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临床试验/NCT06867276
NCT06867276已完成不适用

Low Level Laser Versus Polarized Light in the Treatment of Acne Vulgaris

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
assessment of change of Global Assessment Scale

研究概览

简要总结

The present study is designed to compare clinically the therapeutic applications between low level laser therapy (excimer laser) and non-laser polarized light (Bioptron prol) in the treatment of Acne vulgaris.

详细描述

Traditional acne treatment often involves topical application, which can cause skin irritation and dryness, and oral antibiotic therapy, which is limited by antibiotic resistance. Newer procedures like laser and light-based therapies offer alternative treatments for patients who struggle with adherence or experience side effects or treatment failure. This study aims to compare the therapeutic application of laser and light therapies as an alternative to traditional acne treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Female and male patients.
  • •Age range between 18 and 25 years.
  • •All patients will sign their informed consent to participate in the research procedure and to publish the data.
  • •Definite clinical diagnosis of mild to moderate inflammatory lesions of facial Acne vulgaris (open and closed comedones, papules, pustules, and nodules) on the face that has been going on for at least 1 month.

排除标准

  • •Patient's unwillingness to continue cooperation in the study
  • •Photosensitive skin.
  • •Pregnancy and breast feeding.
  • •Women who use hormonal contraceptives.
  • •Patients who had used oral retinoids or any other treatment for acne in the last month.
  • •Patients with severe nodulocystic acne

研究组 & 干预措施

Excimer laser

Experimental

This group includes 25 patients; all the participants received low level laser (Excimer laser) in a series of eight treatment sessions that was performed twice per week. The radiation exposure time is 10 minutes during the procedure, a maximum dose of 0.65 J/cm², and 6 different spot sizes to avoid healthy skin. large spot size (20 cm²).

干预措施: Excimer laser (Device)

Bioptron

Active Comparator

This group includes 25 patients; all the participants received polarized light (Bioptron Pro l) in a series of eight treatment sessions that was performed twice per week. The radiation exposure time is 10 minutes during the procedure; a device is fixed at a distance of 10 cm from the treatment area (face), light spot size 19 cm2 average power density is 40 mille watt per cm², and a dose of 2.4 J/cm² per minute.

干预措施: Bioptron Pro 1 (Device)

结局指标

主要结局

assessment of change of Global Assessment Scale

时间窗: At baseline and after 4 weeks

For the study, we recruited males and females with mild to moderate acne according to the Investigator's Global Assessment (IGA) scale, where the severity of acne and the type of lesions was assigned to it. the scoring ranges from 0 to 4. Zero indicates clear skin with no inflammatory and non- inflammatory lesions, while 4 indicates severe lesion with Many comedones and inflammatory lesions, ≤ several nodules and cysts

次要结局

  • assesment of change of digital facial photographs(At baseline and after 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sohila Mamdouh Morsy Mohamed

principal investigator

Cairo University

研究点 (1)

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