Clinical Evaluation of the Efficacy and Safety of Novel Drug-free Hyaluronic Acid Topical Nano-carrier in Periocular Rejuvenation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough
研究概览
简要总结
In this study, The investigators aims to evaluate the efficacy and safety of topical hyaluronic acid nanoparticles as a novel nanodermatological tool in periocular rejuvenation as a replacement approach of invasive dermal filler injections.
详细描述
Tear trough deformity is a main concern of many people (males or females) with age range of 21 to 65 years old or older. Such condition is characterized by a sunken appearance of the eye that results in an aged and dissipated appearance to the eye.Treatment modalities range from camouflage make up, laser resurfacing, platelet-rich plasma therapy, carboxy therapy, mesotherapy, volume augmentation with injectable hyaluronic acid fillers and fat, as well as surgical procedures such as blepharoplasty. Consequently, safe, effective and less invasive treatment options of the tear trough have remained a challenge.
The study will include 30 adult patients (male or female) suffering tear trough deformity.
They will be selected from Dermatology Outpatient Clinic of Alexandria Main University Hospital.
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, Investigator)
盲法说明
Double
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy male or female between 21 and 65 years old
- •Is voluntarily willing to consent to participate in the study
- •Is willing to comply with all requirements of the study including being photographed, follow post treatment care instructions, to attend all treatment, and follow up visits
- •Willingness to waive rights to use of still photos of themselves for research, marketing, or promotional reasons, including on the internet and on social media outlets.
- •Willingness to refrain from other surgical, laser, or injectable treatments in the periorbital region during the entire duration of the study.
- •Ability to provide informed consent.
排除标准
- 未提供
研究组 & 干预措施
Hyaluronic acid nanoparticles (2%)
patients with tear trough will receive hyaluronic acid nano-gel (2%) 2 applications / day (morning and evening) on tear troughs for 1 month
干预措施: Hyaluronic acid NanoGel (Drug)
Placebo
patients with tear trough will receive placebo conventional gel having the same color, form and packaging for 1 month
干预措施: Placebo gel (Drug)
结局指标
主要结局
The efficacy of topical hyaluronic acid nanoparticles in treatment of tear trough
时间窗: 1 month
To evaluate the efficacy of topical hyaluronic acid nanoparticles in in treatment of tear trough using Sadick et al scale at baseline and after one month treatment. the score will range from 1-14, in which the higher the score, the worse the outcome
Assessment of improvement of tear trough by topical hyaluronic acid nanoparticles
时间窗: up to 4 weeks
Physician assessment will be done at the one-month follow up visit through blinded evaluator-assessed Global Aesthetic Improvement Score. the score will range from 1-5, in which score 1 is associated with best results and score 5 with worst results.
Patient satisfaction of topical hyaluronic acid nanoparticles in treatment of tear trough
时间窗: 1 month
Patient satisfaction will be assessed using a visual analogue scale which is ranged from 0-3, 0 is associated with least satisfaction and 3 with the best satisfaction.
Incidence of side effects of topical hyaluronic acid nanoparticles around eyes
时间窗: up to 4 weeks
Incidence of side effects will be evaluated at all visits by reporting any adverse events such as erythema, dryness, itching, edema or hyperpigmentation.
次要结局
- The efficacy of topical hyaluronic acid nanoparticles in treatment of dark circles(up to 4 weeks)
研究者
Shimaa Ismail Abdelhamid
Associate professor (MD)
Alexandria University