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

Morphea Clinical Trial

— MAC  

Official title:

Immunologic and Genetic Profiles in Subsets of Morphea Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01808937
• Other study ID #: 032007021
• Status: Recruiting
• Start date: May 2007
• Est. completion date: January 2028

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Heidi Jacobe, MD, MSCS
• Phone: 214.633.1837
• Email: heidi.jacobe[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 morphea (for example, arthritis)

• Whether morphea has an autoimmune background

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Frontal Linear Scleroderma en Coup de Sabre
• Morphea
• Scleroderma, Circumscribed
• Scleroderma, Diffuse
• Scleroderma, Linear
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Other:
• Morphea

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center - Department of Dermatology	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)		5 years
Secondary	Quality of life scores measured by the Dermatology Life Quality Index (DLQI)		5 years

External Links

•   UTSW Morphea Registry Homepage