A randomized double blind, placebo-controlled clinical trial with oral n-acetylcysteine in systemic sclerosis patients and assessment of skin blood flow of the hands with laser Doppler perfusion imaging

Phase 1

Completed

• Conditions: microcirculation; systemic sclerosis; fingertip blood flow; Inflammatory and Immune System - Connective tissue diseases

• Registration Number: ACTRN12610000114044
• Lead Sponsor: Foundation for the support for research in the state of Sao Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Raynaud phenomenon secondary to systemic sclerosis with pain

Exclusion Criteria

smokers and diabetes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement finger blood flow by laser Doppler perfusion imaging[blood flow of the fingertips will be evaluated at 0, 1 minute, 4 minutes, 17 minutes, 20 minutes, 10 minutes and 27 minutes before and after cold stimulation at week 1 and at 0, 1 minutes, 4 minutes, 17 minutes, 20 minutes, 10 minutes and 27 minutes after cold stimulation before and after 4 weeks of treatment with n-acetylcysteine or placebo]

Secondary Outcome Measures

Name	Time	Method
improvement of pain and severity of Raynaud phenomenon by visual analogical scale[30 minutes after cold stimulus before and after 4 weeks of treatment with drug or placebo]