Topical Niacinamide for Skin Cancer Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a cream with 5% niacinamide (a form of vitamin B3) can help prevent skin cancer in individuals who have had an organ transplant. These individuals face a higher risk of skin cancer due to medications that weaken their immune systems. The study will compare the effectiveness of niacinamide cream plus sunscreen against sunscreen alone in reducing precancerous skin changes and new skin cancers. Participants should be organ transplant recipients with a history of multiple precancerous skin growths or skin cancer. The trial will also assess how well participants tolerate the cream and whether they can easily incorporate it into their daily routine. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves organ transplant recipients who typically take immune-suppressing drugs, it seems likely that you can continue your current medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that nicotinamide, a type of vitamin B3, may help lower the risk of skin cancer. In one study, people taking nicotinamide had fewer skin cancers than those who did not. Another study found that nicotinamide pills were safe and helped reduce new cases of non-melanoma skin cancers and rough, precancerous skin patches in people at high risk.
This trial tests a 5% niacinamide cream applied to the skin. Previous studies suggest that nicotinamide is usually safe, with few serious side effects. While this trial examines the cream's safety, past research on nicotinamide pills suggests it might be safe for skin use. Researchers will closely monitor participants for any side effects.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for skin cancer prevention, which primarily includes using broad-spectrum sunscreens to block harmful UV rays, the treatment with niacinamide offers a novel approach. Niacinamide, a form of vitamin B3, is applied topically and works by enhancing the skin's natural repair mechanisms, potentially preventing DNA damage from sun exposure. Researchers are excited about niacinamide because it not only protects but also repairs, offering a dual benefit that current sunscreen options don't provide. This could mean more comprehensive skin protection, reducing the risk of skin cancer more effectively.
What evidence suggests that topical niacinamide might be an effective treatment for skin cancer prevention in organ transplant recipients?
Research has shown that niacinamide, a type of vitamin B3, might help protect against skin cancer. In earlier studies, participants who took niacinamide pills developed fewer new skin cancers and precancerous spots. This suggests that niacinamide can aid skin repair and strengthen its defense against sun damage. The current trial will compare two treatment arms: one where participants apply a cream with niacinamide in addition to using sunscreen, and another where participants use sunscreen only. Although limited information exists on the cream's effectiveness, the positive results from the pills suggest it might help prevent skin cancers, especially in high-risk individuals, such as those who have had organ transplants.
Are You a Good Fit for This Trial?
This trial is for adult organ transplant recipients who have had multiple actinic keratoses and at least one non-melanoma skin cancer. They should be willing to apply a topical cream daily and use sunscreen.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily topical 5% niacinamide plus sunscreen or sunscreen alone for skin cancer prevention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Niacinamide
Trial Overview
The study tests if using a 5% niacinamide cream every day can reduce precancerous skin growths over 6 to 12 months, compared to just sunscreen. It also checks if it prevents new skin cancers in high-risk patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In addition to using broad spectrum SPF 30 daily sunscreens, participants will apply topical 5% niacinamide daily to any sun exposed areas.
The participants will not be assigned to any intervention. They will use broad spectrum SPF 30 daily sunscreen as instructed regardless of whether or not they are enrolled in the study.
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Who Is Running the Clinical Trial?
Marissa Lobl
Lead Sponsor
Citations
Effect of Nicotinamide in Skin Cancer and Actinic Keratoses ...
Nicotinamide was associated with a significant reduction in skin cancers compared to control (rate ratio 0.50 (95% CI, 0.29-0.85; I 2 = 64%; 552 patients; 5 ...
A Randomized Controlled Trial of Topical 5% Niacinamide ...
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 ...
A Phase 3 Randomized Trial of Nicotinamide for Skin ...
Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients.
Nicotinamide: An Update and Review of Safety & ...
Thus, it appears that oral nicotinamide is an effective chemoprotective agent for most patients with varying degrees of immunological status and ...
5.
news.vumc.org
news.vumc.org/2025/09/17/study-reveals-efficacy-of-nicotinamide-for-skin-cancer-prevention/Study reveals efficacy of nicotinamide for skin cancer prevention
Overall, there was a 14% reduction in skin cancer risk. When nicotinamide was taken after a first skin cancer, the risk reduction rose to 54%, ...
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