Niacinamide Clinical Evidence

European Journal of Dermatology

Drago F, et al. Prevention of non-melanoma skin cancers with nicotinamide in transplant recipients: a case-control study. 2017 Aug 1;27(4):382-85.

Topic:

Can nicotinamide, a form of vitamin B3, help treat and prevent actinic keratosis (AKs) in transplant recipients?

Background:

AKs are pre-cancerous skin lesions. Nicotinamide has been reported to be effective in preventing AKs and new non-melanoma skin cancers (NMSCs).

Study Type:

Human clinical intervention trial

Study Design: 

Case control. Participants were randomly divided into treatment and control groups of 19 each. The treatment group took nicotinamide daily for 6 months, while the control group took nothing. All participants’ AKs were identified, measured, and photographed at baseline and at the end of the study.

Dosage:

500 mg/day

Participants: 

38 transplant (8 liver and 30 kidney) recipients with at least one AK

Results:

At baseline, there were no statistically significant differences between the two groups. After 6 months, AKs in the treatment group had significantly decreased in size in all but one participant (88%). Of these, 7 (42%) met the criteria for complete clinical regression. No participant in the treatment group developed new AKs. However, in the control group, 91% of participants experienced an increase in AK size and/or developed new AKs. Seven of the pre-existing AKs progressed to squamous cell carcinoma.

Conclusion:

“Nicotinamide appears to be effective in preventing and treating AKs, although the mechanism is still unclear.”

The Journal of Investigative Dermatology

Surjana D, et al. Oral nicotinamide reduces actinic keratoses in phase II double-blinded randomized controlled trials. 2012 May;132(5):1497-500.

Topic:

Can nicotinamide help reduce actinic keratoses (AKs)?

Background:

Nicotinamide has been shown to protect against skin cancer in animal research. Can it work in humans?

Study Type:

Human clinical intervention trial

Study Design:

Randomized, double-blind, placebo-controlled. Participants took nicotinamide either once or twice a day for 4 months. They underwent a skin examination at baseline and were encouraged to wear sunscreen throughout the study period. Researchers conducted additional skin examinations at 2 and 4 months to identify AKs and graph them on a body grid chart. At baseline and 2 months, researchers measured blood count, creatine, and liver function.

Dosage:

500 or 1,000 mg/day

Participants:

74 healthy, immune-competent volunteers with more than 4 AKs on the face, scalp, or arms

Results:

Participants in the 1,000 mg group experienced a 35% relative reduction in AK count at 4 months, with similar results at 2 months. Those in the 500 mg group experienced a 29% reduction at 4 months, with a smaller but significant reduction at 2 months. At baseline, 81% of participants in the high-dose group and 79% of those in the low-dose group had previous diagnosed skin cancers. During the study period, 11 volunteers in the placebo group developed 20 new cancers (basal cell carcinoma and squamous cell carcinoma), while 2 volunteers in the treatment group developed 4 new cancers (also basal cell carcinoma and squamous cell carcinoma). There were no significant side effects

Conclusions:

“The odds of developing at least one new skin cancer was significantly lower with nicotinamide…as was the rate of new skin cancers.”

Carcinogenesis

Yiasamides E, et al. Oral nicotinamide protects against ultraviolet radiation-induced immunosuppression in humans. 2009 Jan;30(1):101-05.

Topic:

Can nicotinamide protect the skin against the immunosuppressive effects of UV radiation?

Background:

Even small amounts of UV radiation suppress cutaneous immunity, which protects the skin against skin cancer. Can nicotinamide help?

Study Type:

Human clinical intervention trial

Study Design: 

Randomized, double-blind, placebo-controlled crossover.  Participants took nicotinamide or placebo for 1 week. Areas of their backs were irradiated with low doses of UV radiation on 3 consecutive days, after which the researchers calculated immunosuppression at irradiated and unirradiated sites in both the control and placebo groups.

Dosage:

500 or 1,500 mg/day

Participants: 

Healthy volunteers

Results:

Researchers found significant evidence of immunosuppression in irradiated sites in the placebo group. Nicotinamide significantly reduced immunosuppression at both doses.

Conclusions:

“Oral nicotinamide at doses of either 1,500 or 500 mg daily, was well tolerated and significantly reduced UV immunosuppression with no immune effects in unirradiated skin. Oral nicotinamide is safe and inexpensive and looks promising as a chemopreventive supplement for reducing the immunosuppressive effects of sunlight.”

Mechanism of Action:

Nicotinamide’s mechanism of action is not yet completely understood. As a precursor of nicotinamide adenine dinucleotide (NAD), nicotinamide prevents the decline in cellular energy seen after exposure to UV radiation. This action could support cells’ DNA repair activity. Nicotinamide also helps prevent immunosuppression following exposure to the UV light that leaves cells vulnerable to cancer.