Major Finding: Complete clearance of actinic keratoses was achieved in 41% of patients treated wtih diclofenac 3% gel, compared to 0% in the control group.
Data Source: The 32 organ transplant patients were randomized 3-to-1 to diclofenac or a vehicle control.
Disclosures: Dr. Stockfleth disclosed serving as a consultant to Graceway, Almirall, Spirig, Itendis, Meda, Abbott, and Leo.
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 congress.
Based upon an earlier favorable but uncontrolled six-patient series (Br. 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 makes them highly vulnerable to multiple invasive SCCs, he said. As graft survival has improved over time, the high incidence of aggressive cutaneous malignancies in transplant recipients has grown into 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. The risk of aggressive skin cancers in these patients is far higher than that of other malignancies, said Dr. Stockfleth, 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-cm
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 to 0 of 6 controls.
Side effects were limited to mild erythema and mild to moderate swelling of treated areas.
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.
Therapy with 3% diclofenac acid also prevented invasive squamous cell carcinomas.
Source DR. STOCKFLETH