Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis

• Published in: Journal of the American Academy of Dermatology 2010-11, Vol.63 (5), p.775-781
• Main Authors: Levine, Danielle, BA, Even-Chen, Zeev, PhD, Lipets, Irina, MSN, RN, Pritulo, Olga A., MD, PhD, Svyatenko, Tetyana V., MD, PhD, Andrashko, Yuri, MD, PhD, Lebwohl, Mark, MD, Gottlieb, Alice, MD, PhD
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; calcipotriene; Calcitriol - administration & dosage; Calcitriol - adverse effects; Calcitriol - analogs & derivatives; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatology; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Humans; Male; Medical sciences; Niacinamide - administration & dosage; Niacinamide - adverse effects; nicotinamide; Pilot Projects; Placebos; psoriasis; Psoriasis - drug therapy; Psoriasis. Parapsoriasis. Lichen; randomized control trial; topical psoriasis treatment; Treatment Outcome; Vitamin B Complex - administration & dosage
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2009.10.016

Background Calcipotriene has limited efficacy in treating psoriasis. By inhibiting proinflammatory cytokines such as interleukin-12, interleukin-23, and tumor necrosis factor-alfa, nicotinamide may enhance the efficacy of calcipotriene therapy when used in combination. Objective We sought to determine if the combination of nicotinamide with calcipotriene is more effective than either component alone. Methods In this randomized, double-blinded, multicenter 7-arm bilateral comparison-controlled trial, patients were randomized to two of 7 treatments–placebo, calcipotriene 0.005% alone, nicotinamide 1.4% alone, calcipotriene plus nicotinamide 0.05%, calcipotriene plus nicotinamide 0.1%, calcipotriene plus nicotinamide 0.7%, or calcipotriene plus nicotinamide 1.4%–each administered to lesions on one side of the body or to one of two lesions at least 5 cm apart, for 12 weeks. Efficacy was measured using a clear to almost clear outcome. Results In all, 50.0% of patients in the calcipotriene and nicotinamide 1.4% combination group achieved a clear to almost clear outcome at week 12, compared with only 18.8% of patients treated with placebo ( P = .002), 25% of patients treated with nicotinamide 1.4% alone ( P = .02), and 31.5% of patients treated with calcipotriene alone ( P = .096). A dose-response trend existed for increasing concentrations of nicotinamide, but it was not significant. Limitations The relatively small patient numbers, relatively high placebo effect, and maximum in-life portion of only 12 weeks of dosing are weaknesses of the study. Conclusion This study provides evidence that using the combination nicotinamide and calcipotriene may provide additional benefit in the topical treatment for patients with psoriasis and may be an adequate steroid-sparing substitute treatment.