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Sponsors and Collaborators: |
ISDIN DigNA Biotech |
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Information provided by: | ISDIN |
ClinicalTrials.gov Identifier: | NCT00781053 |
Transforming growth factor-beta 1 is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts(25, 26). Activation of TGF-beta receptors induces the activation of several kinase signalling cascades leading to the phosphorylation of SMAD proteins as well as to the activation of SMAD-independent kinases that collectively activate ECM synthesis and fibroblast growth and differentiation into myofibroblasts. TGF-beta 1 i one of the main mediators in the fibrotic process, associated to both scarring and a long list of pathologies related to chronic inflammation and which affect all type of organs and tissues. An increase in TGF-beta1 mRNA and protein levels has been described in these processes. Peptide 144 (P144)is a acetic salt of a 14mer peptide from human TGF-beta1 type III receptor (betaglycan). P144 TGF-beta1-inhibitor has been specifically designed to block the interaction between TGF-beta1 and TGF-beta1 type III receptor, thus blocking its biological effects. P144 has shown significant antifibrotic activity in mice receiving repeated sucutaneous injections of bleomycin, a widely accepted animal model of human scleroderma, and could contribute to the development. The aim of the study is to asses the long-term safety of topical application of P144 cream in the treatment of skin fibrosis in patients with systemic sclerosis in an extension open-label treatment period of 6 additional months.
Condition | Intervention | Phase |
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Skin Fibrosis |
Drug: P144 cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 98 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P144 cream: Experimental
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
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Systemic sclerosis or scleroderma is a multisystemic disorder characterized by the excessive synthesis and deposition of extracellular matrix proteins that result in the fibrosis of skin and visceral organs (including gastrointestinal tract, lungs, heart and kidneys).The pathogenesis of scleroderma is complex and still poorly understood, but major pathways involved in the development of the condition are microvascular and immunological abnormalities, as well as dysregulation of fibroblast activity. One of the key molecules involved in the pathogenesis of skin fibrosis is the TGF-beta1; TGF-beta1 is a cytokine directly responsible for fibroblasts proliferation and collagen and extracellular matrix overproduction. The affected skin of patients with systemic sclerosis gradually becomes firm, thickened and eventually tightly bound to underlying subcutaneous tissue (indurative phase). It loses hair, oil, and sweat glands becoming dry and coarse. Changes begin distally in the extremities and advance proximally. Lesions develop over a period of time varying from months to a few years. In patients with limited scleroderma, only the skin of fingers, hands, face and lower arms and legs are affected. On the contrary, patients with the diffuse cutaneous disease, skin changes will become generalized, involving initially the extremities and followed by the face and trunk. Rapid progression of these changes over a 2 to 3 year period is usually associated with a greater risk of visceral disease. After several years of disease, the skin may soften and return to normal thickness or become thin and atrophic. The EMEA and FDA have granted P144 the orphan drug status for the treatment of systemic sclerosis. The primary objective is to assess the long-term safety of P144 crem topically administered in skin manifestations of systemic sclerosis patients in terms of the incidence of treatment related adverse events during the extension period of six months.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: Raul Insa, MD, PhD | 34932402020 ext 1134 | raul.insa@isdin.com |
Contact: Elena M Vernet, MD, PhD | 34932402020 ext 1134 | elena.vernet@isdin.com |
Germany | |
Herz- und Rheumazentrum Kerckhoff-Klinik | Not yet recruiting |
Bad Hauheim, Germany, 61231 | |
Contact: Ulf Müller-Ladner, PhD 06032 996 2101 u.mueller-ladner@kerxhhoff-klinik.de | |
Contact: Tim Schmeiser, MD 06032 996 2101 t.schmeiser@kerckhoff-klinik.de | |
