To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol Mebutate (Perrigo); Ingenol Mebutate (Reference); Placebo gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 519.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare safety and efficacy of Perrigo's drug product
      compared to an FDA approved drug product in the treatment of actinic keratosis.
    

Eligibility criteria:

        Inclusion Criteria

          1. Provide written informed consent/assent

          2. Healthy male or non-pregnant females, >18 years old

          3. Subjects must have clinical diagnosis of actinic keratosis

          4. Subjects must be in general good health and free from any clinically significant
             disease that might interfere with the study evaluations in the opinion of the
             investigator

          5. Subjects must be willing to refrain from using non-approved products on the targeted
             treatment area during the study period.

          6. Subjects should be willing to refrain from using any type of bandage or dressing on
             the treatment area or apply the gel to open skin wounds, infections, or exfoliative
             dermatitis.

          7. Subjects must be willing and able to comply with the requirements of the study for the
             duration of the study period.

          8. Females of childbearing potential willing to use an acceptable form of birth control

        Exclusion

          1. Females who are pregnant, nursing, or planning a pregnancy within the study
             participation period

          2. Subjects who are immunocompromised or HIV positive or who have any immune-system
             disorders including auto-immune disease

          3. Subjects who have or had an active herpes infection within 14 days prior to the
             baseline visit

          4. Subjects who have any evidence of carcinoma or any other cancer on the face and scalp

          5. Presence of an incompletely healed wound within the treatment area or within 5cm of
             the treatment area

          6. Presence of any skin condition in the treatment area that may be made worse by
             treatment with the study medication

          7. Subjects who have used a tanning salon, tanning booth, sunbathing or have excessive
             prolonged exposure to the sun 7 days prior to Visit 1/Day 1 (baseline) or planned
             throughout the study

          8. Subjects who plan to use artificial tanners within 5cm of the selected treatment area
             throughout the study

          9. Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the
             trial.

         10. Subjects who had select cosmetic or therapeutic procedures within 2cm of the selected
             treatment area and within 14 days of Visit 1/Day 1 (baseline) or within 10cm of the
             selected treatment area planned anytime during the study.

         11. Subjects who have had or are scheduling elective surgery within 1 month before or
             after the study period

         12. Prior use within 30 days of Visit 1/ Day 1 (baseline) or planned use during the study
             of immunomodulators, immunosuppressive therapies, interferon, interferon inducers,
             systemic corticosteroids, and cytotoxic drugs

         13. Subjects undergoing treatment or received treatment within 8 weeks of Visit 1/Day 1
             (baseline) and within 2cm of the selected area or planned during anytime in the study
             of: 5-FU, imiquimod, diclofenac, photodynamic therapy used in combination with
             photosensitizing cream.

         14. Subjects who used PUVA or UVB therapy on the face or scalp within 6 months prior to
             Visit 1/Day 1 (baseline) or are planning to receive PUVA therapy, UVB therapy, or
             nonprescription UV light sources anywhere on the body during the study.

         15. Subjects who have taken systemic chemotherapy medications within the last 6 months
             prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.

         16. Subjects who have undergone resurfacing procedures within the last 6 months prior to
             Visit 1/Day 1 (baseline) or planned use anytime during the study.

         17. Subjects who have been treated within 1 month or planning to receive treatment with
             systemic retinoids, hyaluronic acid, other medicated actinic keratosis therapy, or
             topical steroids anywhere on the head during the study.

         18. Subject who have a history of hypersensitivity or allergy to any ingredient in the
             drug product.

         19. Use of medicated make-up in the treatment area or significant change in the use of
             consumer products within 30 days of Visit 1/Day 1 (baseline) and planned use or change
             throughout the study.

         20. Start or change of dose of hormonal treatment within the past 3 months (90 days) or
             planned start/change throughout the study.

         21. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements

         22. Participation in any clinical study involving an investigational product, agent, or
             device in the 30 days prior to Visit 1/Day 1 (baseline) or throughout the study

         23. Subjects who have been previously enrolled in this study

         24. Employee of the research center or private practice

         25. Subjects who in the opinion of the investigator are unlikely to be able to follow the
             restrictions of the protocol and complete the study