Scleroderma, LocalizedMACNCT01808937
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
An observational study of Scleroderma, Localized and Morphea, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically: How morphea behaves over time How frequently specific problems occur along with… Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Scleroderma, Localized, Morphea, Frontal Linear Scleroderma en Coup de Sabre
- What is being tested?
- Morphea
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2028
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Recruitment from clinic visits as well as from regional and national referrals.
Who may be able to join
- Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
- Ages 0-90 years old
- Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
- Patient or legal guardian must be able to speak and read at a 6th grade reading level.
- Both male and female patients will be eligible
- All races and ethnic backgrounds will be included
- Relationships to proband: All patients with morphea will be included. A patient's family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator's contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so.
- Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.
Who cannot join
- Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center - Department of Dermatology
Dallas, Texas, 75390-9069
Heidi Jacobe, MD, MSCS, 214.633.1837, heidi.jacobe@utsouthwestern.edu
Heidi Jacobe, MD, MSCS
About this study
Official title: Immunologic and Genetic Profiles in Subsets of Morphea Patients
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically:
- How morphea behaves over time
- How frequently specific problems occur along with morphea (for example, arthritis)
- Whether morphea has an autoimmune background
- Conditions
- Scleroderma, Localized, Morphea, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Circumscribed, Scleroderma, Linear
- Being tested
- Morphea
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorpheaOther
Also called Scleroderma, Localized, Scleroderma, Circumscribed, Scleroderma, Linear, Frontal Linear Scleroderma en Coup de Sabre
| Study group | Role | What they receive |
|---|---|---|
| Morphea | Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre) Receives: Other: Morphea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Measured: 5 years
Secondary outcomes (1)
Quality of life scores measured by the Dermatology Life Quality Index (DLQI)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMay 2007
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, LocalizedStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Jacobe, University of Texas Southwestern Medical Center
- Investigators
- Heidi Jacobe, MD, MSCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808937
- Sponsor's protocol ID
- 032007021; STU 112010-028
- Acronym
- MAC
- Status last verified
- May 2026
- First submitted
- 25 Feb 2013
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic and Genetic Profiles in Subsets of Morphea Patients
- ClinicalTrials.gov ID
- NCT01808937
- Acronym / sponsor ID
- MAC / 032007021; STU 112010-028
- Conditions
- Scleroderma, Localized, Morphea, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Circumscribed, Scleroderma, Linear
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 11 Mar 2013 (estimated)
- 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.
The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically:
- How morphea behaves over time
- How frequently specific problems occur along with morphea (for example, arthritis)
- Whether morphea has an autoimmune background
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphea | – | Other: MorpheaThose having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre) |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recruitment from clinic visits as well as from regional and national referrals.
Key inclusion criteria (8 listed)
- Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
- Ages 0-90 years old
- Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
- Patient or legal guardian must be able to speak and read at a 6th grade reading level.
- Both male and female patients will be eligible
Key exclusion criteria (1 listed)
- Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorpheaAlso: Scleroderma, Localized, Scleroderma, Circumscribed, Scleroderma, Linear, Frontal Linear Scleroderma en Coup de Sabre | Other | Morphea |
Primary outcome
Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Time frame: 5 years
1 secondary outcome
Quality of life scores measured by the Dermatology Life Quality Index (DLQI)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- UTSW Morphea Registry HomepageLink provided by the sponsor.
Related trials for Scleroderma, Localized
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
Scleroderma
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
Enrolling by invitationObservational study
Elastography Ultrasound in Localized Scleroderma (Morphea) Study
Scleroderma
Active, not recruiting
Brain Boost Program to Improve Cognitive Function in People With Systemic Sclerosis
Scleroderma
Recruiting
Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma
Scleroderma, Scleroderma, Localized
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.
Heidi Jacobe, MD, MSCS principal investigator
University of Texas Southwestern Medical Center
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 Scleroderma, Localized and Morphea, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Jacobe, MD, MSCS (214.633.1837, heidi.jacobe@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) (time frame: 5 years). 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 12 May 2026.