Date

2018-06-07

Protocol

Protocol changed

Item Changed

Secondary outcome

Previous Version

1. Improvement or halt of progression (Lack of progression) of LE when examined 12 months after treatment onset 2. Improvement of LE when examined 12 and 24 months after treatment onset 3. Change of LE stages (reduction or increase) compared to baseline assessed at 12 and 24 months 4. Change in the circumference of the affected limb from baseline 5. Reduction in the frequency of acute dermato-lymphangio-adenitis (ADLA) attacks evaluated from 0-12 months and from 12-24 months after treatment onset 6. Changes in skin thickness at 12 and 24 months compared to the baseline 7. Change in angiogenic, pro-fibrotic or pro-inflammatory biomarkers at 12 and 24 months following doxycycline administration (at sites where these tests are done)

Next Version

1. Improvement or halt of progression (Lack of progression) of LE when examined 12 months after treatment onset 2. Improvement of LE when examined 12 and 24 months after treatment onset 3. Change of LE stages (reduction or increase) compared to baseline assessed at 12 and 24 months 4. Change in the circumference of the affected limb from baseline 5. Change in circumference through Lymphatech 3D-camera measurement compared to baseline 6. Change in volume through Lymphatech 3D-camera measurements compared to baseline 7. Reduction in the frequency of acute ADLA attacks evaluated from 0-12 months and from 12-24 months after treatment onset 8. Changes in skin thickness at 12 and 24 months compared to the baseline 9. Change in angiogenic, pro-fibrotic or pro-inflammatory biomarkers at 12 and 24 months following doxycycline administration (at sites where these tests are done)