NCT02912507已完成不适用
An Open Label, Split-tattoo Study Comparing the Safety and Efficacy of the 670nm Picosecond Laser Versus the 755 nm Picosecond Laser for Tattoo Removal
Cutera Inc.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年9月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
研究概览
简要总结
Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser
详细描述
This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single or multi-color ink. Subjects will receive laser treatments, and will be followed at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or Male, 18 to 65 years of age (inclusive).
- •Fitzpatrick Skin Type I - VI.
- •Target tattoo contains single or multi-color ink.
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.
- •Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- •Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).
- •Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study.
排除标准
- •Participation in a clinical trial of a drug or another device in the target area during the study.
- •Target tattoo contains only black ink.
- •History of allergic reaction to pigments following tattooing.
- •History of allergy to local anesthetics.
- •History of allergy to topical antibiotics.
- •History of malignant tumors in the target area.
- •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- •Pregnant and/or breastfeeding.
- •Having an infection, dermatitis or a rash in the treatment area.
- •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of vitiligo, eczema, or psoriasis.
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •History of seizure disorders due to light.
- •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
- •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
- •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •Current smoker or history of smoking within 6 months of study participation.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
结局指标
主要结局
Degree of Tattoo Clearing as Assessed by the Investigator (Physician's Global Assessment of Improvement)
时间窗: 6 weeks post-final treatment, an average of 8 months from baseline
Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant or Complete Clearing 3= Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Study of Picosecond and Nanosecond Q-switched Lasers for Tattoo RemovalTattoo RemovalNCT01973166Cutera Inc.42
撤回
不适用
Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic AlopeciaAndrogenetic AlopeciaNCT05129254Montefiore Medical Center
已完成
不适用
A Study of a Novel Multi-Wavelength Laser for Tattoo RemovalTattoo RemovalNCT02910505Cutera Inc.8
招募中
不适用
A Study of a Laser for the Treatment of Acne VulgarisAcne VulgarisNCT05430464Cutera Inc.30
已完成
不适用
Study of Light Treatment and Laser Treatment for MelasmaMelasmaNCT00509977Northwestern University17