Generalized MorpheaMORPHEANCT04264728
Adult-onset Generalized Morphea
An observational study of Generalized Morphea, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Morphea
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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)
Who may be able to join
- 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
Who cannot join
- Patients with linear morphea who met criteria for generalized morphea
- Patient's opposition to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de dermatologie - Hôpital Civil de Strasbourg
Strasbourg, 67091
Cédric LENORMAND, MD, 33 3 88 11 66 27, cedric.lenormand@chru-strasbourg.fr
Antoine BRAUD, MD, 33 3 88 11 66 27, antoine.braud@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Generalized Morphea
- Keywords
- Morphea, Generalized Morphea, Localized Scleroderma
- Medical subject headings
- Scleroderma, Localized
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of generalized morphea in adult patients consulted in dermatology departments
Measured: Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Dec 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized MorpheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric LENORMAND, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264728
- Sponsor's protocol ID
- 7551
- Acronym
- MORPHEA
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult-onset Generalized Morphea : A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04264728
- Acronym / sponsor ID
- MORPHEA / 7551
- Conditions
- Generalized Morphea
- Keywords
- Morphea, Generalized Morphea, Localized Scleroderma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with linear morphea who met criteria for generalized morphea
- Patient's opposition to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric LENORMAND, MD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Morphea, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric LENORMAND, MD (33 3 88 11 66 27, cedric.lenormand@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.