NCT02935660已完成不适用
A Prospective, Multi-Center Pivotal Clinical Evaluation of a Novel Multi-Wavelength Laser for Tattoo Removal
Cutera Inc.4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年10月1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
- 27
- 试验地点
- 4
- 主要终点
- Tattoo Clearing as Rated by Blinded Evaluator
研究概览
简要总结
Multi-center study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal
详细描述
A multi-center prospective, open-label, uncontrolled pivotal study to evaluate the safety and efficacy of an investigational version of the Cutera enlighten laser that offers multiple wavelengths for tattoo removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, and must include blue and/or green ink.
- •Target tattoos must be older than 1 year.
- •Target treatment area not to exceed 12 square inches.
- •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 per investigator's discretion.
- •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, as applicable, within 6 months of study participation.
- •Anytime in life, having 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
Tattoo Clearing as Rated by Blinded Evaluator
时间窗: 6 weeks post-final treatment, approximately 7 months after study start
Percentage of subjects with tattoo ink clearing of at least 50% or more at 6 weeks post-final treatment
次要结局
- Subject Pain During Treatment(Reported by subject at the end of each treatment visit, up to 5 months)
- Subject Satisfaction Levels at 6 Weeks Post-final Treatment(6 weeks post-final treatment, approximately 7 months after study start)
- Degree of Overall Tattoo Ink Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator (Physician's Global Assessment of Improvement).(6 weeks post-final treatment, approximately 7 months after study start)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne ScarsAcne Scars - Mixed Atrophic and HypertrophicNCT03284333Cutera Inc.45
已完成
不适用
Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece AttachmentScarringAcneNCT03430921Cutera Inc.4
已完成
不适用
Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle ReductionWrinkle ReductionNCT03285581Cutera Inc.39
已完成
不适用
Coronary Crossing System in Patients With Coronary Chronic Total OcclusionsChronic Total Occlusion of Coronary ArteryNCT05813704Shanghai MicroPort Rhythm MedTech Co., Ltd.159
已完成
不适用
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)Coronary Artery CalcificationNCT05818098Shanghai MicroPort Rhythm MedTech Co., Ltd.189