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Dermatologic

Morphea Clinical Trials and Treatments

Also called Localized Scleroderma, Circumscribed Scleroderma

Morphea is a localized form of scleroderma centered on the skin and the tissue beneath it, which in deep and linear forms can extend to fascia, muscle and bone, without the systemic manifestations characteristic of systemic sclerosis (systemic sclerosis primarily affects internal organs). The pathophysiology involves excessive collagen deposition in the dermis and subcutaneous tissues, mediated by transforming growth factor-beta (TGF-β) and other fibrogenic cytokines, with activation of fibroblasts and myofibroblasts.

In plain words, morphea is a skin condition where patches of skin become hard and thick and may turn lighter or darker. It does not spread to organs like the heart or lungs, though deeper patches can reach muscle and limit movement near a joint.

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Morphea

Where treatments stand, from ClinicalTrials.gov and FDA labels

Also 4 studies with no phase, like observational studies.

FDA review0

No decision pending. FDA calendar

FDA-approved medicines0

No medicine's current FDA label names Morphea yet.

Morphea has no FDA-approved medicines, 4 open or active clinical trials (4 recruiting), and no pending FDA decision.

Labels checked October 21, 2026.Download the data

More about Morphea

Morphea presents as circumscribed patches of induration with characteristic lilac ring (reddish-purple border) in early stages. Lesions typically begin as erythematous or violet patches that gradually harden and become sclerotic. Hypopigmentation or hyperpigmentation develops at lesion sites. Common locations include lower abdomen, flanks, upper back, and lower extremities.

Keep reading about Morphea

Morphea can be superficial (affecting dermis only) or involve subcutaneous tissue and muscle. Linear morphea, including the en coup de sabre form on the forehead and scalp, can cause significant deformity, particularly when involving the face or affecting function over joints. En coup de sabre with facial involvement can cause hemifacial atrophy. Internal organ involvement, which defines systemic sclerosis, does not occur with morphea, though a minority of people, especially children, have joint pain or fatigue.

What are the symptoms of Morphea?

These are common symptoms of Morphea, and how strong they are varies from person to person.

  • Hardened, thickened patches of skin with well-defined borders
  • Purple or reddish rings around patches (lilac ring sign)
  • Hypopigmentation or hyperpigmentation of affected areas
  • Skin tightness and loss of normal skin texture
  • Itching or burning sensations
  • Contractures and functional impairment if involving joints

Who gets Morphea?

Morphea can develop at any age but has 2 peaks, one in children aged 2 to 14 and one in adults in their 40s, and is about 4 times more common in women than men. It occurs across all racial and ethnic groups, though some studies suggest higher prevalence in Caucasians. The disease is not inherited, though autoimmune tendency may run in families.

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Side effects people have reported to the FDA

Side effects people have reported to the FDA

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and genetic testing

Genetic testing for Morphea

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Morphea resources

Reputable organizations and medical references for learning more about Morphea, including disease registries, foundation resources, and clinical guidelines.

Active clinical trials for Morphea

Use this Morphea clinical trial finder to see the 4 studies recruiting patients in the United States and worldwide, with eligibility criteria in plain English. Of these, 1 tests a treatment and 3 are observational studies or registries; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline timeline.

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

4 active trials worldwide
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RecruitingObservational study, no treatment givenNo updates in a whileNCT01808937

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

Intervention: Morphea

Sponsor: University of Texas Southwestern Medical Center

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

Ages up to 90 Years1 location
Started May 2007Updated 6 months agoEst. Jan 2027 (~2 months)
RecruitingTreatment trialNo updates in a whileNCT07292961

Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma

Intervention: Cognitive Exercise Therapy Approach, Control group

Sponsor: Hacettepe University

This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.

Ages 7 Years+1 location
Started Dec 2025Updated 11 months agoEst. Dec 2027 (~1 year)
RecruitingObservational study, no treatment givenHasn't posted an update in over a yearNCT07182981

Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance

Intervention: Questionnaire application for child and adult scleroderma patients

Sponsor: Hacettepe University

It is recommended to focus on the physical functionality, chewing, and swallowing performance of individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial basis to su...

Ages 7 Years+1 location
Started Aug 2025Updated 1 year agoEst. Aug 2027 (~9 months)
RecruitingObservational study, no treatment givenHasn't posted an update in over a yearNCT07183072

Patients Diagnosed With Scleroderma: Physical Performance and Functionality

Intervention: Questionnaire and functionality application for child and adult scleroderma patients

Sponsor: Hacettepe University

Physical functionality and performance are important for individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial basis to support their disease management. In light...

Ages 7 Years+1 location
Started Aug 2025Updated 1 year agoEst. Aug 2027 (~9 months)
Find Morphea trials near you, ranked by distance →
Active trial locations1 city in the US
A study site. Select it to see its trials and get directions. Several sites close together. Select the number to zoom in.

Trial Pipeline

Jan 2021 to Jan 2028
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Observational
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RecruitingNot yet recruitingDelayed startTodayHover a bar for trial details

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Morphea patient communities

Facebook groups, Reddit communities and YouTube channels where Morphea patients, caregivers and advocacy groups talk.

Companies developing Morphea treatments

Drugmakers that list Morphea in their rare disease portfolio, 1 in all.

Questions people ask about Morphea