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临床试验/CTRI/2024/12/077588
CTRI/2024/12/077588尚未招募不适用

Safety and efficacy of standard PICO second laser alone and in combining with fractional picosecond laser in the treatment of tattoo removal - a prospective split study.

NA1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年12月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
10
试验地点
1
主要终点
1.To determine the efficacy of standard picosecond laser in the treatment of tattoo removal

研究概览

简要总结

Tattooing is an ever-increasing phenomenon and has become an accepted form of beautification, self-expression, and art. As commonly as people get themselves tattooed, many of them seek its removal at some point in time. Lasers have superseded other older modalities of tattoo removal such as dermabrasion, salabrasion, chemical cauterization/ peel, cryotherapy, and surgical excision.

Laser therapy is the gold standard method to remove unwanted tattoos.1 It is available and widely accessible. In the 1980s, the vaporizing CO 2 and erbium:YAG lasers, and argon lasers, were used to remove tattoo pigment but again resulted in scarring.

Anderson and Parrish’s principle of selective photothermolysis revolutionized the treatment of tattoos.2 whereby an extremely short pulse width was delivered less than the thermal relaxation time (TRT) of a target.

The Q-switched laser has pulse duration in nanosecond (10-9 of a second). If the pulse duration is narrowed further, the peak energy of the laser beam becomes very high. The picosecond lasers have a pulse duration of (10-12 of a second).3 A variety of holographic or diffractive lens arrays can be used to produce fractional picosecond laser energy. These arrays allow the energy to be concentrated within laser microbeams, while neighboring tissue between the microspots is unharmed.4

Commercially available fractional optical delivery technologies include, diffractive lens arrays (DLA), micro-lens arrays (MLA), and holographic optical arrays.5 Nanosecond laser treatment relies mainly on photothermolysis rather than photomechanical effects; however, picosecond lasers rely mainly on photoacoustic destruction.6 This approach can enhance the energy transmitted to target cells within the lesion, and avoid thermal damage to surrounding tissues. 7

This results in more rapid heating of the tattoos and finer fragmentation. The lymphatic elimination of these finer particles is easier resulting in faster clearing of the tattoos.3 In 2012, the FDA approved the first picosecond laser for skin applications (Picosure, Cynosure, Westford, Massachusetts).8 The picosecond lasers with pulse durations in the range of 450–750 ps were introduced commercially in early 2013. At present, there are three or more systems with a wavelength of 755 nm and 1,064 nm and a pulse duration of 450–750 ps.8

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • All Patients of age 18 to 60 years wants to remove unwanted tattoos Patients willing to participate in the study with their informed consent Patients not undergoing any other treatment for the same.

排除标准

  • Associated photoaggravated skin diseases and medical illness, for example, systemic lupus erythematosus.
  • Unstable vitiligo and psoriasis for risk of Koebnerization of the treated area.
  • Tattoo granuloma Patients with skin malignancy Pregnancy and Lactation women Bindi tattoo Have taken any treatment in the past for tattoo removal.

结局指标

主要结局

1.To determine the efficacy of standard picosecond laser in the treatment of tattoo removal

时间窗: After 6 months

3.Efficacy of the Fractional Picosecond laser and standard Picosecond laser in tattoo removal

时间窗: After 6 months

次要结局

  • Physician global assessment (PGA) evaluation using four point scale with Grades of 1 minimal, 2 moderate, 3 marked and 4 near total improvement. Baseline and at weeks 6,12,18 and 24 weeks(After 6 months)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Chaithra Shenoy

CUTIS Academy of Cutaneous Sciences

研究点 (1)

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