NCT02203682

Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy

The Effect of Subantimicrobial Dose Doxycycline in Mild Thyroid-Associated Ophthalmopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 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 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).

Detailed description

Thyroid-Associated Ophthalmopathy 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 TAO. Wait and see will be the first choice for the patient with mild TAO. 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 TAO.

Conditions

• Graves Ophthalmopathy
• Graves Disease
• Thyroid-associated Ophthalmopathy
• Thyroid Diseases
• Endocrine System Diseases
• Eye Diseases, Hereditary
• Hyperthyroidism
• Autoimmune Diseases
• Immune System Diseases

Interventions

Type	Name	Description
DRUG	Doxycycline hyclate	Tab. Doxycycline 50 mg PO per day for 12 weeks
DRUG	Placebo	Tablet placebo for 12 weeks

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2014-07-30
• Last updated: 2021-11-17

Locations

1 site across 1 country: China