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

Summary

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.

Timeline

Start

2026-05-01

Primary completion

2027-05-28

Completion

2027-06-30

Publications

• Background Zhang H, George-Washburn EA, Hashemi KB, Cho E, Walker J, Weinstock MA, Bostom A, Robinson-Bostom L, Gohh R. 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.
• Background Zalaudek I, Piana S, Moscarella E, Longo C, Zendri E, Castagnetti F, Pellacani G, Lallas A, Argenziano G. Morphologic grading and treatment of facial actinic keratosis. Clin Dermatol. 2014 Jan-Feb;32(1):80-7. doi: 10.1016/j.clindermatol.2013.05.028.
• Background Whitley MJ, Suwanpradid J, Lai C, Jiang SW, Cook JL, Zelac DE, Rudolph R, Corcoran DL, Degan S, Spasojevic I, Levinson H, Erdmann D, Reid C, Zhang JY, Robson SC, Healy E, Havran WL, MacLeod AS. ENTPD1 (CD39) Expression Inhibits UVR-Induced DNA Damage Repair through Purinergic Signaling and Is Associated with Metastasis in Human Cutaneous Squamous Cell Carcinoma. J Invest Dermatol. 2021 Oct;141(10):2509-2520. doi: 10.1016/j.jid.2021.02.753. Epub 2021 Apr 20.
• Background Torres-Moral T, Tell-Marti G, Bague J, Roses-Gibert P, Calbet-Llopart N, Mateu J, Perez-Anker J, Potrony M, Alejo B, Iglesias P, Espinosa N, Orte Cano C, Cinotti E, Del Marmol V, Fontaine M, Miyamoto M, Monnier J, Perrot JL, Rubegni P, Tognetti L, Suppa M, Demessant-Flavigny AL, Le Floc'h C, Prieto L, Malvehy J, Puig S. Evaluation of the Biological Effect of a Nicotinamide-Containing Broad-Spectrum Sunscreen on Photodamaged Skin. Dermatol Ther (Heidelb). 2024 Dec;14(12):3321-3336. doi: 10.1007/s13555-024-01298-7. Epub 2024 Nov 7.
• Background Thompson BC, Halliday GM, Damian DL. Nicotinamide enhances repair of arsenic and ultraviolet radiation-induced DNA damage in HaCaT keratinocytes and ex vivo human skin. PLoS One. 2015 Feb 6;10(2):e0117491. doi: 10.1371/journal.pone.0117491. eCollection 2015.
• Background Sivapirabu G, Yiasemides E, Halliday GM, Park J, Damian DL. Topical nicotinamide modulates cellular energy metabolism and provides broad-spectrum protection against ultraviolet radiation-induced immunosuppression in humans. Br J Dermatol. 2009 Dec;161(6):1357-64. doi: 10.1111/j.1365-2133.2009.09244.x. Epub 2009 Apr 20.
• Background Olsen EA, Abernethy ML, Kulp-Shorten C, Callen JP, Glazer SD, Huntley A, McCray M, Monroe AB, Tschen E, Wolf JE Jr. A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol. 1991 May;24(5 Pt 1):738-43. doi: 10.1016/0190-9622(91)70113-g.
• Background Park J, Halliday GM, Surjana D, Damian DL. Nicotinamide prevents ultraviolet radiation-induced cellular energy loss. Photochem Photobiol. 2010 Jul-Aug;86(4):942-8. doi: 10.1111/j.1751-1097.2010.00746.x. Epub 2010 May 13.
• Background Moloney FJ, Comber H, O'Lorcain P, O'Kelly P, Conlon PJ, Murphy GM. A population-based study of skin cancer incidence and prevalence in renal transplant recipients. Br J Dermatol. 2006 Mar;154(3):498-504. doi: 10.1111/j.1365-2133.2005.07021.x.
• Background Martinez JC, Otley CC, Stasko T, Euvrard S, Brown C, Schanbacher CF, Weaver AL; Transplant-Skin Cancer Collaborative. Defining the clinical course of metastatic skin cancer in organ transplant recipients: a multicenter collaborative study. Arch Dermatol. 2003 Mar;139(3):301-6. doi: 10.1001/archderm.139.3.301.
• Background Jansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056/NEJMoa1811850.
• Background Hwang JC, Savage KT, Pugliano-Mauro M. Nicotinamide for secondary keratinocyte carcinoma prevention in solid organ transplant recipients. Arch Dermatol Res. 2025 Jun 11;317(1):807. doi: 10.1007/s00403-025-04296-7.
• Background Gensler HL. Prevention of photoimmunosuppression and photocarcinogenesis by topical nicotinamide. Nutr Cancer. 1997;29(2):157-62. doi: 10.1080/01635589709514618.
• Background Damian DL, Patterson CR, Stapelberg M, Park J, Barnetson RS, Halliday GM. UV radiation-induced immunosuppression is greater in men and prevented by topical nicotinamide. J Invest Dermatol. 2008 Feb;128(2):447-54. doi: 10.1038/sj.jid.5701058. Epub 2007 Sep 20.
• Background Chen AC, Martin AJ, Choy B, Fernandez-Penas P, Dalziell RA, McKenzie CA, Scolyer RA, Dhillon HM, Vardy JL, Kricker A, St George G, Chinniah N, Halliday GM, Damian DL. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention. N Engl J Med. 2015 Oct 22;373(17):1618-26. doi: 10.1056/NEJMoa1506197.
• Background Allen NC, Martin AJ, Snaidr VA, Eggins R, Chong AH, Fernandez-Penas P, Gin D, Sidhu S, Paddon VL, Banney LA, Lim A, Upjohn E, Schaider H, Ganhewa AD, Nguyen J, McKenzie CA, Prakash S, McLean C, Lochhead A, Ibbetson J, Dettrick A, Landgren A, Allnutt KJ, Allison C, Davenport RB, Mumford BP, Wong B, Stagg B, Tedman A, Gribbin H, Edwards HA, De Rosa N, Stewart T, Doolan BJ, Kok Y, Simpson K, Low ZM, Kovitwanichkanont T, Scolyer RA, Dhillon HM, Vardy JL, Chadban SJ, Bowen DG, Chen AC, Damian DL. Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients. N Engl J Med. 2023 Mar 2;388(9):804-812. doi: 10.1056/NEJMoa2203086.

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Indications