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临床试验/NCT07729540
NCT07729540已完成不适用

Intense Pulsed Light, a Targeted Anti-Redness Dermocosmetic Regimen, and Their Combination for Erythematotelangiectatic Rosacea: A Comparative Study Using Antera 3D Chromophore Mapping, Grey-Level Co-Occurrence Matrix Texture Analysis and Clinician Erythema Assessment Scale.

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Antera 3D Erythema Index (Mean, Minimum, and Maximum)

研究概览

简要总结

This study compares three approaches to treating persistent facial redness in adults with erythematotelangiectatic rosacea: intense pulsed light (IPL) treatment alone, a professional anti-redness dermocosmetic skincare regimen alone, and the combination of both. The main question the study aims to answer is which of these three strategies is more effective at reducing facial redness, using both clinician grading and objective skin-imaging tools that measure redness and skin texture before and after treatment.

详细描述

This was a prospective, single-center, three-arm comparative study conducted in an outpatient setting, with 60 adult patients with a dermatologist-confirmed diagnosis of erythematotelangiectatic rosacea allocated to one of three parallel treatment groups (20 patients per group). No randomization or blinding was performed.

Group 1 (IPL) received three intense pulsed light treatments with the Lumecca applicator (InMode; 515-1200 nm) at 21-day intervals, with fluence individually titrated to skin response; broad-spectrum SPF 50+ sunscreen was applied after each session, and daily photoprotection was mandatory.

Group 2 (dermocosmetic) received four professional in-office anti-redness treatments using the Rosacure Professional system (Synchroline/Cantabria Labs) at 7-day intervals - gentle cleansing, application of Rosacure Professional Serum Booster, and a leave-on regenerating gel mask - together with a standardized 12-week home-care regimen (twice-daily gentle cleanser, Rosacure Intensive SPF 30 in the morning, Rosacure Fast in the evening, and a leave-on mask twice weekly).

Group 3 (combination) received the same three IPL treatments as Group 1, immediately followed within the same session by the professional Rosacure protocol, at 21-day intervals, together with the same home-care regimen used in Group 2.

Facial redness was assessed using objective imaging (Antera 3D chromophore mapping and Gray-Level Co-occurrence Matrix texture analysis) and by clinician grading, at baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 57 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with a dermatologist-confirmed diagnosis of erythematotelangiectatic rosacea

排除标准

  • Age under 18 years
  • Pregnancy or breastfeeding
  • Predisposition to keloid or hypertrophic scarring
  • Use of systemic or topical retinoids, antibiotics, or hormonal therapy within the washout period specified for each agent
  • Chemical peeling within one month
  • Laser treatment or phototherapy within three months
  • Photosensitizing medications or herbal preparations
  • Inflammatory dermatoses other than rosacea
  • Autoimmune disease
  • Active skin infection in the treatment area

结局指标

主要结局

Antera 3D Erythema Index (Mean, Minimum, and Maximum)

时间窗: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

Erythema quantified via the Antera 3D camera (Miravex, Dublin, Ireland), which reconstructs hemoglobin distribution from multidirectional, multispectral light reflectance and expresses erythema on a reproducible relative scale. For each patient and time point, three erythema indices - mean, minimum, and maximum - were extracted for the left and right cheek and averaged into a single value per index.

次要结局

  • GLCM Contrast(Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series)
  • GLCM Homogeneity(Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series)
  • Clinician Erythema Assessment (CEA) Score(Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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