Registry for adults and children with morphea
Immunologic and Genetic Profiles in Subsets of Morphea Patients
This study is tracking how morphea affects both adults and children over time to learn more about the condition and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | N/A to 90 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT01808937 on ClinicalTrials.gov |
What this trial studies
The Morphea in Adults and Children (MAC) cohort is the first registry dedicated to understanding morphea, a form of localized scleroderma, in both adults and children. This observational study aims to track the progression of morphea over time, identify associated complications such as arthritis, and explore the potential autoimmune nature of the condition. Participants will be monitored to gather valuable data that can enhance understanding and treatment of morphea. The study includes patients aged 0 to 90 years with a confirmed diagnosis of morphea.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 0-90 years with a clinical diagnosis of morphea confirmed by a primary investigator.
Not a fit: Patients without a confirmed diagnosis of morphea or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved understanding and management of morphea, ultimately enhancing patient care.
How similar studies have performed: While this registry approach is relatively novel for morphea, similar registries for other autoimmune conditions have shown success in advancing understanding and treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination. 2. Ages 0-90 years old 3. 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. 4. Patient or legal guardian must be able to speak and read at a 6th grade reading level. 5. Both male and female patients will be eligible 6. All races and ethnic backgrounds will be included 7. 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. 8. 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)
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center - Department of Dermatology — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Heidi Jacobe, MD, MSCS — University of Texas Southwestern Medical Center
- Study coordinator: Heidi Jacobe, MD, MSCS
- Email: heidi.jacobe@utsouthwestern.edu
- Phone: 214.633.1837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.