Body PSOriasis: Long-term Relapse CONTROL | NCT03402828

Studies
Body PSOriasis: Long-term Relapse CONTROL

NCT03402828

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Mar 16, 2021Actual

Enrollment

764Actual

Phase

Not provided

Conditions

Psoriasis Vulgaris

Interventions

Any topical drug treatment

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2018Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

May 15, 2020Actual

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 11, 2018

First Posted Date

Jan 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

764Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Any topical drug treatment	Drug	Any treatment strategy used to prevent relapse of psoriasis symptoms		Non-drug topicals

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time of relapse	Length of relapse free period after start of maintenance strategy	Up to 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Dermatology Life Quality Index	Standard QoL measure within dermatology	Up to 52 weeks
PGA (physician's global assessment of symptoms)	5-point verbal rating scale

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with psoriasis vulgaris attending one of the participating outpatient dermatology clinics entering a phase of prevention of relapse of psoriasis symptoms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dmitry Petrunin, MD PhD	Leo Pharmaceutical Products LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan		Kazan'	Tatarstan Republic	420012	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided