Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT01808937

Conditions

Scleroderma, Localized

Morphea

Frontal Linear Scleroderma en Coup de Sabre

Scleroderma, Circumscribed

Scleroderma, Linear

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

Morphea

Study Details

Brief 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 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

Study ID

NCT01808937

Start date

May, 2007

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Morphea

Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre)

Interventions

Morphea

Primary outcome measure

  • Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

UT Southwestern Medical Center - Department of Dermatology

Recruiting

Dallas, Texas, United States, 75390-9069

Contacts

Principal Investigator:

Heidi Jacobe, MD, MSCS

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-12.