NCT03402828

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
764

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

March 16, 2021

Status Verified

December 1, 2019

Enrollment Period

1.9 years

First QC Date

January 11, 2018

Last Update Submit

March 15, 2021

Conditions

Psoriasis Vulgaris

Keywords

TopicalsLong-term

Outcome Measures

Primary Outcomes (1)

  • Time of relapse

    Length of relapse free period after start of maintenance strategy

    Up to 52 weeks

Secondary Outcomes (3)

  • Dermatology Life Quality Index

    Up to 52 weeks

  • PGA (physician's global assessment of symptoms)

    Up to 52 weeks

  • PsGA (patient's global assessment of symptoms)

    Up to 52 weeks

Interventions

Any topical drug treatmentDRUG

Any treatment strategy used to prevent relapse of psoriasis symptoms

Also known as: Non-drug topicals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Contraindications to selected treatment
  • Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan

Kazan', Tatarstan Republic, 420012, Russia

Location

Study Officials

  • Dmitry Petrunin, MD PhD

    Leo Pharmaceutical Products LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

June 11, 2018

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

March 16, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)