Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE
- Conditions
- Skin fibrosis in patients with systemic sclerosis.Szisztémás szklerózisban szenvedo betegek.MedDRA version: 9.1Level: LLTClassification code 10039710Term: Scleroderma
- Registration Number
- EUCTR2008-001265-28-HU
- Lead Sponsor
- ISDI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 98
1.Previous participation and finalization of treatment period of the ISD002-P144-07 study without clinical relevant safety issues medically evaluated by the investigator.
2.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 the extension study period and one month after the end of the extension study.
3.For male subjects with partners of childbearing potential: use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the extension study period and one month after the end of the extension study.
4.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..
5.Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
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
1.Other skin diseases affecting the treatment area which could have been diagnosed during the ISD002-P144-07 study.
2.Woman became pregnant during the ISD002-P144-07 study.
3.Any new diagnosis since the ISD002-P144-07 study which includes: systemic sclerosis sine scleroderma, localized escleroderma, eosinophilic fascitis, or 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 as defined in the guidelines for clinical trials in systemic sclerosis; history of skin cancer; other skin diseases affecting the treatment area.
4.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 ? or photopheresis; topical corticosteroids treatment affecting the selected area; cosmetics over the treatment area.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of Digna P144 cream topically administered in skin fibrosis of systemic sclerosis patients. <br>;Secondary Objective: As secondary endpoints: quality of life assessment, skin induration, and hardness. <br>In a subgroup of patients pharmacokinetic and elasticity will be measured <br>;Primary end point(s): Long-term safety evaluation of Digna P144 cream.
- Secondary Outcome Measures
Name Time Method