CTRI/2012/01/002325已完成不适用
A single-center, randomized, controlled study to evaluate the safety and effectiveness of the electro muscular stimulation device to improve skin elasticity, firmness and to reduce the signs of facial aging in healthy adults after 10 weeks of product use
Vercel Inc1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To improve muscle toning, skin elasticity, firmness, fine line & wrinkle reduction and to reduce the signs of facial aging in healthy adults
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the electro muscular stimulation device to improve muscle toning, skin elasticity, firmness, fine line & wrinkle reduction and to reduce the signs of facial aging in healthy adults after 10 weeks of product use. This will be a single-center study, randomized, controlled study consisting of 30 healthy adults in test group and 30 healthy subjects in control group between 35 to 50 years of age, meeting the eligibility criteria. Subjects will be allocated in two groups Group - A & Group - B. Subjects in Group - A will receive study product (Electronic Muscle Stimulator) and basic cream(Pond’s cream) Subjects in Group - B will receive only basic cream (Pond’s cream)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Month(s)（—）
- 性别
- All
入选标准
- •50 years of age.( 40% male and 60% female ) 2.Visual signs of aging on the face with mild/moderate to severe wrinkles. 3.In general good health, •Free of dermatological conditions such as eczema, seborrheic dermatitis and psoriasis. 4.Signing of an Informed Consent Contract in conformance with CFR Part 50: "Protection of Human Subjects". 5.Dependability and intelligence in following directions. 6.Completion of a Panelist Profile/Medical History. 7.Subjects must be willing to maintain their normal diet throughout the duration of the study. 8.Using acceptable methods of birth control.
排除标准
- •1.Pregnant women (or pregnancy within last 3 months).
- •2.Inadequate precaution or procedure to prevent pregnancy (women of child- bearing potential only).
- •3.Treatment for any type of cancer within the last six months.
- •4.Use of any prescribed anti-inflammatory drug, immunosuppressive drugs or antihistamine medication (steroid nose drops and/or eye drops are permitted).
- •5.Damaged skin in or around test sites which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfiguration of the test site.
- •6.Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.).
- •7.Current or history of a medical condition that would contraindicate treatment with the product, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditions which, in the opinion of the Investigator, would place the participant at risk.
- •8.A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis, burns, abrasions, etc.) 9.Heavy alcohol consumption in the opinion of the investigator.
- •10.A fever in the last 12 hours prior to the first application of the test device.
- •11.History of heart disease.
- •12.History of stroke.
- •13.History of malignant disease.
- •14.Insulin dependent diabetes.
- •15.Concurrent medication likely to affect the response to the test article or confuse the results of the study (e.g. routine high dose use of any drugs that may artificially affect skin tone).
- •16.Individuals who are currently participating in any other clinical.
- •Investigation, or who have participated in a study with the same indication within 1 year.
- •17.Principal investigator for this study, or member of study staff.
- •18.Participants with skin conditions such as obvious sun damage, increased pigmentation and / or telangectasia.
- •19.Any dental inflammation or other acute dental condition.
- •20.Individuals who have had facial surgery.
- •21.Patients with facial muscle fever.
结局指标
主要结局
To improve muscle toning, skin elasticity, firmness, fine line & wrinkle reduction and to reduce the signs of facial aging in healthy adults
时间窗: 10 weeks after product use
次要结局
未报告次要终点
研究者
研究点 (1)
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