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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 98

Inclusion Criteria

·Patients male and female =18 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. Patients will also be eligible for treatment if, despite a history of systemic sclerosis longer than three years from the onset of cutaneous manifestations, they have active skin disease, defined as a worsening of the Modified Rodnan Skin Score (MRSS) during the last year of follow-up or by the clinical judgement of its attending physician.
·Symmetric lesions in forearms. The extension of the selected symmetric lesions must be at least 15 square cm.
·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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
·PUVA therapy within 1 month of study drug initiation.
·Concurrent interventional therapy that might independently influence outcome of trial, such as D-penicillamine, cyclosporine, interferon-g or photopheresis.
·Topical corticosteroids treatment affecting the selected area.
·Cosmetics over the treatment area.
·Pregnant or breast-feeding women.
·Reasonable expectation that the subject will not be able to satisfactorily complete the study:
oHistory of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
oHistory of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements.
oReceipt of any investigational drug within three months of screening visit.
oDocumented noncompliance.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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