Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 7
- 主要终点
- Investigator's Global Assessment of Improvement
研究概览
简要总结
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
详细描述
This pilot clinical trial will evaluate the capability of the Lutronic PicoPlus technology to remove unwanted tattoos and benign pigmented lesions. This trial is designed as a multi-center exploratory, open-label clinical trial comparing each subject's condition before and after treatment. Subjects meeting all entrance criteria will be assigned to Group A for treatment of unwanted tattoos and Group B for treatment of unwanted benign pigmented lesions, melasma, or other skin conditions such as skin rejuvenation. Subjects in each treatment group will receive a series of treatments, e.g., 2-5, and will be asked to complete 1 and 3 month follow-up visit(s) following each treatment to assess treatment efficacy and safety. At investigators' discretion, additional follow-up visits, e.g., at 6 months following treatment, may take place to observe the time course of reactions after treatment and/or assess efficacy. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photos will be obtained at baseline; post-treatment study photos will be obtained at each post-treatment follow-up visit.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Adults between age 18 and 60 years old
- •Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions
- •Unwanted tattoo that contains single or multi-color ink, and
- •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
- •Ability to read, understand, and sign the Informed Consent Form
- •Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated
- •Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
排除标准
- •If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics
- •If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months
- •Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments
- •Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study
- •Pregnant or lactating or planning pregnancy before end of study
- •Presence of an active systemic, local skin disease, medication or condition that may affect wound healing or interfere with participation or treatment to the active area.
- •Active or recurrent cancer of current chemotherapy or radiation therapy
- •History of seizure disorders due to light
- •History of vitiligo, eczema, or psoriasis
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
- •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 keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of seizure disorders due to light.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing Any use of medication that is known to increase sensitivity to light according to Investigator's discretion
- •Excessive or recent significant tan in areas to be treated or unable/unlikely to refrain from tanning during the study
- •Current smoker or history of smoking within 3 months of study participation
- •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
- •Any physical or mental condition including alcohol or drug abuse that in the opinion of the investigator could interfere with subject's suitability for inclusion in study
结局指标
主要结局
Investigator's Global Assessment of Improvement
时间窗: Up to 6 Months following final study treatment
Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)
次要结局
- Subject's Global Assessment of Improvement(1 month, 3 Months, 6 Months (Group A Only) post final treatment)
- Subject Satisfaction(1 month, 3 Months, 6 Months (Group A Only) post final treatment)