Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.

ISDI0 sites98 target enrollmentJuly 9, 2007

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ISDI

•·Patients male and female \>18 \< 65 years at time of consent.
•·History of Systemic sclerosis (including diffuse scleroderma and limited scleroderma) for less than three years of evolution from the onset of cutaneous manifestations.
•·Symmetric lesions in forearms. The extension of the selected symmetric lesions must be at least 15 cm2\.
•·Stable therapy for at least one month, except in the case of patients under treatment with putative disease modifying agents (immunosupressants like cyclophosphamide, methotrexate or azathioprine) that will need at least three months of stable therapy, without the expectation of treatment modifications during the trial period.
•·Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
•·For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least three consecutive months prior to the study, during the study and one month after the end of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•·Patients diagnosed of:
•oSystemic sclerosis sine scleroderma.
•oLocalized scleroderma.
•oEosinophilic fascitis, eosinophilia myalgia syndrome.
•·Any other definable connective tissue disease, such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, or dermatomyositis.
•·Clinically significant overlap condition.
•·Significant existing internal organ damage (Kidney, Cardiovascular disease, Pulmonary disease, Gastrointestinal disease) as defined in Guidelines for clinical trial in systemic sclerosis (scleroderma)
•·History of skin cancer.
•·Other skin diseases affecting the treatment area.
•·Patients with substantial history of environmental exposure to tainted rapeseed oil, vinyl chloride, L\- tryptophan, bleomycin, trichoroethylene, or silica.