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Title: Pirfenidone gel in patients with localized scleroderma: a phase II study
Authors: Rodríguez Castellanos, Marco
Tlacuilo Parra, Alberto
Sánchez Enríquez, Sergio
Vélez Gómez, Ezequiel
Guevara Gutiérrez, Elizabeth
Keywords: pirfenidone gel
localized scleroderma
inflammatory disease
Issue Date: 2014
Publisher: BioMed Central
Citation: Rodríguez Castellanos M., Tlacuilo Parra A., Sánchez Enríquez S., Vélez Gómez E. y Guevara Gutiérrez E. (2014) Pirfenidone gel in patients with localized scleroderma: a phase II study. Arthritis Research & Therapy. Vol.16:510
Series/Report no.: Arthritis Research & Therapy;Vol.16:510
Abstract: Introduction: Localized 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. Methods: This 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. Results: The 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. Conclusions: This 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.
URI: 10.1186/s13075-014-0510-4
ISSN: 1478-6362
Appears in Collections:3209 Artículos

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