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| |  Diclofenac Gel Clears Actinic Keratoses Among Organ Transplant Recipients: Presented at AAD By Perrie Susman MIAMI BEACH, Fla -- March 12, 2010 -- Organ transplant recipients who are at high risk for skin cancer are able to clear dangerous actinic keratoses if they were treated with 3% diclofenac in 2.5% hyaluronic acid gel rather than with placebo, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). Of the 22 patients who received the gel, 41% cleared the lesions, compared with none of the 6 patients assigned a vehicle ointment. “Solid organ transplantation has been performed in over 1 million patients worldwide and increasing numbers are benefiting from transplantation,” noted Claas Ulrich, MD, Skin Cancer Center, Universitätsmedizin, Berlin, Germany, during a poster presentation on March 9. “As increasingly effective immunosuppressive therapies are developed, the overall survival times of patients receiving grafts have almost doubled within the last 20 years.” “Paralleling the increasing survival time under chronic immunosuppression, cancers are among the most frequent complications registered in organ transplant recipients. Nonmelanoma skin cancers, especially invasive squamous cell carcinomas, strongly outnumber all other malignancies in organ transplant recipients,” Dr. Ulrich reported. In the study, researchers assigned 22 of the patients who completed the study to use the active gel twice a day. They assigned 6 other patients to apply the vehicle gel twice a day as well. The patients used the gel for 16 weeks and then were followed for as long as 24 months. The active gel was successful in clearing the actinic keratoses in 2 of 5 liver transplant patients; in 4 of 13 kidney transplant patients; and in 3 of 4 heart transplant patients -- 9 of 22 of the study participants. “Side effects in most of the patients included a mild erythema and a mild to moderate swelling of the areas treated,” Dr. Ulrich said. “No graft rejections or trends for a deterioration of graft function were detected. No meaningful trends were observed in laboratory results.” Although actinic keratoses returned 5 of the 9 patients who cleared their lesions with the active gel, the researchers noted that the new lesions had a morphology that appeared to be less invasive. “This study suggests that diclofenac 3% in hyaluronic acid gel is not only an efficient and well tolerated treatment for multiple actinic keratoses in organ transplant patients but also may delay or prevent severe forms of actinic keratoses and resulting invasive squamous cell carcinoma in these high-risk patients,” Dr. Ulrich said. [Presentation title: The Efficacy and Safety of Diclofenac 3% Gel Treatment of Multiple Actinic Keratoses in Organ Transplant Patients: A Double-Blind, Randomized, Vehicle-Controlled Study. Abstract P2920]
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