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

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.

• Authors: Danielle Levine, Zeev Even-Chen, Irina Lipets, Olga A Pritulo, Tetyana V Svyatenko, Yuri Andrashko, Mark Lebwohl, Alice Gottlieb
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 63 Issue 5 Pg. 775-81 (Nov 2010) ISSN: 1097-6787 [Electronic] United States
• PMID: 20599292 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Chemical References

• Dermatologic Agents
• Placebos
• Vitamin B Complex
• calcipotriene
• Niacinamide
• Calcitriol

Topics

• Adult
• Calcitriol (administration & dosage, adverse effects, analogs & derivatives)
• Dermatologic Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Synergism
• Drug Therapy, Combination
• Female
• Humans
• Male
• Niacinamide (administration & dosage, adverse effects)
• Pilot Projects
• Placebos
• Psoriasis (drug therapy)
• Treatment Outcome
• Vitamin B Complex (administration & dosage)