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Localized scleroderma is the skin localized form of scleroderma characterized by fibrosis of the skin causing cutaneous plaques or strips.
Biomarker and diagnostic research for localized scleroderma has been reported in the published literature.
No approved treatments are currently available for localized scleroderma. An additional 2 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for localized scleroderma, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for localized scleroderma. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: 1-9 in 100,000 (Uncommon).
7 clinical trials registered, 4 recruiting. Interventions under study include other interventions, medical devices, and procedural interventions. Pipeline includes 3 NA. Research is primarily sponsored by academic and government institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT01808937](https://clinicaltrials.gov/study/NCT01808937) |
Data assembled from 5 of 12 sources · Last updated Sep 18, 2026, 10:03 PM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Designated
Exclusivity End |
|---|
Designation Status |
|---|
HDF-LV-RTS-MMP1 (human dermal fibroblasts genetically modified with LV-RTS-MMP1) and Veledimex | HDF-LV-RTS-MMP1 (human dermal fibroblasts genetically modified with LV-RTS-MMP1) and Veledimex | Castle Creek Biosciences, LLC | 2016 | — | Withdrawn |
Peptide 144 TGF beta-1-inhibitor | Peptide 144 TGF beta-1-inhibitor | Digna Biotech, S.L. | 2006 | — | Designated |
Gene therapy approaches for localized scleroderma have been reported in the published literature.
7 trials found
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
— |
University of Texas Southwestern Medical Center |
RECRUITING |
[NCT04922736](https://clinicaltrials.gov/study/NCT04922736) | Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases | NA | University of Utah | ACTIVE_NOT_RECRUITING |
[NCT07292961](https://clinicaltrials.gov/study/NCT07292961) | Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma | NA | Hacettepe University | RECRUITING |
[NCT06847750](https://clinicaltrials.gov/study/NCT06847750) | Elastography Ultrasound in Localized Scleroderma (Morphea) Study | — | The Hospital for Sick Children | ENROLLING_BY_INVITATION |
[NCT06646146](https://clinicaltrials.gov/study/NCT06646146) | Study on the Efficacy of Autologous Fat Grafting in Improving Hair Transplantation Outcomes for Patients With Localized Scleroderma-Related Alopecia | NA | Nanfang Hospital, Southern Medical University | NOT_YET_RECRUITING |
203 publications have been identified in PubMed for localized scleroderma. Kisho has analyzed 156 by research type. Research spans Case Report / Case Series (31%), Review / Meta-Analysis (24%), and Basic Science / Preclinical (10%).
Research Type | Count | % of Total |
|---|---|---|
Patient case studies | 48 | 31% |
Research summaries | 37 | 24% |
Laboratory research | 16 | 10% |
Disease patterns and progression | 15 | 10% |
Other research | 14 | 9% |
Testing and diagnosis research | 10 | 6% |
Clinical study results | 10 | 6% |
New treatment approaches | 6 | 4% |
Traini DO (2026). [PMID: 41379523](https://pubmed.ncbi.nlm.nih.gov/41379523/). *Ital J Dermatol Venerol*. [Case Report / Case Series]
Alkurdi D (2026). [PMID: 41209845](https://pubmed.ncbi.nlm.nih.gov/41209845/). *JID Innov*. [Clinical Trial Publication]
Su Y (2026). [PMID: 41619232](https://pubmed.ncbi.nlm.nih.gov/41619232/). *J Eur Acad Dermatol Venereol*. [Other]
Elbatawy A (2026). [PMID: 41739593](https://pubmed.ncbi.nlm.nih.gov/41739593/). *Plast Reconstr Surg*. [Epidemiology / Natural History]
Abo Kharma M (2026). [PMID: 42124900](https://pubmed.ncbi.nlm.nih.gov/42124900/). *Case Rep Oncol*. [Case Report / Case Series]
Wregg JF (2026). [PMID: 42183824](https://pubmed.ncbi.nlm.nih.gov/42183824/). *Exp Dermatol*. [Clinical Trial Publication]
Tsai WH (2026). [PMID: 42027856](https://pubmed.ncbi.nlm.nih.gov/42027856/). *JAAD Case Rep*. [Epidemiology / Natural History]
Zhang X (2026). [PMID: 41949609](https://pubmed.ncbi.nlm.nih.gov/41949609/). *Pediatr Radiol*. [Gene Therapy / Novel Therapeutics]
Jensen C (2026). [PMID: 42005244](https://pubmed.ncbi.nlm.nih.gov/42005244/). *Cureus*. [Case Report / Case Series]
Barnawi G (2026). [PMID: 41527862](https://pubmed.ncbi.nlm.nih.gov/41527862/). *J Cutan Med Surg*. [Other]
AI-curated news mentioning localized scleroderma
Updated Sep 7, 2026
A recent study highlights the complexities of managing scleroderma renal crisis and associated cardiac complications in a young patient with mixed connective tissue disease (MCTD). The case emphasizes the need for further research into the implications of anti-U3 RNP and anti-RNA polymerase III antibodies.
Recent research highlights the occurrence of scleroderma renal crisis in patients with mixed connective tissue disease, providing new insights into this rare complication. Understanding this association may improve clinical management and patient outcomes.
A new study highlights the cellular and molecular dysregulation of the esophageal epithelium in systemic sclerosis. This research provides insights into the pathophysiology of the disease, which may inform future therapeutic strategies.