Adult-onset Generalized Morphea | NCT04264728

Studies
Adult-onset Generalized Morphea

NCT04264728

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Feb 13, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Generalized Morphea

Interventions

Not provided

Countries

France

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Feb 7, 2020

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 11, 2020Actual

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

Feb 11, 2020

Last Update Posted Date

Feb 13, 2020Actual

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 study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of generalized morphea in adult patients consulted in dermatology departments		Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of onset ≥ 18 years
Patients with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites)
Availability of good-quality clinical photographs
Patient who, after being informed, has not expressed his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion Criteria:

Patients with linear morphea who met criteria for generalized morphea
Patient's opposition to participate

Accepts Healthy Volunteers

Not provided

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

Adult patient with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cédric LENORMAND, MD	Contact	33 3 88 11 66 27		cedric.lenormand@chru-strasbourg.fr
Antoine BRAUD, MD	Contact	33 3 88 11 66 27		antoine.braud@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Cédric LENORMAND, MD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de dermatologie - Hôpital Civil de Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D012594	Scleroderma, Localized

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided