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
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