Nicotinamide in the Treatment of Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763424
• Other study ID #: 390134
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 5, 2013
• Last updated: January 5, 2013
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Skin Diseases and Leishmaniasis Research Center	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient's satisfaction	Patient's satisfaction is evaluated at the end of the trial using a 10-point rating scale.	After 3 months	No