No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
20 (estimated)
Sponsor
Marissa Lobl · Other
Who this trial is looking for
This trial is looking for adult organ transplant recipients who want to help prevent skin cancer. Participants will use a niacinamide cream daily along with sunscreen for 12 months.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have received an organ transplant
I have had at least 5 actinic keratoses in the past year
I have a history of skin cancer
I am willing to use SPF30 sunscreen from my own supply
You may not be able to join if
I have a known allergy to niacinamide or sunscreen
I have eczema or other skin conditions where niacinamide can't be used
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-ter…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Known allergy to niacinamide or sunscreen components Eczema or ot…
Inclusion Criteria:
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
Exclusion Criteria:
Known allergy to niacinamide or sunscreen components Eczema or other skin conditions for which niacinamide is contraindicated
Contacts
Marissa Lobl, Resident Physician, Principal Investigator, MD, PhD
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