Principal Investigator: Ulf Müller-Ladner, Phd | |
Allergie-Centrum-Charité, Abteilung für | Not yet recruiting |
Berlin, Germany, 10117 | |
Contact: Margarita Worm, PhD 030-450 518 105 margitta.worm@charite.de | |
Contact: Claudia Rasche, MD 030-450 618 305 claudia.rasche@charite.de | |
Principal Investigator: Margitta Worm, PhD | |
Klinikum der Johan Wolfgang Goethe-Universitat | Not yet recruiting |
Frankfurt, Germany, 60590 | |
Contact: Frank Behrens, PhD 069 6301 6109 frank.behrens@kgu.de | |
Contact: Andrea Himsel, MD 069 6301 7312 andrea.himsel@kgu.de | |
Sub-Investigator: Andrea Himsel, MD | |
Klinik und Poliklinik für Dermatologie und Vererologie | Not yet recruiting |
Köln, Germany, 50937 | |
Contact: Thomas M Krieg, PhD 0221 478 4500 thomas.krieg@uni-koeln.de | |
Contact: Nicolas Hunzelmann, MD 0221 478 4517 nico.hunzelmann@koeln.de | |
Sub-Investigator: Nicolas Hunzelmann, PhD | |
Hungary | |
Immunologiai es Reumatologiai Klinika | Not yet recruiting |
Pécs, Hungary, H-7621 | |
Contact: Czirjak Laszlo, PhD 0036 72 507 300 ext 7311 laszlo.czirjak@aok.pte.hu | |
Contact: Kumanovics Gábor, MD 0036 72 507 300 ext 7122 gabor.kumanovics@aok.pte.hu | |
Principal Investigator: Czirjak Laszlo, PhD | |
Poland | |
Centrum Mirada | Not yet recruiting |
Bialystok, Poland, 15-297 | |
Contact: Stanislaw Sierakowski, PhD 48-85 746 84 82 stanislawsierakowski@hotmail.com | |
Contact: Elzbiela Muklewicz, MD 48-604937707 muckla@op.pl | |
Principal Investigator: Stanislaw Sierakowski, PhD | |
Samodzielny Publiczny Szpital Kliniczny | Not yet recruiting |
Katowice, Poland | |
Contact: Eugeniusz Kucharz, PhD 48-32 359 82 90 ekucharz@slam.katowice.pl | |
Contact: Anna Kotulska, MD 48-32 359 82 90 akotulska@poczta.onet.pl | |
Principal Investigator: Eugeniusz Kuchark, PhD | |
Katedra i Klinika Raumatologizno | Not yet recruiting |
Poznan, Poland, 61-545 | |
Contact: Mariusz Puszczewicz, PhD 48-603661016 pusczewicz@hotmail.com | |
Contact: Aleksandra Kolczewska, MD 48-603661016 kolczewska1@hotmail.com | |
Principal Investigator: Mariusz Puszczewicz, PhD | |
Gabinet Lekarski Internistyczno- Reumatologiezny | Not yet recruiting |
Wroclaw, Poland, 53-137 | |
Contact: Jacek Szechinski, PhD 48713602162 sekreum@reum.am.wroc.pl | |
Contact: piotr Wiland, MD 48713602162 pwiland@provider.pl | |
Principal Investigator: Jacek Szechinski, PhD | |
Klinika Ftizjopneumonologii SAM | Not yet recruiting |
Zabrze, Poland, 41-803 | |
Contact: Jerzy Kozielski, PhD 48- 32 27 56 64 jerzy.kozielski@neostrada.pl | |
Contact: Dariusz Jastrzebski, MD 48- 32 27 56 64 darekdr@poczta.onet.pl | |
Principal Investigator: Jerzy Kozielski, PhD | |
Spain | |
Hospital Clinic i Provincial de Barcelona | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Carmen Herrero, PhD 34 93 227 54 00 ext 2422 CHERRERO@clinic.ub.es | |
Principal Investigator: Carmen Herrerp, PhD | |
Hospital 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Contact: Jose L Pablos, MD 34 91 390 85 98 jpablos@h12o.es | |
Contact: Patricia Carreira, MD 34 91 390 85 98 carreira@h12o.es | |
Sub-Investigator: Patricia Carreira, MD, PhD | |
Clinica de Navarra | Recruiting |
Pamplona, Spain, 31008 | |
Contact: Pedro Redondo, MD, PhD 34 948 25 54 00 ext 4312 predondo@unav.es | |
Contact: Maider Pretel, MD,PhD 34 948 25 54 00 ext 4322 mpretel@unav.es | |
Principal Investigator: Pedro Redondo, Phd | |
United Kingdom | |
Chapel Allerton Hospital | Active, not recruiting |
Leeds, United Kingdom, NW3 2QG | |
Royal Free Hospital | Recruiting |
London, United Kingdom, Nw3 2QG | |
Contact: Christopher Denton, PhD 0207 830 2284 c.denton@medsch.ucl.ac.uk | |
Contact: Rachel Ochiel, Nurse 0207 317 7544 rachel.Ochiel@royalree.nhs.uk | |
Principal Investigator: Christopher Denton, PhD |
Study Chair: | Marco Matucci, MD, PhD | University of Florence |
Responsible Party: | ISDIN ( ISDIN ) |
Study ID Numbers: | ISD003-P144-08, 2008-001265-28 |
Study First Received: | October 24, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00781053 |
Health Authority: | United Kingdom: National Health Service; Spain: Ministry of Health and Consumption; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Ministry of Scientific Research and Information Technology |
skin fibrosis systemic scleroderma systemic sclerosis p144 orphan drug |
Skin Diseases Fibrosis Connective Tissue Diseases Sclerosis Scleroderma, Systemic |
Pathologic Processes |