Nicotinamide in the Treatment of Psoriasis

Evaluation of Topical Nicotinamide in Combination With Calcipotriol Compared With Calcipotriol Alone for the Treatment of Mild to Moderate Psoriasis.

This study will determine if combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Calcipotriol; Drug: Calcipotriol plus Nicotinamide

Detailed Description

Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. Preliminary studies have shown that nicotinamide, which is a vitamin B derivative, is effective in the treatment of psoriasis. According to lack of data, we will investigate the beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate psoriasis.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Skin Diseases and Leishmaniasis Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women of 18 to 65 years old,
• Mild to moderate psoriasis; patients must have had less than 15% of the involved body surface, symmetrical plaques (bilateral lesions) or two plaques at least 5 cm apart on the same side of the body with plaque size greater than 2 × 2 cm, but smaller than 15 × 15 cm.
• Willingness to participate

Exclusion Criteria:

• Those who used any medication or niacin and multi-vitamins two weeks, or anti-psoriatic systemic drugs or beta-blockers one month prior to the study,
• Pregnant women,
• Those with the history of renal, hematologic, liver and major psychiatric diseases,
• Those with only scalp, nail, flexural, palmoplantar, or pustular psoriasis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Calcipotriol; Patients applied calcipotriol 0.005% (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of the other side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.	Drug: Calcipotriol; Patients applied calcipotriol 0.005% (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of the other side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.
Experimental: Calcipotriol plus Nicotinamide; Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.	Drug: Calcipotriol plus Nicotinamide; Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis severity	Patients are visited by a dermatologist at baseline and then after the first and third month of therapy, and psoriasis severity is evaluated using the modified psoriasis area and severity index.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction	Patient's satisfaction is evaluated at the end of the trial using a 10-point rating scale.	After 3 months

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Mehdi Khodadadi, MD, Isfahan University of Medical Sciences

Publications and helpful links

General Publications

• Levine D, Even-Chen Z, Lipets I, Pritulo OA, Svyatenko TV, Andrashko Y, Lebwohl M, Gottlieb A. Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):775-81. doi: 10.1016/j.jaad.2009.10.016.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 5, 2013
• First Submitted That Met QC Criteria: January 5, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 5, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Dermatologic Agents; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin B Complex; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Nicotinic Acids; Niacinamide; Niacin; Calcitriol
• Other Study ID Numbers: 390134