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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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“, patients who had at least two non melanoma skin cancers (NMSCs) in the previous 5 years [59].”
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“Epstein–Barr virus), antiviral therapies [21], supplements (nicotinamide) [28] and promotion of healthier lifestyles (diet, smoking cessation, etc.”
Alternative Behandlungsoptionen beim Basalzellkarzinom am Auge
Kakkassery, V., Emmert, S., Adamietz, I. U. A., Kovács, G., Jünemann, A., Otte, C., Zimbelmann, M., Brosig, A., Grisanti, S., & Heindl, L. M. (2019) · Der Ophthalmologe · doi:10.1007/s00347-019-01021-4 · Cited by 14
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“Because Nam is known to inhibit poly-ADP-ribose-polymerase-1 (PARP-1) and regulate DNA repair, it has potential as a prophylaxis against nonmelanoma skin cancer [27,28].”
Role of SIRT3 in bone homeostasis and its application in preventing and treating bone diseases
Xu, K., Li, J., Wen, R., Chang, B., Cheng, Y., & Yi, X. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2023.1248507 · Cited by 15
de Troya-Martín, M., Martínez, A. R., Rivas‐Ruiz, F., Subert, A., Arellano‐Mendoza, M. I., Calzavara‐Pinton, P., de Gálvez, M. V., Gilaberte, Y., Goh, C., Lim, H. W., et al. (2025) · Photodermatology Photoimmunology & Photomedicine · doi:10.1111/phpp.70001 · Cited by 15
Primary and Secondary Chemoprevention of Malignant Melanoma
Mounessa, J. S., Buntinx-Krieg, T., Qin, R., Dunnick, C. A., & Dellavalle, R. P. (2016) · American Journal of Clinical Dermatology · doi:10.1007/s40257-016-0221-5 · Cited by 13
“While numerous studies demonstrate their chemopreventive properties against KCs in high-risk patients, literature on their role against MM is scarce [17].”
BackgroundInfluentialMcCaskill‐Stevens, W., Pearson, D. C., Kramer, B. S., Ford, L. G., & Lippman, S. M. (2016) · Cancer Prevention Research · doi:10.1158/1940-6207.capr-16-0230 · Cited by 14
“Chen and colleagues reported that oral nicotinamide was safe and effective in reducing the rates of newnonmelanoma skin cancer and actinic keratosis in high-risk patients (30).”
BackgroundUV and Skin: Photocarcinogenesis
Oak, A. S. W., Athar, M., Yusuf, N., & Elmets, C. A. (2017) · Springer eBooks · doi:10.1007/978-3-319-43102-4_8 · Cited by 14
A Topical Zinc Ionophore Blocks Tumorigenic Progression in UV‐exposed SKH‐1 High‐risk Mouse Skin
Justiniano, R., Perer, J., Hua, A., Fazel, M., Krajisnik, A., Cabello, C. M., & Wondrak, G. T. (2017) · Photochemistry and Photobiology · doi:10.1111/php.12794 · Cited by 13
Current Therapeutic Strategies of Xeroderma Pigmentosum
Hossain, M., Hasan, M. A., Shawan, M. M. A. K., Banik, S., & Jahan, I. (2021) · Indian Journal of Dermatology · doi:10.4103/ijd.ijd_329_21 · Cited by 15
“Chen et al. [40] showed that an intake of 500 mg nicotinamide twice daily for 1 year by dermatology patients reduced the rate of incidences of non-melanoma skin cancer, BCC, and SCC as opposed to the dermatology patients who took placebos.”
Deleterious side effects of nutritional supplements
Anselmo, F., & Driscoll, M. S. (2021) · Clinics in Dermatology · doi:10.1016/j.clindermatol.2021.05.002 · Cited by 12
Maemoto, Y., Shimizu, Y., Katoh, R., & Ito, A. (2021) · The Journal of Antibiotics · doi:10.1038/s41429-021-00459-6 · Cited by 13
Oh, the Mutations You’ll Acquire! A Systematic Overview of Cutaneous Squamous Cell Carcinoma
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“This safe and cheap drug reduces AK lesions [17] and cSCC occurrence by 30% in immunocompetent patients [18].”
BackgroundOral nicotinamide for non-melanoma skin cancers: A review
Hunt, S. V., Jamison, A., & Malhotra, R. (2022) · Eye · doi:10.1038/s41433-022-02036-z · Cited by 12
“[16] phase III trial in immunocompetent individuals, and identified statistically significantly higher rates of mucocutaneous infections within the group receiving oral nicotinamide, though the original authors believe this falls within the realms of chance, highlighting that non-mucocutaneous infection rates were hig…”
BackgroundCorsi, F., Meo, E. D., Lulli, D., Tarquini, G. D., Capradossi, F., Bruni, E., Pelliccia, A., Traversa, E., Dellambra, E., Failla, C. M., et al. (2023) · Antioxidants · doi:10.3390/antiox12030757 · Cited by 12
“However, epidemiology studies point out that protection hardly applies to the long-term effects of exposure, such as carcinogenesis [25,26].”
BackgroundSystemic Photoprotection in Skin Cancer Prevention: Knowledge among Dermatologists
Fania, L., Sampogna, F., Ricci, F., Hyeraci, M., Paradisi, A., Palese, E., Lella, G. D., Pallotta, S., Panebianco, A., Candi, E., et al. (2021) · Biomolecules · doi:10.3390/biom11020332 · Cited by 12
“A phase-three randomized controlled trial, carried out on 386 Australians, showed that oral nicotinamide treatment for 12 months (500 mg twice daily) was safe and effective in reducing the rates of new NMSC [7].”
