Berlin Joshua M, Rigel Darrell S
Dermatology Associates, PA, of the Palm Beaches, Boynton Beach, FL 33437, USA.
J Drugs Dermatol. 2008 Jul;7(7):669-73.
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.
光化性角化病是日益常见的皮肤病变，皮肤科医生每天都要对其进行评估和治疗。据估计，美国超过90%的光化性角化病采用冷冻手术等破坏性疗法进行治疗。本研究的目的是评估冷冻手术序贯3%双氯芬酸钠凝胶治疗的疗效。
这项前瞻性、双臂、多中心、开放标签的4期研究在美国的82个社区皮肤科中心进行。共有714名临床诊断为光化性角化病的受试者入组，其目标区域（如前额、头皮和手部）有5至15个病变。这些受试者被随机分为研究的两组：单纯冷冻手术组和冷冻手术后使用3%双氯芬酸钠凝胶组，为期90天。在基线时以及冷冻手术后45、75、105和135天评估病变数量。
在成功完成所有至第135天访视的521名入组患者中，277名在单纯冷冻手术组，244名在冷冻手术后使用3%双氯芬酸钠凝胶组。在研究结束时，冷冻手术后使用3%双氯芬酸钠凝胶组46%的受试者实现了100%的累积（目标病变加新病变）病变清除，而单纯冷冻手术组为21%（P < .0001）。活性药物组64%的受试者实现了100%的目标病变清除，而单纯冷冻手术组为32%（P < .0001）。
随着光化性角化病患病率的增加，考虑和评估新出现的治疗选择很重要。冷冻手术序贯3%双氯芬酸钠凝胶治疗90天耐受性良好，并且可以提供一种治疗方式，通过有效治疗临床和亚临床病变，为患有光化性角化病的患者提供比单纯冷冻手术更成功的治疗结果。
