time of the screening visit), and in general good health as determined
             by past medical history, physical examination, vital signs, electrocardiogram, and
             laboratory tests at screening

          -  Patients with at least five clinically typical, visible or palpable non-hyperkeratotic
             AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total
             of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears)
             and/or balding scalp

          -  Presence of at least one additional visible or palpable non hyperkeratotic AK lesion
             outside of the selected area amenable to the collection of a skin biopsy, and located
             at least at 2 cm from the limits of the area to receive treatment

          -  Male patients had to agree to use adequate contraception for the duration of the
             study.

        Key Exclusion Criteria:

          -  Known hypersensitivity to any constituents of the study drugs (including local
             anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of
             similar chemical classes or history of serious allergic reaction.

          -  Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible
             confounding skin conditions on face or balding scalp even outside of the treatment
             area.

          -  Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma,
             squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if
             completely surgically removed.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  History of hypertrophic scarring.

          -  Concurrent disease that suppresses the immune system.