Clinical Trials

A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention

Andrew C. Chen, M.B., B.S., Andrew J. Martin, Ph.D., Bonita Choy, M.Med., Pablo Fernández-Peñas, Ph.D., Robyn A. Dalziell, Ph.D., Catriona A. McKenzie, M.B., B.S., Richard A. Scolyer, M.D., Haryana M. Dhillon, Ph.D., Janette L. Vardy, M.D., Anne Kricker, Ph.D., Gayathri St. George, M.Sc.Med., Niranthari Chinniah, M.B., B.S., Gary M. Halliday, D.Sc., and Diona L. Damian, Ph.D.

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)..

Oral Nicotinamide Reduces Actinic Keratoses in Phase II Double-Blinded Randomized Controlled Trials

Devita Surjana, Gary M. Halliday, Andrew J. Martin, Fergal J. Moloney, Diona L. Damian

A 35% relative reduction in AK count at 4 months (95% confidence interval (CI): 18–48%; P=0.0006) was estimated from Study 1 (with similar results at 2 months). A 29% relative reduction in AK count at 4 months (95% CI: 11–44%; P=0.005) was estimated from Study 2 (with smaller but significant differences observed at 2 months). There was no evidence that the relative effect of nicotinamide was modified by baseline AK count (treatment-by-baseline interaction P-value was nonsignificant).

Enzyme plus light therapy to repair DNA damage in ultraviolet-B-irradiated human skin

Helger Stege, Len Roza, Arie A. Vink, Markus Grewe, Thomas Ruzicka, Susanne Grether-Beck, and Jean Krutmann

When a dose of UVB radiation sufficient to induce erythema was administered to the skin of healthy subjects, significant numbers of dimers were formed within epidermal cells. Topical application of photolyase-containing liposomes to UVB-irradiated skin and subsequent exposure to photoreactivating light decreased the number of UVB radiation-induced dimers by 40-45%