跳至主要内容
临床试验/NCT05771298
NCT05771298招募中不适用

Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Case-Control Study

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
reduction of erythema

研究概览

简要总结

To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.

详细描述

Rosacea is a common, chronic inflammatory skin disease that usually affects the cheeks, nose, forehead, and chin [1]. Clinically, it presents initially with transient erythema (flushing) and telangiectasia. As it progresses, persistent erythema and papules and pustules appear. Phymatous changes result from hypertrophy of the sebaceous glands, and usually manifest as rhinophyma, gnatophyma, and metophyma [2]. Depending on the literature, rosacea has a prevalence of 1% to 22% [3]. Time of manifestation of the disease is usually between 30 and 50 years [4]. Women are more frequently affected [4].

For laser treatment of rosacea, the pulsed dye laser (PDL) with a wavelength of 595nm is frequently used. The treatment includes at least three sessions at intervals of about 4 weeks and leads to lightening and reduction of the lesions as well as reduction of papules and pustules. Various clinical studies have already demonstrated the high efficacy of PDL [5-7]. The treatment is painless, and local or general anesthesia is not necessary.

The KTP laser is also an option in the treatment of rosacea. Due to the more stable technology of the frequency-doubled Nd:YAG (KTP) and associated lower maintenance problems, this laser system appears to be a safer and more reliable treatment option for rosacea patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women 18 years and older
  • Good general health, no relevant previous diseases
  • Presence of rosacea
  • Cognitive ability and willingness to give consent (Informed Consent)

排除标准

  • Age < 18 years
  • Pregnant and breastfeeding women
  • Significant open wounds or lesions of the region to be treated
  • Metallic implants in the region to be treated
  • Missing consent and/or data protection declarations

结局指标

主要结局

reduction of erythema

时间窗: at follow-up visit 4 weeks after last treatment session

assessment scale 0 - 4 (normal skin - severe erythema) evaluated by physician and blinded investigator

pain intensity

时间窗: at follow-up visit 4 weeks after last treatment session

using numeric rating scale 0 - 10 (none - unbearable pain) evaluated by subjects

swelling

时间窗: at follow-up visit 4 weeks after last treatment session

assessment scale 1 - 6 (very - none) evaluated by subjects

purpura

时间窗: at follow-up visit 4 weeks after last treatment session

assessment scale 1 - 6 (very - none) evaluated by subjects

次要结局

  • patient satisfaction(at follow-up visit 4 weeks after last treatment session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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