Clinical Trial: Doxycycline Treatment in Mild Graves' Orbitopathy
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Effect of Subantimicrobial Dose Doxycycline in Mild Graves' Orbitopathy
Brief Summary: The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).
Detailed Summary:
Graves'orbitopathy is an autoimmune disease that can be treated by corticosteroids and surgery. But they often cause severe side-effects and are usually used for treating moderate-sever and sight-threatening GO. Wait and see will be the first choice for the patient with mild GO.
Subantimicrobial dose (SD) doxycycline displays a strong anti-inflammatory and immunomodulatory function, which is independent of its antibiotic properties. Data from clinical trials demonstrated that SD doxycycline was effective in moderating inflammation in a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea and periodontitis.
We propose to test the effect of subantimicrobial dose doxycycline for mild GO.
Sponsor: Sun Yat-sen University
Current Primary Outcome: Treatment response [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ocular surface disease index (OSDI) [ Time Frame: 12 weeks ]
- Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 12 weeks ]
- Health related quality of life questionnaires (GO-QoL) [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Sun Yat-sen University
Dates:
Date Received: July 28, 2014
Date Started: July 2014
Date Completion: July 2015
Last Updated: July 28, 2014
Last Verified: July 2014