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临床试验/CTRI/2024/05/066976
CTRI/2024/05/066976尚未招募3 期

A split-neck interventional study to compare the efficacy of Ablative Fractional CO2 laser vs 70% Glycolic acid peel in Acanthosis nigricans

Command Hospital Air Force, Bangalore1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年5月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
53
试验地点
1
主要终点
1)change in texture of skin

研究概览

简要总结

A split-neck interventional study to compare the efficacy of ablative fractional laser vs 70% glycolic acid peel in acanthosis nigricans is to be conducted in patients attending dermatology OPD in Command Hospital Air Force bangalore. Aesthetic concerns become valid when acanthosis nigricans affects the visible areas. Treating it early prevents worsening of the condition.

Randomisation will be done by tossing a coin and following procedure will be done :

 Acanthosis nigricans on one  side of neck will be treated with glycolic acid peel. First coat of the peeling will be applied and the frosting is  expected; if no frosting formed, a second coat will be applied. Sodium bicarbonate application follows to neutralize the peeling effect, and emollient will be advised for patient for 1 week after peeling. Each patient will have three sessions of glycolic acid peel with 2-weeks interval.

  Other side of  neck will be treated  with ablative fractional CO2 laser.

Each patient will have three sessions of fractional CO2 laser , with 2-weeks interval. The parameters will be  atleast of low power (10 J), low density (500 μm), short dwell time (500 μs), and double stacking with a single pass on the affected area. Test area will be performed first to detect side effects to treatment. Post-operatively, ice packs for cooling will be  immediately applied after laser sessions,and the patients will be advised to apply a topical antibiotic with steroid ointment and emollient after the session

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • age more than 15 years 2)clinically diagnosed case of acanthosis nigricans.

排除标准

  • patients already on treatment for acanthosis nigricans 2)patients with hypersensitivity to glycolic acid.

结局指标

主要结局

1)change in texture of skin

时间窗: 3 to 4 months

2)decrease in pigmentation

时间窗: 3 to 4 months

次要结局

  • 1)Increase in efficacy of topical treatments(2)Decrease in skin thickness)

研究者

发起方
Command Hospital Air Force, Bangalore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dinesh Kumar

Command Hospital Air Force Bangalore

研究点 (1)

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