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Journal of the American Academy of Dermatology
Volume 63, n° 5
pages 775-781 (novembre 2010)
Doi : 10.1016/j.jaad.2009.10.016
accepted : 20 October 2009
Original Articles

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

Danielle Levine, BA a, Zeev Even-Chen, PhD b, Irina Lipets, MSN, RN c, Olga A. Pritulo, MD, PhD d, Tetyana V. Svyatenko, MD, PhD e, Yuri Andrashko, MD, PhD f, Mark Lebwohl, MD g, Alice Gottlieb, MD, PhD a,
a Department of Dermatology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts 
b Dermipsor, Rehovot, Israel 
c Global Clinical Operations PharmaEdge Research, Lakewood, New Jersey 
d Crimean Medical University, Simferopol, Ukraine 
e Dniepropetrovsk State Medical Academy, Dniepropetrovsk, Ukraine 
f P. L. Shupik’s National Academy of Postgraduate Education, Kiev, Ukraine 
g Department of Dermatology, Mount Sinai School of Medicine, New York, New York 

Reprint requests: Alice Gottlieb, MD, PhD, Department of Dermatology, Tufts Medical Center, 800 Washington St, Box 114, Boston, MA 02111.
Abstract
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.

The full text of this article is available in PDF format.

Key words : calcipotriene, nicotinamide, psoriasis, topical psoriasis treatment, randomized control trial



 Supported by Dermipsor Ltd.
 Disclosure: Almost all of Dr Gottlieb’s income is paid to her employer directly. Dr. Gottlieb serves on speakers bureaus for Amgen Inc and Wyeth Pharmaceuticals; she has consulting/advisory board agreements with Amgen Inc, Centocor Inc, Wyeth Pharmaceuticals, Celgene Corp, Bristol Myers Squibb Co, Beiersdorf Inc, Warner Chilcott, Abbott Laboratories, Roche, Sankyo, Medarex, Kemia, Celera, TEVA, Actelion, UCB, Novo Nordisk, Almirall, Immune Control, RxClinical, Dermipsor Ltd, Medacorp, Dermipsor, Can-Fite, Incyte, Corgentech, Pure-Tech, Magen Biosciences, and Cytokine Pharmasciences Inc; and she is the recipient of research/educational grants from Centocor, Amgen, Wyeth Pharmaceuticals, Immune Control, Celgene, Incyte, Abbott Laboratories, Pfizer, and NovoNordisk. Members of Dr Lebwohl’s department own patents on short-contact tazarotene, topical genistein, and use of the excimer laser for vitiligo; he serves on speakers bureaus for Abbott Laboratories, Amgen Inc, Centocor, Galderma, Genentech, PharmaDerm, Stiefel, and Warner Chilcott; he has advisory board agreements with Abbott Laboratories, Amgen Inc, Astellas, Centocor Inc, Galderma, Genentech, Medicis, Novartis, Stiefel, and Warner Chilcott; he is a consultant for Dermipsor, PharmaDerm, Sanofi-Aventis, Triax, and York Pharma. Dr Even-Chen is an employee of Dermipsor. Ms Levine, Ms Lipets, Dr Pritulo, Dr Svyatenko, and Dr Andrashko have no conflicts of interest to declare.



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