- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624544
Proton Pump Inhibitors Use in Patients With Psoriasis
August 3, 2022 updated by: EMS
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.
Study Overview
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
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnostic of Psoriasis
Exclusion Criteria:
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Proton Pump Inhibitor esomeprazole 40 mg twice a day
|
esomex 40 mg twice daily
Other Names:
|
|
Active Comparator: Group B
desonide
|
topical corticosteroid desonid 0,1% b.i.d
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline - 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 13, 2015
First Submitted That Met QC Criteria
December 7, 2015
First Posted (Estimate)
December 8, 2015
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.