NCT06117293招募中不适用
Safety and Efficacy Evaluation of the Mosaic Ultra Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Photographic Assessment
研究概览
简要总结
Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking, Male or Female
- •Age 18 - 60 years old
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
- •Participants who are 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.
- •OPTIONAL - Participants who are willing to undergo biopsies.
排除标准
- •Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure
- •A study participant must not be pregnant or have been pregnant in the last 3 months
- •A recent history of smoking (6 months)
- •Presence of an active skin disease or condition that may affect wound healing (ie. diabetes myelitis; connective tissue disease; radiation therapy; or chemotherapy)
- •Seizure disorder caused by bright light
- •A history of thrombophlebitis
- •A history of acute infections
- •A history of heart failure
- •Cancer, malignant disease, skin pathology, condition, or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during, or after treatments
- •Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E, or anti-inflammatories within 2 weeks prior to treatment
- •Intolerance or allergy to medications that could be prescribed before or after the procedure (eg, antibiotics, anesthesia)
- •A history of keloids
- •A history or evidence of poor wound healing
- •A history of coagulative disorder or current use of anticoagulant drugs within 2 weeks of study participation
- •Use of steroids within 2 weeks of study treatments
- •Patients with implanted pacemaker or defibrillator, or metal pins, or prosthetic joints within 4 cm of treatment area
- •History of psychoneurosis and/or a history of alcohol or drug abuse
结局指标
主要结局
Photographic Assessment
时间窗: 90-day Follow-Up
Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators
次要结局
- Safety Assessment(up to 90 days post final treatment)
- Physician Satisfaction(30-day and 90-day Follow-Up)
- Physician Clinical Global Aesthetic Improvement Scale(30-day and 90-day Follow-Up)
- Coagulation Zone Measurements(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Tissue Reepithelization(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Subject Satisfaction(30-day and 90-day Follow-Up)
- Subject Clinical Global Aesthetic Improvement Scale(30-day and 90-day Follow-Up)
- Epidermal Inflammatory Response(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
- Dermal Inflammatory Response(Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post)
研究者
研究点 (6)
Loading locations...
相似试验
尚未招募
不适用
Laser Treatment for Facial and Neck RejuvenationFace RejuvenationNeck RejuvenationNCT05808842Goldman, Butterwick, Fitzpatrick and Groff15
招募中
4 期
Efficacy and Safety of using microfocused ultrasound with circular cartridge for enlarged pores in ThailandEnlarged poresmicro-focused ultrasoundcircular cartridgeTCTR20230417003Faculty of Medicine Siriraj Hospital, Mahidol University32
招募中
4 期
Efficacy and Safety of using microfocused ultrasound with circular cartridge for upper face laxity in Thailandpper facial laxitymicro-focused ultrasoundlaxitybrow liftingTCTR20230418001Faculty of Medicine Siriraj Hospital, Mahidol University37
招募中
4 期
Efficacy and Safety of using microfocused ultrasound with circular cartridge for lower face sagging in Thailand; A pilot studyower face saggingSaggingLower facemicro-focused ultrasoundDouble chinTCTR20230418006Faculty of Medicine Siriraj Hospital, Mahidol University25
招募中
不适用
Clinical efficacy and safety of an ultrasound apparatus T-75 in the treatment of patients with ischemic heart diseaseAngina pectorisJPRN-UMIN000012369Tohoku University80