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Diclofenac sodium 3% gel for the management of actinic keratosis: 10+ years of cumulative evidence of efficacy and safety.
MedLine Citation:
PMID:  22527428     Owner:  NLM     Status:  In-Data-Review    
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. J Drugs Dermatol. 2012;11(5):600-608.
George M Martin; Eggert Stockfleth
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of drugs in dermatology : JDD     Volume:  11     ISSN:  1545-9616     ISO Abbreviation:  J Drugs Dermatol     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101160020     Medline TA:  J Drugs Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  600-8     Citation Subset:  IM    
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