30
Participants
Start Date
November 30, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
reSEES
"The treatment consists of combining SMPL and PBM light therapies to exploit the full advantage of their action. The combination will result in an additive or synergetic effect.~* Treatment sessions are scheduled for three weeks after enrolment (Loading-Phase).~* Two visits per week are needed.~* At the first visit of every treatment week, two treatment sessions will follow each other; PBM is applied at least 15' after SMPL (treatment pairs).~* Only PBM will be administered during the second visit of every treatment week.~Patients will receive:~* 1x SMPL treatment at days 0, 7, and 14 (3 in total),~* 1x PBM treatment at days 0, 3, 7, 10, 14, and 17 (6 in total)~Nine treatments will be delivered within three weeks. The study will be concluded with three follow-up visits at 18, 24, and 54 weeks."
RECRUITING
Humanitas Castelli, Bergamo
Lead Sponsor
Latis S.r.l.
INDUSTRY
Oculox Technologies SA
INDUSTRY