Trial reportArthritis research & therapy2015
Pirfenidone gel in patients with localized scleroderma: a phase II study.
Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03076320 (Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne), which is not on this map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne
Who cites it
21 citing papers in PubMed, 42 citations in OpenAlex.
- Decoding fibroblast activation: Transcriptional networks in hepatic stellate cells and across fibrotic organs (Review).International journal of molecular medicine · 2026Review
- Pirfenidone in Skin Fibrosis and Scarring: From Bench Insights to Clinical Data.Medical sciences (Basel, Switzerland) · 2025Review
- Inflammation-fibrosis interplay in inflammatory bowel disease: mechanisms, progression, and therapeutic strategies.Frontiers in pharmacology · 2025Review
- Pirfenidone use in fibrotic diseases: What do we know so far?Immunity, inflammation and disease · 2024Review
- Clinical, Histologic, and Transcriptomic Evaluation of Sequential Fat Grafting for Morphea: A Nonrandomized Controlled Trial.JAMA dermatology · 2024Article
- Unravelling morphoea aetiopathogenesis by next-generation sequencing of paired skin biopsies.Archives of dermatological research · 2023Article
- Use of a novel indentometer to evaluate skin stiffness in healthy and diseased human skin.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2023Article
- A Soft Skin Adhesive (SSA) Patch for Extended Release of Pirfenidone in Burn Wounds.Pharmaceutics · 2023Article
- Pirfenidone Protects from UVB-Induced Photodamage in Hairless Mice.Molecules (Basel, Switzerland) · 2023Article
- TGF-β1 mediates pathologic changes of secondary lymphedema by promoting fibrosis and inflammation.Clinical and translational medicine · 2022Article
- Novel Synthetic Polymer-Based 3D Contraction Assay: A Versatile Preclinical Research Platform for Fibrosis.ACS applied materials & interfaces · 2022Article
- New Antifibroblastic Medication in Dermatology: Could Nintedanib Treat Scarring?International journal of general medicine · 2022Article
- Kinase inhibition in autoimmunity and inflammation.Nature reviews. Drug discovery · 2021Review
- Dual Asymmetric Centrifugation Efficiently Produces a Poloxamer-Based Nanoemulsion Gel for Topical Delivery of Pirfenidone.AAPS PharmSciTech · 2020Article
- Overview of Juvenile localized scleroderma and its management.World journal of pediatrics : WJP · 2020Review
- Pirfenidone reduces subchondral bone loss and fibrosis after murine knee cartilage injury.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2018Article
- Morphea and Eosinophilic Fasciitis: An Update.American journal of clinical dermatology · 2017Review
- Article
- The 2016 Bowman Lecture Conjunctival curses: scarring conjunctivitis 30 years on.Eye (London, England) · 2017Review
- Anti-fibrotic action of pirfenidone in Dupuytren's disease-derived fibroblasts.BMC musculoskeletal disorders · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLocalized scleroderma is an inflammatory disease in its first stages and a fibrotic process in later stages, principally mediated by the transforming growth factor β. To date, there is no standard treatment. The objective of this study was to determine the effectiveness and safety of 8% pirfenidone gel in patients with localized scleroderma.
methodsThis was an open phase II clinical trial that included 12 patients. Treatment with pirfenidone was indicated, three times daily for 6 months. Patients were evaluated clinically with the modified Localized Scleroderma Skin Severity Index (mLoSSI), as well with a durometer and histologically using hematoxylin and eosin stain and Masson's trichrome stain.
resultsThe baseline mLoSSI average scores were 5.83 ± 4.80 vs. 0.83 ± 1.75 (P = 0.002) at 6 months. The initial durometer induration of the scleroderma plaques was 35.79 ± 9.10 vs. 32.47 ± 8.97 at 6 months (P = 0.05). We observed histopathological improvement with respect to epidermal atrophy, inflammation, dermal or adipose tissue fibrosis and annex atrophy from 12.25 ± 3.25 to 9.75 ± 4.35 (P = 0.032). The 8% pirfenidone gel application was well tolerated, and no side effects were detected.
conclusionsThis is the first study on the therapeutic use of pirfenidone gel in localized scleroderma. It acts on both the inflammatory and the fibrotic phases. Considering its effectiveness, good safety profile and the advantage of topical application, pirfenidone is a treatment option in this condition.
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