Nicotinamide in the Treatment of Psoriasis

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Calcipotriol plus Nicotinamide; Drug: Calcipotriol

• Registration Number: NCT01763424
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2011-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-05
• Study First Submitted QC: 2013-01-05
• Last Update Submitted: 2013-01-05
• Study First Posted: 2013-01-08
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriol plus Nicotinamide	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	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.

Primary Outcome Measures

Name	Time	Method
Psoriasis severity	Up to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction	After 3 months	Patient's satisfaction is evaluated at the end of the trial using a 10-point rating scale.

Trial Locations

Locations (1)

Skin Diseases and Leishmaniasis Research Center; 🇮🇷 Isfahan, Iran, Islamic Republic of