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临床试验/CTRI/2025/05/086774
CTRI/2025/05/086774招募中2/3 期

Comparing the Efficacy of Combination of Q-Switched Nd:YAG and Fractional CO2 Lasers versus Q-Switched Nd:YAG Laser alone in Melasma: A Split-face Randomised Controlled Trial

AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年5月22日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
AIIMS Jodhpur
入组人数
48
试验地点
1
主要终点
Comparing efficacy of both groups by the change in modified MASI score and Physician Global Assessment (PGA) score.

研究概览

简要总结

Patients with clinically diagnosed melasma visiting the Dermatology OPD at AIIMS Jodhpur during the study period will be recruited based on inclusion and exclusion criteria after a written informed consent. Through our study we want to find whether the combination of Q-switched Nd:YAG and Fractional CO2 lasers provide better clinical improvement than Q-switched Nd:YAG laser alone in Melasma. This split-face randomized controlled trial will last approximately 18 months. Using block randomization method we will randomly assign one half of the face to receive both lasers, while the other half will receive only the Q-switched Nd:YAG laser. After the patient is recruited, he/she will be started on topical sunscreen with spf>30. The first laser session will be held after 4 weeks, followed by sessions every 2-4 weekly. Q-switched Nd:YAG laser will be done every 2 weekly while Fractional Co2 laser will be done monthly. A total of 6 sittings of Q-switched Nd:YAG and 3 sittings of Fractional Co2 will be done in combination group while only 6 sittings of Q-switched Nd:YAG laser will be done in another group. We will compare efficacy using Photography, Modified MASI scoring, Physician Global Assessment (PGA) scoring, and dermoscopic evaluation, and monitor side effects. All information will be recorded on a pre-designed proforma, and photographic records will be maintained. Patient satisfaction will be measured using a percentage-graded score. Final assessment will be done 2 weeks after the last laser session. Our study can help us understand the effect of combination of Q-Switched Nd:YAG and Fractional CO2 lasers in Melasma better. Also it will guide us in formulating standardized laser protocol for Indian Melasma patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed Melasma.

排除标准

  • Any one of the following-
  • Pregnant and/ or lactating women
  • Women taking oral contraceptives or hormonal replacement therapy
  • Patients taking oral or topical treatment for Melasma 4 weeks prior to the study
  • Any known systemic illness
  • Active skin disease present locally
  • History of Photosensitive disorder
  • Patients having keloidal tendency
  • Bleeding diathesis
  • Unwilling to participate.

结局指标

主要结局

Comparing efficacy of both groups by the change in modified MASI score and Physician Global Assessment (PGA) score.

时间窗: At each follow up visit. Final assessment will be done 2 weeks after the last session.

次要结局

  • 1. To assess dermoscopic changes in both treatment groups.(2. To observe and assess side effects in both treatment groups)

研究者

发起方
AIIMS Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Piyush Meena

AIIMS Jodhpur

研究点 (1)

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