Study of Daily 5% Niacinamide Cream to Prevent Skin Cancer in Adults Who Had Organ Transplants

What this Trial Is About

This research aims to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. These individuals face a significantly higher risk of developing precancerous skin growths and skin cancers due to long-term use of immune-suppressing medications. The study focuses on whether daily topical niacinamide, combined with sunscreen, can reduce actinic keratoses and new keratinocyte cancers compared to sunscreen alone in this high-risk group. Participants will be randomly assigned to one of two groups one will apply topical 5% niacinamide cream once daily plus use SPF 30 sunscreen daily and every two hours when outdoors, while the control group will use sunscreen alone. The study lasts 12 months, with skin examinations at 6 and 12 months to assess changes in actinic keratosis counts and the development of new skin cancers. The safety, tolerability, and adherence to the niacinamide cream will also be evaluated. During the study, participants will undergo standardized skin mapping and clinical exams at 6 and 12 months. Researchers will collect data on treatment side effects, adherence, and patient experiences through structured surveys. Any suspicious lesions will be examined by a board-certified pathologist. The primary outcome is the change in actinic keratosis count, and secondary outcomes include the incidence of new non-melanoma skin cancers and product tolerability.

A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients