Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository (MAC)
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ClinicalTrials.gov Identifier: NCT01808937 |
Recruitment Status :
Recruiting
First Posted : March 11, 2013
Last Update Posted : February 28, 2023
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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
Condition or disease | Intervention/treatment |
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Scleroderma, Localized Morphea Frontal Linear Scleroderma en Coup de Sabre Scleroderma, Circumscribed Scleroderma, Linear | Other: Morphea |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 6 Years |
Official Title: | Immunologic and Genetic Profiles in Subsets of Morphea Patients |
Actual Study Start Date : | May 2007 |
Estimated Primary Completion Date : | January 2027 |
Estimated Study Completion Date : | January 2028 |

Group/Cohort | Intervention/treatment |
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Morphea
Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre)
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Other: Morphea
Other Names:
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- Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) [ Time Frame: 5 years ]
- Quality of life scores measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 90 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808937
Contact: Heidi Jacobe, MD, MSCS | 214.633.1837 | heidi.jacobe@utsouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center - Department of Dermatology | Recruiting |
Dallas, Texas, United States, 75390-9069 | |
Contact: Heidi Jacobe, MD, MSCS 214-633-1837 heidi.jacobe@utsouthwestern.edu | |
Principal Investigator: Heidi Jacobe, MD, MSCS |
Principal Investigator: | Heidi Jacobe, MD, MSCS | University of Texas Southwestern Medical Center |
Responsible Party: | Heidi Jacobe, PROFESSOR, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT01808937 |
Other Study ID Numbers: |
032007021 |
First Posted: | March 11, 2013 Key Record Dates |
Last Update Posted: | February 28, 2023 |
Last Verified: | February 2023 |
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Connective Tissue Diseases Skin Diseases |