Trials / Completed
CompletedNCT01727973
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy: a Prospective, Uncontrolled Pilot Study
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy (GO).
Detailed description
Graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done until the inflammatory phase has passed. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids are the first-choice immunosuppressive treatment, but they often cause severe side-effects. Subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis. We propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening, moderate-severe, inflammatory GO.
Conditions
- Graves Ophthalmopathy
- Graves Disease
- Eye Diseases
- Thyroid Diseases
- Endocrine System Diseases
- Eye Diseases, Hereditary
- Hyperthyroidism
- Autoimmune Diseases
- Immune System Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxycycline | Tab. Doxycycline 50 mg PO per day for 12 weeks |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2012-11-16
- Last updated
- 2013-12-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01727973. Inclusion in this directory is not an endorsement.