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. - ND
- Conditions
- Skin Fibrosis in patients with systemic sclerosisMedDRA version: 12.0Level: LLTClassification code 10039710Term: Scleroderma
- Registration Number
- EUCTR2007-002015-38-IT
- Lead Sponsor
- ISDIN S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 98
 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 cm2.
 Stable therapy for at least one month, except in the case of patients under treatment
with putative disease modifying agents (immunosupressants like cyclophosphamide, 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.
 For male subjects with partners of child bearing potential: use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the study period 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) yes
F.1.3.1 Number of subjects for this age range
 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) See appendix 1.
 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, methotrexate, interferon-y 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses the efficacy of P144 topically administered in skin fibrosis of systemic sclerosis patients measured as the soluble collagen content and durometry over three months.;Secondary Objective: to evaluate the safety, quality of life and pharmacokinetics of P144 topically administered one a day for up of three months;Primary end point(s): The percentage of reduction in the soluble collagen content and skin hardness after three months of treatment relative to baseline.
- Secondary Outcome Measures
Name Time Method