An interventional study of Excel V 532nm (KTP) green Laser and PHOTOLASE PLV 585 nm yellow laser in Erythematotelangiectatic Rosacea, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment
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.
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.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 1 is below the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
Cutera® Excel V 532 nm Application of light spots 5 to 7 mm for a pulse duration of 8 to 20 ms and a fluence of 7.4 to 10 J / cm2.
Device: Excel V 532nm (KTP) green Laser
PHOTOLASE PLV 585 nm Application of light spots 1.4mm for a pulse duration of 10 to 100 ms and a fluence of 0 to 65 J / cm2.
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
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
Degree of improvement in Erythematotelangiectatic Rosacea
Measured, for each treatment arm, based on blinded physician assessment of subject photographs using the 7 points Telangiectasia Grading Score. (-1 = Aggravation of telangiectasia, 0 = no change, 1 = poor improvement (\<25% decrease), 2 = intermediate improvement (25-50% decrease), 3 significant improvement (50-75% decrease), 4 = very significant improvement (75-99% decrease), 5 = complete improvement (100% decrease)
Time frame: at Month 2
Degree of improvement in Erythematotelangiectatic Rosacea evaluated by a blinded physician.
Measured, for each treatment arm, based on subject photographs using the 7 points Telangiectasia Grading Score
Time frame: at Month 4, 6,12
Measures of skin reaction for each treatment arm
Measured with a 4 points scale : no reaction, low, moderate and severe reaction
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Pain evaluation during each treatment
Mosby Pain Rating Scale for each treatment arm
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Change in lesion skin color in each treatment arm
Measured with Chroma-Meter CR400 (Konica Minolta), Mean a\* value
Time frame: At Baseline, at Month 2, 4, 6,12
Subject satisfaction level
Comparison of each treatment arm using Subject Overall Evolution Scale
Time frame: At Month 6,12
Change in Life Quality
Comparison of Dermatology Life Quality Index
Time frame: At Selection, at Baseline, at Month 2, 4 (if realized), 6,12
Practitioner's opinion
Comparison, for each treatment arm, of comfort of use, practicality, duration of treatment
Time frame: At baseline, At Month 2, At Month 4 (if realized)
Adverse Events
Incidence and severity of adverse effects, for each treatment arm, during the study period
Time frame: At Baseline, At Month 2, 4, 6,12
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille