title: Diclofenac sodium 3% gel for the management of actinic keratosis: 10+ years of cumulative evidence of efficacy and safety.
abstract: BACKGROUND
  Diclofenac sodium 3% gel (Solaraze®) gained US approval for the treatment of actinic keratosis (AK) more than 10 years ago. Since the publication of the pivotal phase 3 studies, numerous clinical studies have assessed use of this therapy in a variety of body areas, special populations, and novel combinations.
  
  
  OBJECTIVE
  To provide a comprehensive update on clinical data and research on the use of diclofenac sodium 3% gel in AK.
  
  
  METHODS
  Review of the literature.
  
  
  RESULTS
  Accumulating evidence from preclinical research supports that the proposed mechanism of diclofenac sodium 3% gel may include cyclo-oxgenase 2 (COX-2) inhibition, inhibition of angiogenesis, and induction of apoptosis. A literature review identified 17 publications (beyond the 2 pivotal studies) on the use of diclofenac sodium 3% gel for AK. A phase 4 open-label study reported that 58 percent of patients achieved complete clearance of target lesions at the 30-day post-treatment assessment; among patients who were evaluable at 1-year post-treatment, sustained long-term clearance of AK lesions was observed. Active comparator studies demonstrated comparable efficacy of diclofenac sodium 3% gel with 5-fluorouracil 5% and imiquimod 5%. Publications on the efficacy of diclofenac sodium 3% gel for AK of the lip report complete clearance rates comparable to those reported for other body areas. Diclofenac sodium 3% gel has also demonstrated efficacy for clearing AK lesions in immunosuppressed populations. Sequential use of diclofenac sodium 3% gel with cryosurgery or photodynamic therapy has been investigated and may emerge as a useful approach for some patients.
  
  
  CONCLUSIONS
  Diclofenac sodium 3% gel has a unique proposed mechanism of action in AK that may involve COX-2 inhibition, inhibition of angiogenesis, and induction of apoptosis. In the past decade, numerous clinical studies have demonstrated this topical therapy to be effective and well tolerated for the treatment of AK.
authors.affiliation: Dermatoloty and Laser Center of Maui, Hawaii, USA. drgeorgemartin@aol.com
authors.forename: George M
authors.initials: GM
authors.lastname: Martin
authors.forename: Eggert
authors.initials: E
authors.lastname: Stockfleth
mesh_terms: D000279:Administration, Cutaneous; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017209:Apoptosis / Q000187:drug effects; D002986:Clinical Trials as Topic; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000473:pathology
chemical_list: D020533:Angiogenesis Inhibitors; D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D005782:Gels; D004008:Diclofenac