跳至主要内容
临床试验/CTRI/2025/11/096766
CTRI/2025/11/096766尚未招募4 期

A split tattoo comparative evaluation of sequential QS nanosecond laser followed by QS picosecond laser versus QS picosecond laser alone in tattoo removal: a prospective study

NA1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月14日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Efficacy of tattoo removal: Assessed as the percentage of tattoo clearance using Physician Global Assessment (PGA) scale at baseline and after 4 treatment sessions (week 16)

研究概览

简要总结

Laser tattoo removal was first reported by Goldman et al., and its mechanism is explained by the principles of selective photothermolysis and photoacoustics.According to photothermal theory, laser energy is selectively absorbed by pigment particles, and the optimal pulse duration should be less than or equal to the thermal relaxation time (TRT) of the chromophore. Photon absorption also generates pressure waves, which form the basis of inertial confinement time (ICT). When the laser pulse duration is shorter than the ICT, strong photoacoustic forces rupture the pigment particles. Thus, both theories emphasise the importance of selecting an appropriate wavelength and pulse width for effective and safe tattoo clearance.

Q-switched nanosecond (NS) lasers have long been considered the gold standard due to the selective photothermolysis of tattoo pigments. However, multiple sessions are usually required, with incomplete clearance and risk of pigmentary changes or scarring.

Picosecond (PS) lasers, which have emerged in recent years, are a strong competitor of NS lasers. They have demonstrated superior efficacy by delivering higher peak power with shorter pulse durations, resulting in more effective photomechanical pigment fragmentation and potentially fewer sessions.

Split-tattoo and intra-tattoo comparative trials have generally shown PSL to be superior or at least non-inferior to NSL for many pigments, but most published split studies compare each modality used alone (NSL vs PSL).

Although QS nanosecond lasers remain widely used, and the sequential use of NS followed by PS lasers has been proposed to maximise efficacy, combining the deeper penetration of NS pulses with the finer fragmentation of PS pulses. This sequential approach may enhance tattoo clearance while limiting side effects.

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 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Adults 18 to 70 years willing to consent.
  • •2.One or more stable tattoos (professional or amateur), greater than or equal to 3 months old.
  • •3.Tattoo containing single or multi-colour ink.
  • •4.Agree not to undergo any other tattoo removal procedure during the treatment duration.

排除标准

  • •1.Associated photo-aggravated skin diseases and medical illnesses, for example, SLE.
  • •2.Treatment area with active cutaneous infection or inflammation.
  • •3.Unstable vitiligo and psoriasis 4.Tattoo granuloma 5.Localised allergic reactions within a tattoo 6.Recent sun exposure in the past 3 weeks 7.Immunosuppression or uncontrolled systemic disease 8.History of keloid and keloidal tendency 9.Personal or family history of skin cancer 10.Photosensitising or gold-containing medication 11.Pregnancy or lactation 12.Seizure disorder 13.Patient not willing to participate in the study.

结局指标

主要结局

Efficacy of tattoo removal: Assessed as the percentage of tattoo clearance using Physician Global Assessment (PGA) scale at baseline and after 4 treatment sessions (week 16)

时间窗: After 4 months

次要结局

  • The study will assess the efficacy of tattoo removal as the percentage of clearance using the Physician Global Assessment (PGA) scale at baseline and after 4 treatment sessions (week 16). Pain during treatment will be recorded using the Visual Analogue Scale (VAS 0–10) at each session, patient satisfaction will be evaluated on a Likert scale (1–5) after completion of all sessions, and any adverse effects will be documented and graded according to severity.(After 4 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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