"FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA" "SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS" MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma
Conditions
Sponsors
ISDIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients male and female >18 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patients diagnosed of: o Systemic sclerosis sine scleroderma. o Localized scleroderma. o Eosinophilic 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: o History of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent. o History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements. o Receipt of any investigational drug within three months of screening visit. o Documented noncompliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to asses the efficacy of P144 topically administered in skin lesions of systemic sclerosis patients throw the measure of soluble collagen content and durometry over three months.;Secondary Objective: The secondary objectives are to evaluate the efficacy (measured by histology with immunohistochemical and molecular markers analyses), as well as the safety, quality of life and pharmacokinetics of P144 topically administered one a day for up to three months. ;Primary end point(s): Soluble collagen content and skin hardness. | — |
Countries
Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed