- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264728
Adult-onset Generalized Morphea (MORPHEA)
February 11, 2020 updated by: University Hospital, Strasbourg, France
Adult-onset Generalized Morphea : A Retrospective Multicenter Study
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cédric LENORMAND, MD
- Phone Number: 33 3 88 11 66 27
- Email: cedric.lenormand@chru-strasbourg.fr
Study Contact Backup
- Name: Antoine BRAUD, MD
- Phone Number: 33 3 88 11 66 27
- Email: antoine.braud@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de dermatologie - Hôpital Civil de Strasbourg
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Contact:
- Cédric LENORMAND, MD
- Phone Number: 33 3 88 11 66 27
- Email: cedric.lenormand@chru-strasbourg.fr
-
Contact:
- Antoine BRAUD, MD
- Phone Number: 33 3 88 11 66 27
- Email: antoine.braud@chru-strasbourg.fr
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Principal Investigator:
- Cédric LENORMAND, MD
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Sub-Investigator:
- Antoine BRAUD, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retrospective study of generalized morphea in adult patients consulted in dermatology departments
Time Frame: Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined
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Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Cédric LENORMAND, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2019
Primary Completion (ANTICIPATED)
April 1, 2020
Study Completion (ANTICIPATED)
April 1, 2020
Study Registration Dates
First Submitted
February 7, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (ACTUAL)
February 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7551
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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