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 - OLE

• Conditions: Skin fibrosis in patients with systemic sclerosis; MedDRA version: 9.1Level: LLTClassification code 10039710Term: Scleroderma

• Registration Number: EUCTR2008-001265-28-GB
• Lead Sponsor: ISDI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

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 1 month
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

Exclusion Criteria

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