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A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention
Abstract
BACKGROUND: Nonmelanoma skin cancers, such as basal-cell carcinoma and squamous-cell carcinoma, are common cancers that are caused principally by ultraviolet (UV) radiation. Nicotinamide (vitamin B3) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses. METHODS: In this phase 3, double-blind, randomized, controlled trial, we randomly assigned, in a 1:1 ratio, 386 participants who had had at least two nonmelanoma skin cancers in the previous 5 years to receive 500 mg of nicotinamide twice daily or placebo for 12 months. Participants were evaluated by dermatologists at 3-month intervals for 18 months. The primary end point was the number of new nonmelanoma skin cancers (i.e., basal-cell carcinomas plus squamous-cell carcinomas) during the 12-month intervention period. Secondary end points included the number of new squamous-cell carcinomas and basal-cell carcinomas and the number of actinic keratoses during the 12-month intervention period, the number of nonmelanoma skin cancers in the 6-month postintervention period, and the safety of nicotinamide. RESULTS: At 12 months, the rate of new nonmelanoma skin cancers was lower by 23% (95% confidence interval [CI], 4 to 38) in the nicotinamide group than in the placebo group (P=0.02). Similar differences were found between the nicotinamide group and the placebo group with respect to new basal-cell carcinomas (20% [95% CI, -6 to 39] lower rate with nicotinamide, P=0.12) and new squamous-cell carcinomas (30% [95% CI, 0 to 51] lower rate, P=0.05). The number of actinic keratoses was 11% lower in the nicotinamide group than in the placebo group at 3 months (P=0.01), 14% lower at 6 months (P<0.001), 20% lower at 9 months (P<0.001), and 13% lower at 12 months (P=0.001). No noteworthy between-group differences were found with respect to the number or types of adverse events during the 12-month intervention period, and there was no evidence of benefit after nicotinamide was discontinued. CONCLUSIONS: Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients. (Funded by the National Health and Medical Research Council; ONTRAC Australian New Zealand Clinical Trials Registry number, ACTRN12612000625875.).
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“Clinical trials have demonstrated the efficacy of NAD + precursors in the chemoprevention of non-melanoma skin cancer 126 , in reversing insulin resistance in prediabetic women 127 , and in reducing neuroinflammation in patients with Parkinson 's disease 128 .”
From Hallmarks of aging: An expanding universe (2023) · cites this paper as [126]
In the citing paper
“| | Human | NAM in patients with 2 non- melanoma skin cancers in the preceding 5 years (Phase 3 trial) | Reduced rates of new nonmelanoma skin cancers and keratosis | 126 |”
From Hallmarks of aging: An expanding universe (2023) · cites this paper as [126]
In the citing paper
“the clinical data showing NAM is relatively safe (1,000–2,000 mg/day) and is readily absorbed from the gastrointestinal tract with peak serum concentrations in 1 h after oral ingestion”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
In the citing paper
“in some cases NAD+/NADH and its metabolites can inhibit cancer growth and metastasis”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
In the citing paper
“A phase-III randomized large clinical trial reported that oral NAM was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratosis in high-risk patients”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
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“Based on these observations and other reports of photoprotection [18, 19, 21 – 23], we wanted to determine whether combining nicotinamide with compounds demonstrating different mechanisms of action would enhance its photoprotection.”
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“A phase III clinical trial with immunocompetent patients demonstrated that nicotinamide reduced the number of cSCC lesions by approximately 30% in comparison to the placebo [98].”
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“Nicotinamide shows promising data as an alternative option for chemoprevention, although long-term studies are needed to investigate the durability of response.(22,24,30) The current data for nicotinamide in immunocompromised populations is generally lacking, making it difficult to generalize the efficacy to these hig…”
BackgroundIs the first‐line systemic chemoprevention of nonmelanoma skin cancer nicotinamide or acitretin?
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“4,16 23 Other preventive treatments in XP patients include: systemic retinoids such as isotretinoin, 24 oral nicotinamide (NAM), 16,25 and oral antioxidants.”
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“Finally, our trial and Chen’s on nicotinamide[13] suggest that late-stage events play an essential role in skin cancer pathogenesis.”
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Mounessa, J. S., Qin, R., Dunnick, C. A., & Dellavalle, R. P. (2016) · American Journal of Clinical Dermatology · doi:10.1007/s40257-016-0208-2 · Cited by 8
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“Furthermore, the therapeutic benefits of NAM has also been observed in the treatment of actinic keratosis(11) and melanoma.(12,13) NAM primarily exerts its effect on cellular energy metabolism through its precursor nicotinamide adenine dinucleotide (NAD), a component of the electron transport chain machinery in the mi…”
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“…between the two groups) were diagnosed during the 12-month intervention period and a non-significant trend toward the development of more squamous-cell carcinomas in the nicotinamide group than in the placebo group in the 6-month postintervention period was observed (Chen et al., 2015).”
