Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
详细描述
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes.
Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age or older
- •Fitzpatrick skin type I-VI
- •Willingness to provide signed, informed consent to participate in the study
- •Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
- •Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
- •Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
- •Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.
排除标准
- •Pregnant or planning to become pregnant, or breast feeding during the study
- •Skin cancer in the treatment area or history of melanoma in the treatment area
- •History of current cancer and subject has undergone chemotherapy within the last 12 months
- •Severe concurrent conditions, such as cardiac disorders, per investigator discretion
- •Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
- •Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- •Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
- •Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device
- •Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds as per discretion of the investigator
- •History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin as per discretion of the investigator
- •History of collagen vascular disease or vasculitic disorders as per discretion of the investigator
- •Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
- •History of systemic corticosteroid therapy in past six months as per discretion of the investigator
- •Tattoos or permanent makeup in the intended treatment area unless to be treated for tattoos or permanent makeup
- •If to be treated for efficacy assessments, history of aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area, neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months, permanent synthetic fillers (e.g. silicone) in the treatment area, absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area, or surgery within the intended treatment area. History of prior treatments and procedures will be assessed per investigator discretion.
- •In the opinion of the investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: From the first treatment to the last treatment, up 132 weeks.
Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated.
Post-treatment Assessment Severity Scale
时间窗: From the first treatment to the last treatment, up to 132 weeks.
Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe.
次要结局
未报告次要终点