Clinical Trial: Doxycycline Treatment in Mild Graves' Orbitopathy

Study Status: Completed
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 ]

As definition of treatment response, we used four criteria: reduction of 2 mm or more in proptosis; improvement of ≥8 degrees in any direction of eye movements; reduction of 2 mm or more in eyelid aperture; improvement in grade of soft tissue swelling. A successful response was defined as an improvement in one or more criteria, in absence of deterioration of any criterion in that observed eye. Deterioration was defined as occurrence of DON, and/or worsening of soft tissue swelling. No success was defined if there was no change or the changes did not reach the success criteria.


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