A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Diclofenac sodium; Placebo
Intervention description: Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.; Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3%
      (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)
      in the treatment of the actinic keratosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent form, which meets all criteria of current FDA and HIPAA
             regulations.

          2. Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.

          3. 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.

          4. 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:

               1. 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.

               2. Had a normal menstrual cycle for the month prior to the start of treatment.

               3. Have a negative urine pregnancy test result upon entry into the study.

               4. 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.

          5. Free from any systemic or dermatologic disorder that, in the opinion of the
             Investigator, will interfere with the study results or increase the risk of AEs.

          6. Any skin type or race, providing the skin pigmentation will allow discernment of
             erythema.

          7. Willingness and capability to cooperate to the extent and degree required by the
             protocol.

        Exclusion Criteria:

          1. Active gastrointestinal ulceration or bleeding.

          2. Current or history of severe renal or hepatic impairment.

          3. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema,
             psoriasis, rosacea, sunburn or other possible skin conditions on the face or bald
             scalp that in the investigator's opinion would interfere with the study assessments.

          4. Use within six months prior to randomization of oral isotretinoin.

          5. Use within six months prior to randomization on the face or bald scalp of 1) chemical
             peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A)
             therapy, or 5) UVB therapy

          6. Use within one month prior to randomization on the face or bald scalp of 1)
             cryodestruction or chemodestruction, 2)curettage, 3) photodynamic therapy, 4) surgical
             excision, 5)topical 5-fluorouracil, 6) topical corticosteroids, 7) topical diclofenac,
             8) topical Imiquimod, 9) topical retinoids, or 10) other treatments for actinic
             keratosis including glycolic acids or over-the-counter products containing retinol,
             alpha or beta hydroxy acids.

          7. Use within one month prior to randomization of 1)immunomodulators or immunosuppressive
             therapies, 2)interferon, 3) systemic corticosteroids or 4) cytotoxic drugs. (The
             occasional use of ophthalmic, nasal or inhaled steroids is acceptable and not reason
             for exclusion)

          8. Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl
             ether 359, hyaluronate sodium or any excipients in the test or reference gels.

          9. Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior
             to randomization.

         10. Any condition, medical, psychological, or social, that, in the Investigator's opinion,
             would interfere with participation in the study.

         11. Women who are pregnant, planning pregnancy or lactating.

         12. Participation in any investigational drug study within 30 days of randomization or
             previous participation in this study.

         13. Employees of the research center or Investigator.

         14. Family members of employees of the research center or Investigator.