BackgroundCutaneous β HPVs, Sun Exposure, and Risk of Squamous and Basal Cell Skin Cancers in Australia
Kricker, A., Weber, M. F., Pawlita, M., Sitas, F., Hodgkinson, V. S., Rahman, B., van Kemenade, C. H., Armstrong, B. K., & Waterboer, T. (2021) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-21-1000 · Cited by 12
Self-citationThe role of sirtuins in dermal fibroblast function
Gilbert, M. M., Mathes, S. C., Mahajan, A. S., Rohan, C. A., Travers, J. B., & Thyagarajan‐Sahu, A. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2023.1021908 · Cited by 15
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Lactate: A Theranostic Biomarker for Metabolic Psychiatry?
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Xu, Y., Lu, A., Guan, X., Ying, T., Pan, J., Tan, M., & Lu, J. (2024) · Food Frontiers · doi:10.1002/fft2.511 · Cited by 11
Nutrition and Diet Patterns as Key Modulators of Metabolic Reprogramming in Melanoma Immunotherapy
Grafanaki, K., Maniatis, A., Anastogianni, A., Bania, A., Pasmatzi, E., & Stathopoulos, C. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14124193 · Cited by 12
“In contrast, niacin (Vitamin B3), despite its protective role against photosensitivity, has shown no significant association with melanoma risk [127–130].”
Stratigos, A. J., Dessinioti, C., Garbe, C., Lebbé, C., Amaral, T., Bataille, V. A., Dréno, B., Dummer, R., Fargnoli, M. C., Forsea, A., et al. (2026) · European Journal of Cancer · doi:10.1016/j.ejca.2026.116763 · Cited by 11
Pihl, C., Bendtsen, K. M., Jensen, H. E., Andersen, F., Bjerring, P., Hædersdal, M., & Lerche, C. M. (2023) · Journal of Photochemistry and Photobiology B Biology · doi:10.1016/j.jphotobiol.2023.112760 · Cited by 11
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“…of sirtuins have been proposed for use in the treatment of cancer and other diseases (Demarin et al. 2004; Lara et al. 2009; Chopra et al. 2012; Chen et al. 2015; Cheon et al. 2015), but little is known about the specificity of these drugs or the consequences of inhibiting multiple sirtuins…”
BackgroundThe role of DNA damage as a therapeutic target in autosomal dominant polycystic kidney disease
Zhang, J. Q. J., Saravanabavan, S., Munt, A., Wong, A. T. Y., Harris, D. C. H., Harris, P. C., Wang, Y., & Rangan, G. K. (2019) · Expert Reviews in Molecular Medicine · doi:10.1017/erm.2019.6 · Cited by 12
Warnig, C., & Wollina, U. (2021) · Dermatologic Therapy · doi:10.1111/dth.14992 · Cited by 10
“Patients with SCC and other non-melanoma skin cancers have a decreased DNA repair capacity.(12,13) UV exposure in outdoor workers is a major factor in occupationrelated cutaneous SCC and actinic keratoses.”
BackgroundThe Role of Dietary Antioxidants in Melanoma and Nonmelanoma Skin Cancer
Sable, K. A. (2023) · Cutis · doi:10.12788/cutis.0672 · Cited by 12
Commentary: Facial Aesthetic Dermatological Procedures and Photoprotection in Chinese Populations
Liu, W., Krutmann, J., Tian, Y., Granger, C., Piquero-Casals, J., Trullàs, C., Passeron, T., Lim, H., & Lai, W. (2022) · Dermatologic Therapy · doi:10.1007/s13555-022-00862-3 · Cited by 12
“Nicotinamide (vitamin B3) is a safe, widelyavailable vitamin that reduces the immunosuppressive effects of UV, enhances DNA repair in keratinocytes, and has shown promise in the chemoprevention of nonmelanoma skin cancer (dose of 500 mg twice daily) [88, 89].”
BackgroundNicotinamide for Skin-Cancer Chemoprevention in Transplantation
Schmults, C. D., Jambusaria-Pahlajani, A., & Ruiz, E. (2023) · New England Journal of Medicine · doi:10.1056/nejmc2303841 · Cited by 11
A review of heart transplant immunosuppressants and nonmelanoma skin cancer
Eckembrecher, D. G., Eckembrecher, F. J., Camacho, I., Shah, H., Dave, Y., Patel, S. D., & Nouri, K. (2023) · Archives of Dermatological Research · doi:10.1007/s00403-023-02646-x · Cited by 10
Current management of nonmelanoma skin cancers
Dugan, M. M., Shannon, A. B., DePalo, D. K., Tsai, K. Y., Farma, J. M., Gonzalez, R. J., & Zager, J. S. (2024) · Current Problems in Surgery · doi:10.1016/j.cpsurg.2024.101565 · Cited by 10
The evolving landscape of laser-based skin cancer prevention
Wenande, E. C., Wanner, M. A., Sakamoto, F. H., Paasch, U., & Hædersdal, M. (2025) · Lasers in Medical Science · doi:10.1007/s10103-025-04327-9 · Cited by 10
“Particularly relevant in high-risk populations, the systemic agents nicotinamide and acitretin, reduce development rate of KC and the most common precursor, actinic keratosis (AK) [11 ], but do not offer lasting prophylactic effects upon discontinuation [ 12].”
Immune Checkpoint Inhibitors in Field Cancerization and Keratinocyte Cancer Prevention
Cox, C., Brown, S., Walpole, E. T., Roy, E., Dousset, L., Ladwa, R., & Khosrotehrani, K. (2025) · JAMA Dermatology · doi:10.1001/jamadermatol.2024.5750 · Cited by 10
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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