Scleroderma Clinical Trial
Official title:
Efficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon
Verified date | August 2014 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. The investigators' study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.
Status | Completed |
Enrollment | 17 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - diagnosis of scleroderma - definite Raynaud's Exclusion Criteria: - symptomatic orthostatic hypotension - evidence of current malignancy - active ischemic digital ulcer and/or tissue gangrene - history of sympathectomy at any time - upper extremity deep vein thrombosis or lymphedema within 3 months of the study - recent surgical procedure requiring general anesthesia - current alcohol or illicit drug use - use of any investigational drug within 30 days of the study sessions - pregnancy or current breast feeding - subjects felt by the investigators to active disease that would affect their ability to safely participate in the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Time to Recover 50% of Fall in the Baseline Skin Temperature. | The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers. | within 60 minutes | No |
Primary | Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge. | The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers. | within 60 minutes | No |
Secondary | The Blood Flow by Laser Doppler Scans of the Fingers | The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study. | Blood flow prior to cold challenge 2 hours after taking study drug | No |
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