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Body PSOriasis: Long-term Relapse CONTROL (PSO-CONTROL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402828
Recruitment Status : Active, not recruiting
First Posted : January 18, 2018
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:
This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Drug: Any topical drug treatment

Study Design
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Study Type : Observational
Actual Enrollment : 764 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body PSOriasis: Long-term Relapse Control in Patients With Psoriasis Vulgaris in Daily Clinical Practice of Russian Dermatologists.
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Intervention Details:
  • Drug: Any topical drug treatment
    Any treatment strategy used to prevent relapse of psoriasis symptoms
    Other Name: Non-drug topicals

Outcome Measures
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Primary Outcome Measures :
  1. Time of relapse [ Time Frame: Up to 52 weeks ]
    Length of relapse free period after start of maintenance strategy


Secondary Outcome Measures :
  1. Dermatology Life Quality Index [ Time Frame: Up to 52 weeks ]
    Standard QoL measure within dermatology

  2. PGA (physician's global assessment of symptoms) [ Time Frame: Up to 52 weeks ]
    5-point verbal rating scale

  3. PsGA (patient's global assessment of symptoms) [ Time Frame: Up to 52 weeks ]
    5-point verbal rating scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with psoriasis vulgaris attending one of the participating outpatient dermatology clinics entering a phase of prevention of relapse of psoriasis symptoms.
Criteria

Inclusion Criteria:

  • Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
  • Written informed consent

Exclusion Criteria:

  • Contraindications to selected treatment
  • Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402828


Locations
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Russian Federation
The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan
Kazan, Tatarstan, Russian Federation, 420012
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Dmitry Petrunin, MD PhD Leo Pharmaceutical Products LLC
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03402828    
Other Study ID Numbers: NIS-PSORIASIS-1379
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LEO Pharma:
Topicals
Long-term
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases