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

Recruiting now · Early Phase 1

Conditions studied: Skin Cancer, Cutaneous Squamous Cell Carcinoma (CSCC), Actinic Keratosis (AK), Organ Transplant Recipient

In brief

A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients This study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group. The study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine. A total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.

Key facts

Study ID

NCT07286318

Run by

Marissa Lobl

People needed

20

Starts

2026-05-01

Expected to finish

2027-06-30

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 History of solid organ transplantation At least 5 AKs in the past year or prior history of skin cancer Participants are willing to continue using SPF30 sunscreen from their own supply

You may not qualify if…

• Known allergy to niacinamide or sunscreen components Eczema or other skin conditions for which niacinamide is contraindicated

Where it is running

• UPMC Falk Dermatology — Pittsburgh, Pennsylvania, United States (enrolling)
• UPMC St Margarets Dermatology — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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