Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin elasticity measured with Cutometer
研究概览
简要总结
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
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
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and 60 years (inclusive)
- •The presence of visible signs of skin aging, mainly dry neck skin, rough neck skin, loss of elasticity and clear lines and wrinkles (grades 2, 3, and 4 based on the IBSA Neck Laxity Scale)
- •Able to follow study instructions and likely to complete all required visits
- •Signing the informed consent form and agreeing to the 6-month follow-up
排除标准
- •Previous treatment with fillers containing hyaluronic acid in the neck area during the last year
- •History of using RF, rejuvenating lasers or intense pulsed light in the last 6 months
- •Having systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, liver and kidney failure.
- •History of systemic use of drugs affecting the skin such as glucocorticoids, isotretinoin, immunomodulators and hormonal drugs in the last 3 months
- •History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months
- •History of using topical corticosteroids and retinoids in the last 4 weeks
- •Using topical cosmetic products containing anti-aging ingredients in the last 2 weeks
- •Pregnant and lactating women
- •History of active smoking during the last 2 years
- •Major change in lifestyle including diet and physical activities and sun exposure during the study
- •History of previous allergy to hyaluronic acid or lidocaine
- •Any inflammation, active infection, unhealed old wound, and skin lesions in the injection area
- •Using any anticoagulant product, NSAID, or any other drug that increases the risk of coagulation disorders, in the last 7 days
- •History of anaphylactic shock
- •Being prone to hypertrophic scar formation
- •History of autoimmune disease or immune deficiency or using immunosuppressant drugs
研究组 & 干预措施
Perleux body
干预措施: Hyaluronic Acid (HA) (Device)
结局指标
主要结局
Skin elasticity measured with Cutometer
时间窗: weeks 8 and 16
Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit
次要结局
- Stratum corneum moisture(weeks 8 and 16)
- Transepidermal Water Loss (TEWL)(weeks 8 and 16)
- General neck condition(weeks 8 and 16)
- Skin aging(weeks 8 and 16)
- Pain intensity(Day 0 and week 4)
- Participant satisfaction(weeks 8 and 16)
- Participant evaluation(weeks 8 and 16)
- Safety assessment(Day 0 and weeks 4, 8, 16)