RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin: a Prospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in wrinkles
研究概览
简要总结
The appearance of the aging skin is influenced by different factors including by the reduced elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation disorders and dilated vascular markings. Currently, there are different methods available to treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN) and thulium laser has been commonly used in clinical practice.
The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety of RFMN and thulium laser treatment in patients with facial, age-related skin laxity, wrinkles, and pigmented lesions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from the age of 30 years
- •good general condition, no relevant previous diseases
- •Presence of wrinkles, dermatochalasis on the face, pigment spots, which are an indication for RFMN and thulium laser or comparable methods
- •Cognitive ability and willingness to give consent (informed consent)
- •Be willing and able to attend follow-up visits
排除标准
- •Age < 30 years
- •Pregnancy or breastfeeding
- •Excessive subcutaneous fatty tissue under the cheeks
- •Significant scarring of the region to be treated
- •open wounds or lesions of the region to be treated
- •Severe or cystic facial acne
- •Metallic implants in the face or neck region
- •Mental illnesses (psychoses, body perception disorders)
- •Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
- •Fillers in the region to be treated < 4 weeks prior and during the study period
- •Resurfacing (fractional, ablative, nonablative) of the region of interest < 2 months prior and during the study period
- •Plastic aesthetic procedures or other surgical procedures < 6 months prior and during the study period
- •Tendency to have excessive scarring
- •Lack of informed consent
结局指标
主要结局
Change in wrinkles
时间窗: 6 months after last treatment session
software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)
Change in pigmentation
时间窗: 6 months after last treatment session
software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)
Change in volume
时间窗: 6 months after last treatment session
software-assisted evaluation of volume (Vectra(R) Software, Canfield)
次要结局
- Adverse Events(before every treatment session, at every follow-up visit (3 and 6 months post-treatment))
- Pain intensity(10 minutes after starting each treatment session, one treatment session takes 30-50 minutes)
- Withdrawals due to AE(before every treatment session, at every follow-up visit (3 and 6 months post-treatment))
研究者
Lynhda Nguyen
Principle Investigator
Universitätsklinikum Hamburg-Eppendorf