Back to resultsProton Pump Inhibitors Use in Patients With Psoriasis
Primary Purpose
Psoriasis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
esomeprazole
desonide
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Diagnostic of Psoriasis
Exclusion Criteria:
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Proton Pump Inhibitor esomeprazole 40 mg twice a day
desonide
Outcomes
Primary Outcome Measures
Efficacy - Change from baseline in skin lesions at 5 months
Number of Participants With Treatment-Related Clinical Improvement of lesions Change From Baseline in skin lesions at 5 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02624544
Brief Title
Proton Pump Inhibitors Use in Patients With Psoriasis
Official Title
Proton Pump Inhibitors Use in Patients With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Proton Pump Inhibitor esomeprazole 40 mg twice a day
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
desonide
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
esomex
Intervention Description
esomex 40 mg twice daily
Intervention Type
Drug
Intervention Name(s)
desonide
Other Intervention Name(s)
corticosteroid
Intervention Description
topical corticosteroid desonid 0,1% b.i.d
Primary Outcome Measure Information:
Title
Efficacy - Change from baseline in skin lesions at 5 months
Description
Number of Participants With Treatment-Related Clinical Improvement of lesions Change From Baseline in skin lesions at 5 months
Time Frame
Baseline - 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic of Psoriasis
Exclusion Criteria:
Pregnancy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22463723
Citation
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. doi: 10.2174/187153012802002901.
Results Reference
result
Learn more about this trial
Proton Pump Inhibitors Use in Patients With Psoriasis
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