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“sun protection, sunscreen use, patient compliance, skin cancer prevention remains poor for Australian adults, even among those with multiple previous skin cancers (Chen et al., 2015).”
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“In 2015, a phase 3 randomized clinical trial successfully showed that oral nicotinamide (an amide form of vitamin B3) was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratosis in high-risk patients.(2) Further studies are needed to determine the efficacy of this treatment in pa…”
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“%) had NMSC.3 In our patient, the onset of SCC/AK occurred 5 years after onset of cGVHD and 3 years after initiation of voriconazole.”
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Investigative Landscape in Advanced Non-Melanoma Skin Cancers
Reddy, P., Yao, M., & Patel, M. (2021) · Current Treatment Options in Oncology · doi:10.1007/s11864-021-00853-0 · Cited by 5
Nicotinamide for Keratinocyte Carcinoma Chemoprevention: A Nationwide Survey of Mohs Surgeons
Lim, R. K., & Weinstock, M. A. (2021) · Dermatologic Surgery · doi:10.1097/dss.0000000000003197 · Cited by 5
Dietary B vitamins and glioma: A case–control study based on Chinese population
Zhang, W., Jiang, J., Kang, X., Wang, C., Chen, F., Zhang, B., Li, S., Huang, S., & Li, W. (2023) · Frontiers in Nutrition · doi:10.3389/fnut.2023.1122540 · Cited by 5
“found that niacinamide, a nicotinic acid derivative, can reduce the incidence of non-melanoma skin cancer by 23% (17).”
BackgroundGollins, C. E., Shah, A., Sinha, K., Khan, S., Paul, N., Meeajun, B., Abbott, R. A., Blasdale, C., Cooper, H. L., Harwood, C. A., et al. (2020) · British Journal of Dermatology · doi:10.1111/bjd.18982 · Cited by 5
Nutrition and nonmelanoma skin cancers
Stoj, V. J., Shahriari, N., Shao, K., & Feng, H. (2021) · Clinics in Dermatology · doi:10.1016/j.clindermatol.2021.10.011 · Cited by 5
Taylor, J. H., & Rosen, C. F. (2020) · Current Dermatology Reports · doi:10.1007/s13671-020-00306-1 · Cited by 7
“The chemopreventive benefits were not evident once the nicotinamide was stopped, suggesting that continued use is necessary to maintain the effect [28].”
BackgroundChronic lymphocytic leukaemia and secondary skin malignancies
Kyle, G. (2017) · British Journal of Nursing · doi:10.12968/bjon.2017.26.18.1026 · Cited by 5
Mohamad, A. F., Philipsen, P. A., Lerche, C. M., Douki, T., Laursen, F. S. W., Granborg, J. R., Bjerring, P., Hædersdal, M., & Wiegell, S. R. (2025) · Photochemical & Photobiological Sciences · doi:10.1007/s43630-025-00807-7 · Cited by 4
Razi, S., Khan, S., Truong, T. M., Zia, S., Khan, F. F., Uddin, K. M., & Rao, B. K. (2023) · Dermato · doi:10.3390/dermato3020013 · Cited by 4
“Capecitabine, an oral precursor of 5-FU, has shown a 50% reduction in cSCC in 13 of 18 OTR patients, but 56% of patients ended up discontinuing capecitabine for various reasons [120].”
BackgroundWang, S., Gao, S., Lin, S., Fang, X., Zhang, H., Qiu, M., Zheng, K., Ji, Y., Xiao, B., & Zhang, X. (2024) · BMC Neurology · doi:10.1186/s12883-024-03924-5 · Cited by 5
“Moreover, three clinical trials have demonstrated that oral nicotinamide substantially reduces the incidence rate of actinic keratosis and non-melanoma skin cancer [9].”
BackgroundDousset, L., Chambers, D. C., Webster, A. C., Isbel, N. M., Campbell, S. B., Duarte, C., Collins, L. G., Damian, D. L., Tseng, A., Karlsen, E., et al. (2024) · Trials · doi:10.1186/s13063-024-08619-3 · Cited by 4
“More recently, nicotinamide has been proposed as a chemopreventive measure for KCs, but not in SOTRs [19-20].”
Self-citationSkillen, L. A., & Corry, A. J. (2018) · Clinical and Experimental Dermatology · doi:10.1111/ced.13822 · Cited by 4
Cutaneous Malignancies of the Head and Neck
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Ferreira, E. R., Miola, A. C., Lima, T. R. R., Schmitt, J. V., Abbade, L. P. F., & Miot, H. A. (2021) · Anais Brasileiros de Dermatologia · doi:10.1016/j.abd.2020.09.012 · Cited by 4
Eruptive basal cell carcinoma and lenalidomide: rising awareness among dermatologists
Pagliarello, C., Girardelli, C. R., & Stanganelli, I. (2022) · Dermatology Reports · doi:10.4081/dr.2022.9534 · Cited by 4
Kahn, B., Borrelli, M. R., & Libby, T. J. (2022) · Journal of Drugs in Dermatology · doi:10.36849/jdd.6870 · Cited by 4
Functional Foods in Dermatology
Strouphauer, E., Parke, M. A., Perez-Sanchez, A. C., Tantry, E. K., & Katta, R. (2023) · Dermatology Practical & Conceptual · doi:10.5826/dpc.1304a256 · Cited by 6
“A large, multicenter, phase III trial demonstrated the benefit of oral nicotinamide in reducing the rates of actinic kera-toses and non-melanoma skin cancer in a high-risk patient group [55].”
