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RecruitingNCT01808937MACUpdated May 12, 2026

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

An observational study in Scleroderma, Localized, Morphea and Frontal Linear Scleroderma en Coup de Sabre, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged Up to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of Texas Southwestern Medical Center · Observational

From the registry’s dates

  • Started May 2007; still recruiting 19 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
Up to 90 Years
Sex
All
01

Study 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
02

Conditions studied

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

Browse trials for

03

In context

Scleroderma, Localized

27 studies on the registry are indexed under Scleroderma, Localized; 4 are open to participants now.

Browse Scleroderma, Localized studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 : 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

Exclusion Criteria:

- Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
6 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherMorphea

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

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2007 (actual). Primary completion is estimated for Jan 2027, 236 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2013
First posted
Mar 11, 2013
StartActual
May 2007
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2028
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01808937
Responsible party
Heidi Jacobe (PROFESSOR, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 11, 2013
Start date
May 2007
Primary completion
Jan 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
May 12, 2026

Study contacts

Heidi Jacobe, MD, MSCS
Contact
heidi.jacobe@utsouthwestern.edu
214.633.1837
Heidi Jacobe, MD, MSCS
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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