To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

Inclusion criteria

• Provide written informed consent/assent
• Healthy male or non-pregnant females, >18 years old
• Subjects must have clinical diagnosis of actinic keratosis
• 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
• Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
• 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.
• Subjects must be willing and able to comply with the requirements of the study for the duration of the study period.
• Females of childbearing potential willing to use an acceptable form of birth control

Exclusion

• Females who are pregnant, nursing, or planning a pregnancy within the study participation period
• Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
• Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
• Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
• Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area
• Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication
• 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
• Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study
• Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial.
• 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.
• Subjects who have had or are scheduling elective surgery within 1 month before or after the study period
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• Subject who have a history of hypersensitivity or allergy to any ingredient in the drug product.
• 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.
• Start or change of dose of hormonal treatment within the past 3 months (90 days) or planned start/change throughout the study.
• Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
• 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
• Subjects who have been previously enrolled in this study
• Employee of the research center or private practice
• Subjects who in the opinion of the investigator are unlikely to be able to follow the restrictions of the protocol and complete the study