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This study was designed as a single-center, prospective, randomized controlled trial and included 80 patients with rosacea treated at the Department of Dermatology, Jiangsu Provincial People's Hospital. All patients received pulsed dye laser therapy (pulsed dye laser system; Cynosure (Beijing) Medical Technology Co., Ltd., China). Treatment energy was adjusted according to individual clinical responses, with no concomitant therapies administered. All patients were informed of study-related precautions and provided written informed consent prior to enrollment.
Each patient underwent a single session of bilateral facial 595-nm pulsed dye laser treatment with randomized pulse durations of 6 ms or 10 ms, using a fluence of 9-11 J/cm² and a 7-mm spot size, followed by post-treatment epidermal cooling. Skin imaging was performed at baseline and at 1 month after treatment. At 3 and 7 days post-treatment, erythema improvement, pain visual analog scale (VAS) scores, and adverse events were assessed using questionnaires. At 1 month, treatment efficacy and safety were evaluated based on erythema improvement, patient satisfaction, Clinical Erythema Assessment (CEA) score, Investigator's Global Assessment (IGA) score, Rosacea Area and Severity Index (RASI) score, skin imaging analysis, and adverse event records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6ms-pulse group | Active Comparator |
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| 10ms-pulse group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulse duration, 6ms | Device | The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 6ms; with a dynamic spray cooling device was used during this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Erythema Assessment (CEA) score | Clinician's Erythema Assessment (CEA) scale Scores 0= clear Clear skin with no signs of erythema 1 = Almost clear Slight redness; almost clear 2=mild Definite redness; mild erythema 3 = moderate Marked redness; moderate erythema 4= severe Fiery redness; severe erythema This scale assesses the average facial erythema condition over 24 hours.For CEA scoring, which were evaluated masked by two well-trained dermatologists. when two dermatologists have different scores, the one with the higher score will be included in the statistics | From enrollment to the end of treatment at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| pulse duration, 10ms | Device | The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 10ms; with a dynamic spray cooling device was used during this study. |
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