Oral Nicotinamide for Actinic Keratosis Prevention in Kidney Transplant Recipients: A Pilot Double-Blind, Randomized, Placebo-Controlled Trial.
Helen Zhang, Elisabeth A George-Washburn, Kimberly B Hashemi...
https://pubmed.ncbi.nlm.nih.gov/37838527Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID07286318
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients
Led by Marissa Lobl · Updated on 2026-06-05
20
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of solid organ transplantation
- At least 5 actinic keratoses in the past year or prior history of non-melanoma skin cancer
- Willingness to continue using SPF 30 sunscreen from own supply
You will not qualify if you...
- Known allergy to niacinamide or sunscreen components
- Eczema or other skin conditions for which niacinamide use is contraindicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants apply topical 5% niacinamide cream daily to sun-exposed areas and use SPF 30 sunscreen daily and every 2 hours when outdoors, or use sunscreen alone as per their assigned group, for skin cancer prevention.
Visits at baseline, 6 months, and 12 months for assessments
Follow-up
Duration - Up to 1 month after treatment completion
Participants are monitored for new skin lesions and side effects during follow-up visits after the treatment period.
May include final study visit at 12 months
Trial Site Locations
Total: 2 locations
1
UPMC Falk Dermatology
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
UPMC St Margarets Dermatology
Pittsburgh, Pennsylvania, United States, 15238
Actively Recruiting
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Research Team
M
Marissa Lobl, Resident Physician, Principal Investigator, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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