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Nicotinamide in the Treatment of Psoriasis

Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Calcipotriol plus Nicotinamide (Drug); Calcipotriol (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Isfahan University of Medical Sciences

Official(s) and/or principal investigator(s):
Mehdi Khodadadi, MD, Principal Investigator, Affiliation: Isfahan University of Medical Sciences

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Psoriasis severity

Secondary outcome: Patient's satisfaction

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Related 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.

Starting date: July 2011
Last updated: January 5, 2013

Page last updated: August 23, 2015

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