NCT01808937

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2007Jan 2028

Study Start

First participant enrolled

May 1, 2007

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

19.7 years

First QC Date

February 25, 2013

Last Update Submit

March 27, 2025

Conditions

Scleroderma, LocalizedMorpheaFrontal Linear Scleroderma en Coup de SabreScleroderma, CircumscribedScleroderma, Linear

Outcome Measures

Primary Outcomes (1)

  • Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)

    5 years

Secondary Outcomes (1)

  • Quality of life scores measured by the Dermatology Life Quality Index (DLQI)

    5 years

Study Arms (1)

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

Interventions

MorpheaOTHER
Also known as: Scleroderma, Localized, Scleroderma, Circumscribed, Scleroderma, Linear, Frontal Linear Scleroderma en Coup de Sabre
Morphea

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
  • Ages 0-90 years old
  • 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.
  • Patient or legal guardian must be able to speak and read at a 6th grade reading level.
  • Both male and female patients will be eligible
  • All races and ethnic backgrounds will be included
  • 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.
  • 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.

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center - Department of Dermatology

Dallas, Texas, 75390-9069, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

serum, WBC, tissue

MeSH Terms

Conditions

Scleroderma, Localized

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Heidi Jacobe, MD, MSCS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Jacobe, MD, MSCS

CONTACT

214.633.1837heidi.jacobe@utsouthwestern.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 11, 2013

Study Start

May 1, 2007

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

US(1)