BackgroundFR - Nuevas indicaciones de nicotinamida en dermatología
Escudero‐Góngora, M. M., & Fernández‐Peñas, P. (2016) · Actas Dermo-Sifiliográficas · doi:10.1016/j.ad.2016.05.015 · Cited by 4
Self-citationNicotinamide: New Indications in Dermatology
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“This reduction is more evident in patients with greater sun damage and who had previously presented a greater number of NMSCs.(1) The effect disappeared 6 months after stopping nicotinamide.”
InfluentialSelf-citationNicotinamide in the prevention of breast cancer recurrences?
Dell’Omo, G., & Ciana, P. (2019) · Oncotarget · doi:10.18632/oncotarget.27173 · Cited by 4
Nicotinamide for high-risk skin cancer patients: An update
Duncan, K. O., Stock, E. O., Damian, D. L., & Miller, S. J. (2024) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2024.08.035 · Cited by 4
Self-citationAvendaño, C., & Menéndez, J. C. (2023) · Medicinal Chemistry of Anticancer Drugs · doi:10.1016/b978-0-12-818549-0.00019-4 · Cited by 4
Role of Nicotinamide in the Pathogenesis of Actinic Keratosis: Implications for NAD+/SIRT1 Pathway
Belardi, R., Pacifici, F., Cosio, T., Lambiase, S., Shumak, R. G., Artosi, F., Rivieccio, A., Cavalloro, D., Dellambra, E., Bianchi, L., et al. (2024) · Biomolecules · doi:10.3390/biom14121512 · Cited by 3
“…al. [16] demonstrated NAM’s role in enhancing DNA repair in UV-irradiated keratinocytes, thereby reducing AK formation and subsequent SCCs. Additionally, NAM’s increase in NAD + levels, essential for the activity of enzymes like sirtuins, maintains genomic stability and reduces inflammation [16].”
InfluentialGrape constituents for protection against photodamage to skin
Kwon, Y., Shafi, R., Oak, A. S. W., Athar, M., Slominski, A. T., & Elmets, C. A. (2025) · Photochemistry and Photobiology · doi:10.1111/php.14110 · Cited by 4
Nicotinamide for Skin Cancer Chemoprevention
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Clinical practice guidelines for the management of basal cell carcinoma in Gorlin syndrome
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Management of cutaneous squamous cell carcinoma: A literature review and update
Trager, M. H., Gordon, E. R., Breneman, A., LeWitt, T. M., Cahn, B. A., Alam, M., Billingsley, E. M., Connolly, K. L., Nehal, K. S., Vidimos, A. T., et al. (2025) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2025.11.043 · Cited by 5
Vitamins and oral mucosal diseases: From bench to the bedside
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“Nicotinamide has been shown to reduce the development of actinic keratoses and associated cancers in the general population but had not until recently been well studied in the organ transplant population [112,113].”
Background
Metadata
- Authors
- Chen, A. C., Martin, A. J., Choy, B., Fernández-Peñas, P., Dalziell, R. A., McKenzie, C. A., Scolyer, R. A., Dhillon, H. M., Vardy, J. L., Kricker, A., St. George, G., Chinniah, N., Halliday, G. M., & Damian, D. L.
- Affiliations
- The University of Sydney (AU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-10-22
- Volume
- 373
- Issue
- 17
- Pages
- 1618-1626
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1852538637
- Cited by
- 648
- References
- 38
- Citations by year
- 2026: 53 · 2025: 66 · 2024: 59 · 2023: 74 · 2022: 61 · 2021: 75 · 2020: 55 · 2019: 57 · 2018: 49 · 2017: 51 · 2016: 38 · 2015: 4
- FWCI
- 37.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Keywords
- nicotinamide, nicotinic acid, skin cancer chemoprevention, non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, actinic keratosis, ultraviolet radiation, UV-induced DNA damage, NADPH oxidase, NADPH oxidase inhibitors, adverse events, drug safety, recurrence prevention, long-term follow-up
- MeSH terms
- Adult, Aged, Aged, 80 and over, Basal Cell Carcinoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Double-Blind Method, Female, Humans, Male, Middle Aged, Niacinamide, Skin Neoplasms, Vitamin B Complex, Secondary Prevention, Keratosis, Actinic
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