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临床试验/NCT07250165
NCT07250165已完成不适用

Prospective, Single-arm, Open-label Study of Efficacy and Safety of 532 nm KTP and Microsecond 1064 nm Nd:YAG Laser in Rosacea

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
CEA scores

研究概览

简要总结

Rosacea remains a therapeutically challenging, chronic facial dermatosis whose central feature-persistent erythema-often resists topical and systemic agents. In this study we evaluated, for the first time, the simultaneous use of a 532-nm potassium titanyl phosphate (KTP) laser and a microsecond-pulsed 1064-nm Nd:YAG laser as a safe alternative.

详细描述

Rosacea is an extremely common condition characterised by facial flushing, dilated capillaries and papules and pustules. Both systemic and topical treatments have their drawbacks, such as limited efficacy, intolerable adverse reactions, drug resistance and high recurrence rates. Therefore, it is necessary to explore new treatment methods for rosacea.

Lasers have been used for more than three decades to treat vascular lesions with an excellent safety profile and very low risk of scar formation. Purpura was a common side effect of the previous generation of lasers and has been significantly reduced with the introduction of newer devices. The 532-nm potassium titanyl phosphate (KTP) laser is used for treating vascular cutaneous lesions due to its selective absorption by haemoglobinn, while rarely inducing purpura. However, the 532-nm KTP laser is primarily effective for superficial blood vessels. The long-pulsed 1064-nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser can penetrate up to 4-6 mm beneath the skin and is effective in treating larger blood vessels. Previous studies have demonstrated that the long-pulsed 1064-nm Nd:YAG laser is effective for both erythematotelangiectatic rosacea (ETR) and papulopustular rosacea (PPR). However, traditional millisecond-domain devices should still be used with caution in darker skin types, and it is associated with an extensive zone of thermal injury and a heightened risk of scar formation. In contrast to millisecond 1064-nm Nd:YAG lasers, microsecond-pulsed lasers deliver energy within the thermal relaxation time of the epidermis, minimizing heat diffusion to surrounding tissues.

Rosacea is a chronic and recurrent dermatologic condition that poses significant therapeutic challenges. While both 532-nm KTP and 1064-nm Nd:YAG lasers demonstrate efficacy in managing rosacea-associated erythema, no single laser system can address all vascular components due to their distinct limitations in penetration depth and vessel selectivity. We need to explore more treatment options. This study aims to evaluate the efficacy and safety of a 532-nm KTP laser combined with a microsecond 1064-nm ND:YAG laser in treating the erythema of rosacea, in order to provide scientific evidence for clinical application.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged between 18 and 65 years, without cognitive impairments, and of any gender
  • Patients must meet the 2017 rosacea diagnostic criteria updated by the National Rosacea Society Expert Committee
  • The severity of rosacea must be scored at least 2 points on the Clinician's Erythema Assessment (CEA) scale.

排除标准

  • if they had undergone any treatments that could influence the prognosis of rosacea within the preceding 8 weeks
  • if they had taken photosensitizing or phototoxic medications within the same period
  • the presence of other facial conditions that might confound the efficacy assessment
  • participation in any drug clinical trial as a subject within the last month
  • the presence of severe concurrent diseases

结局指标

主要结局

CEA scores

时间窗: Baseline to Week 9

Change from baseline in Clinician Erythema Assessment (CEA) at Week 9; scored 0-4 by blinded photograph review.

CEA success

时间窗: Baseline to Week 9

A decrease in CEA of 1 or more is considered as a CEA success

次要结局

  • DLQI score(Baseline to Week 9)
  • GAIS score(Week 9)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Sun

Attending Physician

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (1)

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