PsoriasisPhase 4NCT02624544
Proton Pump Inhibitors Use in Patients With Psoriasis
A Phase 4 study testing esomeprazole and desonide in people with Psoriasis, run by EMS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- esomeprazole and desonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic of Psoriasis
Who cannot join
- Pregnancy
About this study
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.
Read the 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
- Conditions
- Psoriasis
- Being tested
- esomeprazole, desonide
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called esomex
esomex 40 mg twice daily
desonideDrug
Also called corticosteroid
topical corticosteroid desonid 0,1% b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Proton Pump Inhibitor esomeprazole 40 mg twice a day Receives: Drug: esomeprazole |
| Group B | Active comparator | desonide Receives: Drug: desonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624544
- Sponsor's protocol ID
- EMS
- Status last verified
- Aug 2022
- First submitted
- 13 Nov 2015
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.2174/187153012802002901.
PubMed 22463723
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitors Use in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02624544
- Acronym / sponsor ID
- EMS
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: esomeprazoleProton Pump Inhibitor esomeprazole 40 mg twice a day |
| Group B | Active comparator | Drug: desonidedesonide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnostic of Psoriasis
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esomeprazoleAlso: esomexesomex 40 mg twice daily | Drug | Group A |
| desonideAlso: corticosteroidtopical corticosteroid desonid 0,1% b.i.d | Drug | Group B |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Results publication: PubMed 22463723Rahman 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.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole and desonide in people with Psoriasis, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Change from baseline in skin lesions at 5 months (time frame: Baseline - 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02624544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.