A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

Inclusion criteria

• . Signed informed consent form, which meets all criteria of current FDA and HIPAA regulations.
• . Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
• . Diagnosis of AK with ≥ 5 and \< 10 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25cm2 treatment area.
• . Women either must be 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:
• . Have been using systemic birth control, IUD, or Norplant for at least 28 days prior to the start of treatment period of the study, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study gel administration.
• . Had a normal menstrual cycle for the month prior to the start of treatment.
• . Have a negative urine pregnancy test result upon entry into the study.
• . Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.

Exclusion criteria