Data di Pubblicazione:
2019
Citazione:
Effects of Polydeoxyribonucleotide in the treatment of Scleroderma / S. Recalcati, C. Moltrasio, G. Nazzaro, E. Passoni, J. Gliozzo, S. Muratori, E. Berti. ((Intervento presentato al 24. convegno World Congress of Dermatology (WCD) tenutosi a Milano nel 2019.
Abstract:
Introduction: Morphea, also known as localized scleroderma, is a chronic autoimmune
disorder characterized by skin thickening with an increased deposition of collagen in the
lesional site.
Different therapeutic approaches are proposed, but most of them are poorly effective.
Polydeoxyribonucleotide (PDRN) is a drug used for healing of cutaneous wounds. It is
known to selectively act on the A2 purinergic receptor to help cell growth and it seems to
interfere with several patho-physiological pathways involved in the fibrotic and atrophic skin.
Objective: Aim of this study is to evaluate the efficacy and safety of PDRN in patients with
fibrotic and atrophic cutaneous lesions in scleroderma disease.
Materials and Methods: This study is a single center open-label clinical trial with 45 subjects
expected. So far 25 patients were enrolled at Policlinico Hospital of Milan. PDRN is
administered intramuscularly for 3 months, followed by 3 months of follow up. Primary
endpoint for determining efficacy and safety is the clinical improvement determined through
LOSCAT Score.
Secondary endpoints are changes in tele-thermographic and ultrasound profile of a selected
target cutaneous lesion after PDRN treatment. Moreover, measurement of histology
improvement of lesional site after drug administration (especially new vessels formation)
and evaluation of patient’s satisfaction, through a self-administered Dermatology Life
Quality Index, are considered.
The exploratory endpoint is the change in degree of induration of subcutaneous tissue at the
level of scleroderma lesion through a new device called SkinFibrometer.
All variables will be summarized using appropriate descriptive statistics.
Results: PDRN therapy was found to significantly modify the degree of induration at the
scleroderma lesions and to improve the patient’s quality of life. No side effects were found.
Conclusions: Our trial, although preliminary, suggest that PDRN can improve the clinical
outcome of patients affected by localized scleroderma, with a good safety profile.
Tipologia IRIS:
14 - Intervento a convegno non pubblicato
Elenco autori:
S. Recalcati, C. Moltrasio, G. Nazzaro, E. Passoni, J. Gliozzo, S. Muratori, E. Berti
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