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; Eunyoung Cho; Joanna Walker; Martin A Weinstock; Andrew Bostom; Leslie Robinson-Bostom; Reginald Gohh

doi:10.1016/j.transproceed.2023.06.016

Oral Nicotinamide for Actinic Keratosis Prevention in Kidney Transplant Recipients: A Pilot Double-Blind, Randomized, Placebo-Controlled Trial

Transplant Proc. 2023 Nov;55(9):2079-2084. doi: 10.1016/j.transproceed.2023.06.016. Epub 2023 Oct 12.

Authors

Helen Zhang¹, Elisabeth A George-Washburn², Kimberly B Hashemi³, Eunyoung Cho⁴, Joanna Walker⁵, Martin A Weinstock⁶, Andrew Bostom⁷, Leslie Robinson-Bostom⁶, Reginald Gohh⁸

Affiliations

¹ The Warren Alpert Medical School of Brown University, Providence, RI.
² Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.
³ Department of Dermatology, Medical University of South Carolina, Charleston, SC.
⁴ Department of Epidemiology, School of Public Health, Brown University, Providence, RI; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
⁵ Department of Dermatology, The Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI; Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
⁶ Department of Dermatology, The Warren Alpert Medical School of Brown University, Rhode Island Hospital, Providence, RI.
⁷ Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
⁸ Division of Organ Transplantation, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: rgohh@lifespan.org.

PMID: 37838527
DOI: 10.1016/j.transproceed.2023.06.016

Abstract

Background: Oral nicotinamide (NAM) has shown promise in preventing actinic keratoses (AKs) in trials based outside of the United States. We assessed the efficacy of oral NAM supplementation in kidney transplant recipients with a history of keratinocyte carcinoma.

Material and methods: Patients enrolled in a 2-week run-in phase, during which NAM 1000 mg was taken twice daily. After a washout period, patients who tolerated the run-in phase were randomized to NAM 500 mg twice daily or placebo. At baseline, 4, 8, and 12 months, dermatologists conducted full-body skin exams to document area-specific AKs. Routine lab work was collected to ensure the stability of renal allograft function.

Results: The dosage was reduced from 1000 to 500 mg due to gastrointestinal symptoms in the run-in phase. Patients were randomized to NAM (n = 10) or placebo (n = 11). At 12 months, mean AK count was 30.8 (95% CI -11.7-73.4) for NAM and 26.6 (95% CI 10.8-42.5) for placebo. The difference in percent AK count change at 12 months compared with baseline was 259.8% (95% CI -385.9 to 905.5) for NAM and 72.4% (95% CI -118.6 to 263.5) for placebo. The between-group difference in percent AK change was not significant (P = .38). There was no attrition in the placebo group and 40% attrition in the NAM arm.

Discussion: Nicotinamide did not decrease AK development among kidney transplant recipients. Limitations include drug tolerability, small sample size, and single-center trial nature.

Publication types

Randomized Controlled Trial

MeSH terms

Double-Blind Method
Humans
Keratosis, Actinic* / diagnosis
Keratosis, Actinic* / drug therapy
Keratosis, Actinic* / pathology
Kidney Transplantation* / adverse effects
Niacinamide / adverse effects
Skin / pathology
Treatment Outcome

Substances

Niacinamide