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

Recruiting

• Conditions: Morphea; Frontal Linear Scleroderma en Coup de Sabre; Scleroderma, Linear; Scleroderma, Localized; Scleroderma, Circumscribed
• Interventions: Other: Morphea

• Registration Number: NCT01808937
• Lead Sponsor: University of Texas Southwestern Medical Center

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life scores measured by the Dermatology Life Quality Index (DLQI)	5 years

Trial Locations

Locations (1)

UT Southwestern Medical Center - Department of Dermatology; 🇺🇸 Dallas, Texas, United States