Impact of Tripolar Radiofrequency on Acne Scar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessing the change in severity of acne scars
研究概览
简要总结
The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar
详细描述
Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).
There are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).
Furth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old
- •Both genders will participate in this study as the following distribution 17 male and 23 female.
- •They diagnosed as acne scar by their physicians and referred for physical therapy management.
- •Medically and psychologically stable patients.
- •All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients
排除标准
- •Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).
- •Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
- •Medically unstable and uncooperative patients.
- •Untreated and active/ongoing acne vulgaris.
- •Immunocompromised status.
- •History of skin cancer.
- •Recurrent herpes viral infection.
- •Pregnancy or breastfeeding status.
- •Females take contraceptive pills
- •Hormonal disturbance
研究组 & 干预措施
Group A
Consists of 20 patients with acne scars and will receive medical treatment by a dermatologist and tripolar radiofrequency (RF) therapy once a week for 12 weeks, each session for 15 minutes.
干预措施: Tripolar radiofrequency therapy (Device)
Group A
Consists of 20 patients with acne scars and will receive medical treatment by a dermatologist and tripolar radiofrequency (RF) therapy once a week for 12 weeks, each session for 15 minutes.
干预措施: medical treatment (Drug)
Group B
consists of 20 patients with acne scars and will receive medical treatment by a dermatologist
干预措施: medical treatment (Drug)
结局指标
主要结局
Assessing the change in severity of acne scars
时间窗: at base line and following 12 weeks
SCARS is a 5-item instrument designed to rate the severity of acne scars in a mirror. It uses visual analog scales to differentiate between active and scars. The tool is self-completion and can be completed quickly. Patients are photographed at the beginning and after 12 treatment sessions. SCARS scores range from 0 to 4, with higher scores indicating greater severity. It captures demographic information and clinical characteristics of acne and scarring.
次要结局
- Assessing the quantitative measurement of the acne scars(at base line and following 12 weeks)
研究者
Alshymaa Ahmed Kamel Ahmed
Principal Investigator
Cairo University