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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01904-51 | Other Identifier | ID-RCB number, ANSM |
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departure of Pr MORDON from the ONCOTHAI unit
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Tampere University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532nm KTP Laser | Active Comparator | 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. |
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| 585 nm yellow laser | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excel V 532nm (KTP) green Laser | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Month 4, 6,12 |
| Measures of skin reaction for each treatment arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyril MAIRE, MD | University Hospital, Lille | Principal Investigator |
| Serge MORDON, Pr | Institut National de la Santé Et de la Recherche Médicale, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| PHOTOLASE PLV 585 nm yellow laser | Device | 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 |
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Measured with a 4 points scale : no reaction, low, moderate and severe reaction |
| At baseline, At Month 2, At Month 4 (if realized) |
| Pain evaluation during each treatment | Mosby Pain Rating Scale for each treatment arm | 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 | At Baseline, at Month 2, 4, 6,12 |
| Subject satisfaction level | Comparison of each treatment arm using Subject Overall Evolution Scale | At Month 6,12 |
| Change in Life Quality | Comparison of Dermatology Life Quality Index | 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 | 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 | At Baseline, At Month 2, 4, 6,12 |