Article

Diclofenac sodium 3% gel in the treatment of actinic keratoses postcryosurgery.

Dermatology Associates, PA, of the Palm Beaches, Boynton Beach, FL 33437, USA.
Journal of drugs in dermatology: JDD (Impact Factor: 1.32). 08/2008; 7(7):669-73.
Source: PubMed

ABSTRACT Actinic keratoses are increasingly common skin lesions that are evaluated and treated by dermatologists on a daily basis. It is estimated that more than 90% of actinic keratoses in the US are treated by destructive therapies, such as cryosurgery. The purpose of this study was to evaluate the efficacy of sequential therapy of cryosurgery followed by diclofenac sodium 3% gel.
This prospective, double-arm, multicenter, open-label, phase 4 study was performed at 82 community dermatology centers in the US. A total of 714 subjects who had a clinical diagnosis of actinic keratosis with between 5 and 15 lesions contained in a target area such as the forehead, scalp, and hands were enrolled in the study. These subjects were randomized into 2 arms of the study: cryosurgery alone and cryosurgery followed by diclofenac sodium 3% gel for a period of 90 days. Lesion counts were assessed at baseline, and 45, 75, 105, and 135 days after cryosurgery.
Of the 521 patients enrolled in the study who successfully completed all of the visits concluding on day 135, 277 were in the cryosurgery alone arm and 244 were in the cryosurgery followed by diclofenac sodium 3% gel arm. At the conclusion of the study, 46% of the subjects in the cryosurgery followed by the use of diclofenac sodium 3% gel arm achieved 100% cumulative (target plus new lesions) lesion clearance compared to 21% in the cryosurgery alone arm (P < .0001). One hundred percent target lesion clearance was achieved in 64% of the subjects in the active arm compared to 32% in the cryosurgery alone arm (P < .0001).
With the increased prevalence of actinic keratoses, it is important to consider and evaluate emerging therapeutic options. The sequential treatment with cryosurgery followed by diclofenac sodium 3% gel for 90 days is well tolerated and can provide a therapeutic modality that may provide patients with actinic keratoses a more successful outcome than monotherapy with cryosurgery by effectively treating clinical and subclinical lesions.

0 Followers
 · 
127 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Actinic keratosis is a common dermatologic condition that may regress, remain stable, or progress to squamous cell carcinoma. Some question whether all actinic keratoses should be routinely treated, whereas others contend that the unpredictable natural history of this disease necessitates treatment to prevent malignant transformation. Available treatments include photodynamic therapy, cryotherapy, 5-fluorouracil, imiquimod, and diclofenac. Each of these options has its advantages and disadvantages, although they all have a place in the management of actinic keratosis. An overview of these treatment modalities is presented, as are the controversies surrounding the treatment of actinic keratosis.
    Clinics in dermatology 11/2013; 31(6):712-7. DOI:10.1016/j.clindermatol.2013.05.007 · 1.93 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Actinic keratosis is a common disease in older, fair-skinned people, and is a consequence of cumulative ultraviolet exposure. It is part of a disease continuum in photodamaged skin that may lead to invasive squamous cell carcinoma. Treatment options frequently used include cryosurgery and topical pharmacologic agents, which are examples of lesion-directed and field-directed strategies. Ingenol mebutate gel was recently approved by the US Food and Drug Administration for topical treatment of actinic keratosis. While the mechanism of action of ingenol mebutate is not fully understood, in vitro and in vivo studies using tumor models indicate it has multiple mechanisms. Ingenol mebutate directly induces cell death by mitochondrial swelling and loss of cell membrane integrity preferentially in transformed keratinocytes. It promotes an inflammatory response characterized by infiltration of neutrophils and other immunocompetent cells that kills remaining tumor cells. The ability of ingenol mebutate to eliminate mutant p53 patches in ultraviolet-irradiated mouse skin suggests that it may have the potential to treat chronically ultraviolet-damaged skin. In human studies, ingenol mebutate achieved high clearance of actinic keratosis on the head and body after 2-3 consecutive daily treatments when measured by complete or partial clearance of lesions. Localized inflammatory skin responses were generally mild to moderate and resolved in less than a month.
    Clinical, Cosmetic and Investigational Dermatology 08/2012; 5:111-22. DOI:10.2147/CCID.S28905
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Actinic keratoses are areas of intraepithelial neoplasia for which treatment is necessary. Because they arise in areas of sun damage, it is desirable to treat the entire damaged field to not only treat visible lesions, but also subclinical, emerging malignancies, ie, "field therapy", 5-fluorouracil, imiquimod, and diclofenac are all treatment options, and are discussed and compared.
    Therapeutics and Clinical Risk Management 06/2011; 7:207-11. DOI:10.2147/TCRM.S12498 · 1.34 Impact Factor