GOTHENBURG, SWEDEN – Topical diclofenac 3% gel proved effective for the treatment of actinic keratoses in organ transplant recipients, according to the results of a new study.
Sixteen weeks of twice-daily therapy with 3% diclofenac in 2.5% hyaluronic acid (Solaraze) not only proved effective and well tolerated for actinic keratoses (AK) clearance in a randomized, placebo-controlled trial, it also prevented invasive squamous cell carcinomas (SCCs) in organ transplant recipients, Dr. Eggert Stockfleth reported at the annual congress of the European Academy of Dermatology and Venereology.
Dr. Eggert Stockfleth
Based upon an earlier favorable but uncontrolled six-patient series (B. J. Dermatol. 2007;156 Suppl. 3:40-2), Dr. Stockfleth and his coworkers conducted a follow-up randomized trial of topical diclofenace 3% gel in 32 organ transplant recipients.
Organ transplant recipients' immunocompromised status renders them highly vulnerable to multiple invasive SCCs, he said. As graft survival has improved over the years, the high incidence of aggressive cutaneous malignancies in organ transplant recipients has come to the fore as a major concern.
In Australia and New Zealand, cancer is now the No. 1 cause of death in organ transplant recipients, not heart disease, graft rejection, or infection. And the risk of aggressive skin cancers in these patients is far higher than the risk of other malignancies, according to Dr. Stockfleth of the director of the skin cancer center at Charité University Hospital, Berlin.
The 32 study participants were randomized 3-to-1 to diclofenac or a vehicle control. Study eligibility required a stable graft during the previous 12 months plus three or more AKs in a 50-cm2 area on the face, hands, or scalp.
Twenty-eight patients (88%) completed the 16-week, twice-daily treatment phase and presented for final evaluation 4 weeks later. Complete clearance of AKs was achieved in 9 of 22 (41%) of the diclofenac group, compared with 0 of 6 controls.
Side effects were limited to mild erythema and mild-to-moderate swelling of treated areas. No laboratory abnormalities or effects on graft function were noted.
With further follow-up, 55% of the patients who had previously cleared developed new AKs in the treated areas an average of 9.3 months after treatment ended. None of these patients developed invasive SCC in the study area within 24 months of follow-up, suggesting that topical diclofenac gel may also prevent invasive SCCs in this high-risk population.
Other treatments that have demonstrated efficacy for treatment of AKs and/or prevention of nonmelanoma skin cancer in high-risk organ transplant recipients include regular use of a sunscreen, imiquimod 5% cream, topical 5-fluorouracil, and photodynamic therapy.
Dr. Stockfleth disclosed serving as a consultant to Graceway, Almirall, Spirig, Intendis, Meda, Abbott, and LEO.