Rosacea Clinical Trial
Official title:
Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
The goal is to compare a novel yellow laser, based on semiconductor technology, with traditional green laser, in the treatment of cheek telangiectasias. The trial design is randomized split-face double-blinded study with 20-30 volunteers. The improvement will be assessed using a 7-point Telangiectasia Grading Scale.
Trial design: The study is a comparative randomized split-face double-blinded study without a
control group. It enables a comparison between two lasers; namely the KTP laser and the
investigational PHOTOLASE laser. The split-face design eliminates the individual biases and
the randomization eliminates the possible small variations in the symmetry of the
telangiectasias on the face. The double-blinded assessment eliminates the physicians' and the
subjects' subjective and objective bias.
Methods: The subjects will be treated with a 532-nm green KTP laser and a 585-nm yellow
PHOTOLASE laser; different laser on each side of a face. A total of one or two treatments
will be given based on the response of the first treatment. The improvement of subjects'
telangiectasia will be graded after the final treatment according to a 7-point Telangiectasia
Grading Scale (TGS) by a blinded physician using images taken with Visia imaging system. The
usability, reliability and treatment characteristics of PHOTOLASE laser will be qualitatively
assessed by the treating physicians (not blinded).
Objectives: The primary objective is to assess how the PHOTOLASE laser compares to the KTP
laser in the treatment of facial telangiectasia in terms of the treatment outcomes. The
secondary objective is to assess the usability, reliability and treatment characteristics of
the PHOTOLASE laser from the perspective of the user.
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