NCT03708263

Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea

A Single-blinded, Monocentric, Randomized Pilot Study, to Evaluate the Yellow Laser PHOTOLASE PLV-585nm Versus the Reference Green Laser (KTP Excel V 532 nm) in the Treatment of Erythematotelangiectatic Rosacea

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). It frequently affects men and women with fair skin and can have significant psycho-emotional consequences. To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of the laser is proposed to the patient. This study is a single center prospective, randomized, controlled split face study to compare 532nm KTP laser versus 585 nm PLV Laser in terms of improvement of the symptoms in the treatment of Erythematotelangiectatic Rosacea 20 subjects will receive up to 3 laser treatments at day 0, month 2 and 4 and will be followed at month 6 and 12.

Detailed description

Adult male and female subjects 18 years of age or older will participate in the study after the objectives, methods, and potential risks of the study have been explained, and after they have signed the informed consent form. Patients will come to the investigation center for a maximum of 6 visits.

Conditions

• Erythematotelangiectatic Rosacea

Interventions

Type	Name	Description
DEVICE	Excel V 532nm (KTP) green Laser	Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of active comparator and experimental treatment arms will be determined by randomization
DEVICE	PHOTOLASE PLV 585 nm yellow laser	Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of active comparator and experimental treatment arms will be determined by randomization

Timeline

• Start date: 2020-09-08
• Primary completion: 2021-09-14
• Completion: 2021-09-14
• First posted: 2018-10-17
• Last updated: 2022-03-15

Locations

1 site across 1 country: France