Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT00318175|
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : September 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Systemic Scleroderma Skin Fibrosis Hand Functionality||Drug: Bosentan (Tracleer)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF)|
|Study Start Date :||June 2006|
|Study Completion Date :||May 2007|
- Measurable reduction of skin thickening using 20 MHz-ultrasound and the Rodnan Skin Score after treatment with study medication over 24 weeks in patients with systemic sclerosis.
- Effect of bosentan on hand functionality measured by SHAQ, UK-functional score, and fist closure as well as on nitrosylated serum protein levels in the plasma of patients with systemic scleroderma.
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): NCT00318175
|Heinrich-Heine-University of Duesseldorf, Department of Dermatology|
|Duesseldorf, NRW, Germany, 40225|
|Principal Investigator:||Annegret Kuhn, MD||Heinrich-Heine-University of Duesseldorf, Department of Dermatology|