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Proton Pump Inhibitors Use in Patients With Psoriasis

Sponsor
EMS (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02624544
Collaborator
(none)
0
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Proton Pump Inhibitors Use in Patients With Psoriasis
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Proton Pump Inhibitor esomeprazole 40 mg twice a day

Drug: esomeprazole
esomex 40 mg twice daily
Other Names:
  • esomex

    		•
    Active Comparator: Group B

    desonide

    Drug: desonide
    topical corticosteroid desonid 0,1% b.i.d
    Other Names:
  • corticosteroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy - Change from baseline in skin lesions at 5 months [Baseline - 5 months]

      Number of Participants With Treatment-Related Clinical Improvement of lesions Change From Baseline in skin lesions at 5 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnostic of Psoriasis
    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT02624544
    Other Study ID Numbers:
    • EMS
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Psoriasis
    Desonide
    Esomeprazole

    Study Results

    No Results Posted as of Aug 5, 2022