Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00781053 |
Recruitment Status :
Completed
First Posted : October 28, 2008
Last Update Posted : February 11, 2013
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Condition or disease | Intervention/treatment | Phase |
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Skin Fibrosis | Drug: P144 cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study With P144 Topical Adminsitration for Skin Fibrosis in Patients With Systemic Sclerosis |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: P144 cream
P144 cream 0.03% will be used once a day during the whole extension period of 6 months.
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Drug: P144 cream
P144 cream 0.03% will be used once a day during the whole extension period of 6 months. The patient will apply the cream by him/herself or with a help of a person uniformly in a 10% maximum affected surface until absorption |
- Assess the long-term safety of digna P144 cream topically administered in skin manifestations of systemic sclerosis patients. [ Time Frame: 6 months ]
- Quality o life assessment, skin induration and hardness. In a subgroup of patients pharmacokinetic and elasticity will be measured. [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous participation and finalization of treatment period of the ISD002-P144-07 study without clinical relevant safety issues medically evaluated by the investigator.
- 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.
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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.
- 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
Exclusion Criteria:
- Other skin diseases affecting the treatment area which could have been diagnosed during the ISD002-P144-07 study.
- Woman became pregnant during the ISD002-P144-07 study.
- 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.
- 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-γ or photopheresis; topical corticosteroids treatment affecting the selected area; cosmetics over the treatment area.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781053

Study Chair: | Marco Matucci, MD, PhD | University of Florence |
Responsible Party: | ISDIN |
ClinicalTrials.gov Identifier: | NCT00781053 |
Other Study ID Numbers: |
ISD003-P144-08 2008-001265-28 |
First Posted: | October 28, 2008 Key Record Dates |
Last Update Posted: | February 11, 2013 |
Last Verified: | February 2013 |
skin fibrosis systemic scleroderma systemic sclerosis p144 orphan drug |
Fibrosis Pathologic Processes |