Effect of Photobiomodulation Associated With Polydioxanone Thread in the Treatment of Glabellar Wrinkles: Clinical, Randomized, Controled, Double Blind Trial
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
- Edema assessed by Ultrasound
研究概览
简要总结
Physical appearance is a factor that contributes to an individual's self-esteem. Maintaining a healthy appearance is a growing quest by the population, and aging is the main cause of discomfort for men and women. There are several aesthetic treatments capable of mitigating or delaying the effects of aging in all its layers of alteration (dermis, hypodermis, musculature and bone), and the combination of therapies has been increasingly proposed in search of a positive synergy. The dermal application of polydioxanone threads (PDO) and the low-power red LED (photobiomodulation - PBM) are individual options of resources for which there already are reports in the literature about their mechanisms of action in the proliferation of fibroblasts and collagen production. However, the joint application of these techniques requires further studies.
A total of 40 patients, aged between 30 and 60 years old, phototypes I-IV in Fitzpatrick scale, Glogau 3-4, presenting static wrinkle at the glabellar region will be recruited and distributed among 2 groups: PDO thread + PBM or PDO thread + sham PBM. The treatments will consist of 30 days, with one application of PDO thread and PBM twice a week (total of 9 sessions).
详细描述
This is a controled, randomized, double blind, two arms clinical trial. The main objective of this study is to evaluate the effect of PBM with red light associated to PDO threads in individuals with static wrinkles in the glabellar region in terms of oedema, dermal thickening and PDO thread hydrolysis.
The sample will be divided into 2 groups: Group 1 will receive PDO thread and PBM with Red LED (Newskin, MMO), 150 milliwatt (mW), 2 Joule (J) per point, 4 J/cm² , 10 points per session, Group 2 will receive PDO thread and PBM sham. A total of 40 patients with glabellar wrinkle, aged 30 to 60 will be included. The treatments will consist of 9 sessions, twice a week for 30 days. The oedema and dermal thickness will be evaluated by linear ultrasound (10-14 MegaHertz (MHz), Mobisson). Photographic records will also be made.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both genders
- •aged between 30 and 60 years,
- •Fitzpatrick skin phototype I - IV,
- •levels 3 and 4 in the aging classification according to Glogau,
- •presenting glabellar static wrinkles (permanent wrinkles)
- •who do not have uncompensated comorbidities.
排除标准
- •decompensated diabetes, lupus, HIV positive, hepatitis, high blood pressure, neurological disorders, active neoplasms,
- •tendency to develop keloids,
- •menopause, pregnant women,
- •participants who have absorbable threads (applied less than 3 months ago) or definitive at glabella,
- •who have PMMA (polymethylmethacrylate) application in any region of the face,
- •who are undergoing treatment with any type of laser therapy in any areas of the body,
- •participants who are undergoing aesthetic or dermatological treatment on the face,
- •participants who are using anti-inflammatories and corticoids in a window of 30 days before and after the procedure,
- •participants using isotretinoin in the last 6 months.
结局指标
主要结局
Edema assessed by Ultrasound
时间窗: 24 hours after PDO thread application (day 1)
Ultrasound transversal measurement from epidermis to the beginning of muscle tissue.
次要结局
- dermis thickness(day 90)
- PDO thread hydrolysis(day 180)
- Photos(day 180)
研究者
Christiane Pavani
Clinical Professor
University of Nove de Julho