NCT02624544

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

Same day

First QC Date

November 13, 2015

Last Update Submit

August 3, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline - 5 months

Study Arms (2)

Group A

EXPERIMENTAL

Proton Pump Inhibitor esomeprazole 40 mg twice a day

Drug: esomeprazole

Group B

ACTIVE COMPARATOR

desonide

Drug: desonide

Interventions

esomeprazoleDRUG

esomex 40 mg twice daily

Also known as: esomex
Group A
desonideDRUG

topical corticosteroid desonid 0,1% b.i.d

Also known as: corticosteroid
Group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnostic of Psoriasis

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22463723RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

EsomeprazoleDesonideAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

December 8, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

August 5, 2022

Record last verified: 2022-08