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CompletedNCT01763424Updated Jan 8, 2013

Nicotinamide in the Treatment of Psoriasis

A Phase 2/3 interventional study of Calcipotriol plus Nicotinamide and Calcipotriol in Psoriasis, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-08.

Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugCalcipotriol 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.

  • DrugCalcipotriol

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 3 months

Secondary outcomes

  1. Patient's satisfaction

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

    Time frame: After 3 months

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Study locations

1 site
  • Skin Diseases and Leishmaniasis Research Center
    Isfahan, Iran, Islamic Republic of
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References and documents

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. PubMed 20599292 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01763424
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Dr. Mehdi Khodadadi (Dr., Isfahan University of Medical Sciences) — Principal investigator
First posted
Jan 8, 2013
Start date
Jul 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jan 8, 2013

Study contacts

Mehdi Khodadadi, MD
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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