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Proton Pump Inhibitors Use in Patients With Psoriasis

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ClinicalTrials.gov Identifier: NCT02624544
Recruitment Status : Unknown
Verified November 2015 by EMS.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE November 13, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date December 8, 2015
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Efficacy - Change from baseline in skin lesions at 5 months [ Time Frame: Baseline - 5 months ]
Number of Participants With Treatment-Related Clinical Improvement of lesions Change From Baseline in skin lesions at 5 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Pump Inhibitors Use in Patients With Psoriasis
Official Title  ICMJE Proton Pump Inhibitors Use in Patients With Psoriasis
Brief Summary Proton pump inhibitors act in blocking acid secretion and also have antioxidant and anti-inflammatory properties. For that mechanisms possibly PPIs may have an anti-inflammatory action with improvement in skin lesions in patients with psoriasis.
Detailed Description

Proton pump inhibitors act in blocking acid secretion and also have antioxidant and anti-inflammatory properties. For that mechanisms possibly PPIs may have an anti-inflammatory action with improvement in skin lesions in patients with psoriasis.

The study will assess the evolution of skin lesions in psoriasis patients using PPIs

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: esomeprazole
    esomex 40 mg twice daily
    Other Name: esomex
  • Drug: desonide
    topical corticosteroid desonid 0,1% b.i.d
    Other Name: corticosteroid
Study Arms  ICMJE
  • Experimental: Group A
    Proton Pump Inhibitor esomeprazole 40 mg twice a day
    Intervention: Drug: esomeprazole
  • Active Comparator: Group B
    desonide
    Intervention: Drug: desonide
Publications * Rahman M, Alam K, Ahmad MZ, Gupta G, Afzal M, Akhter S, Kazmi I, Jyoti, Ahmad FJ, Anwar F. Classical to current approach for treatment of psoriasis: a review. Endocr Metab Immune Disord Drug Targets. 2012 Sep;12(3):287-302. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnostic of Psoriasis

Exclusion Criteria:

  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624544
Other Study ID Numbers  ICMJE EMS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EMS
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP