Nicotinamide in the Treatment of Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Mehdi Khodadadi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01763424
First received: January 5, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: Calcipotriol plus Nicotinamide
Drug: Calcipotriol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Topical Nicotinamide in Combination With Calcipotriol Compared With Calcipotriol Alone for the Treatment of Mild to Moderate Psoriasis.

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Psoriasis severity [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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:
  • Patient's satisfaction [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
    Patient's satisfaction is evaluated at the end of the trial using a 10-point rating scale.


Enrollment: 66
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Experimental: 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.
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763424

Locations
Iran, Islamic Republic of
Skin Diseases and Leishmaniasis Research Center
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Mehdi Khodadadi, MD Isfahan University of Medical Sciences
  More Information

Publications:
Responsible Party: Dr. Mehdi Khodadadi, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01763424     History of Changes
Other Study ID Numbers: 390134
Study First Received: January 5, 2013
Last Updated: January 5, 2013
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Niacinamide
Niacin
Nicotinic Acids
Calcitriol
Calcipotriene
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on April 17, 2014