Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository (MAC)

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

Study Overview

• Status: Recruiting
• Conditions: Scleroderma, Localized; Morphea; Frontal Linear Scleroderma en Coup de Sabre; Scleroderma, Circumscribed; Scleroderma, Linear
• Intervention / Treatment: Other: Morphea

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Heidi Jacobe, MD, MSCS; Phone Number: 214.633.1837; Email: heidi.jacobe@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9069
      • Recruiting
      • UT Southwestern Medical Center - Department of Dermatology
      • Contact: Heidi Jacobe, MD, MSCS; Phone Number: 214-633-1837; Email: heidi.jacobe@utsouthwestern.edu
      • Principal Investigator: Heidi Jacobe, MD, MSCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Recruitment from clinic visits as well as from regional and national referrals.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Morphea; Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre)	Other: Morphea; Other Names: Scleroderma, Localized; Scleroderma, Circumscribed; Scleroderma, Linear; Frontal Linear Scleroderma en Coup de Sabre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life scores measured by the Dermatology Life Quality Index (DLQI)	5 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Heidi Jacobe, MD, MSCS, University of Texas Southwestern Medical Center

Publications and helpful links

Helpful Links

• UTSW Morphea Registry Homepage

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimated): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: 032007021