Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ingenol mebutate gel 0.015%; ingenol mebutate gel 0.05%
Intervention description: -Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days; -Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Korean

Summary:

      This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp
      & 0.05% on trunk and extremities in Korean patient with actinic keratosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥ 19 years

          2. Histopathologically diagnosed AK patients with at least 1 macroscopic and discrete
             lesion within a contiguous 25 cm2 (e.g. 5 cm x 5 cm) of treatment area

          3. The treatment area including the lesion must be accessible to apply the
             investigational product. However, the lesions on lips, mucosa, outer ear (concha) and
             those around eyes are excluded.

          4. Subjects who signed the written informed consent prior to perform any study-related
             procedures or assessments, including photographs of their treatment area for
             documentation and efficacy assessment.

        Exclusion Criteria:

          1. Hypersensitivity to any components of the investigational product

          2. History or evidence of skin conditions that could interfere with evaluation of the
             investigational product(e.g., eczema, unstable psoriasis, xeroderma pigmentosa,
             inflammatory or infectious disease around the selected treatment area)

          3. Unhealed wound within 5 cm, or basal cell carcinoma or squamous cell carcinoma within
             10 cm from the selected treatment area.

          4. Subjects who received or expected to receive any of the following pharmacotherapy and
             non-pharmacotherapy or procedures during the treatment and follow-up period

          5. Subjects who have following disorder or abnormal laboratory result

          6. Pregnant, lactating, and childbearing potential women who are unwilling to practice
             effective contraception; for example, oral contraceptives, hormonal methods, placement
             of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e.,
             condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male
             sterilization, and abstinence.

          7. Subjects who previously underwent another clinical trial within 30 days or 5-times the
             half-life of previous investigational product prior to baseline (the longer period of
             time must be considered).

          8. Other conditions by investigator's discretion to be inappropriate for this clinical
             study.