Skip to main content
OpenTrials
Completed

NCT Number: NCT01763424

Nicotinamide in the Treatment of Psoriasis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Skin Diseases and Leishmaniasis Research Center

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcipotriol plus Nicotinamide

Drug

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

Drug

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 outcomes

  1. Psoriasis severity

    Time frame: 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 outcomes

  1. Patient's satisfaction

    Time frame: After 3 months

    Patient's satisfaction is evaluated at the end of the trial using a 10-point rating scale.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 8, 2013
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.