A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Clinical Efficacy Graded by Griffiths' Scale
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
详细描述
This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.
Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.
A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
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
Randomization will occur by assignment to either the active group or placebo group using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the investigator. Subjects will be assigned a number in numerical order as enrolled. The unblinded staff member will take a set of products from one of two groups of labeled active product vs. placebo and fill in the patient number and distribution date on the bottles to be dispensed to the subject.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
- •Women with Fitzpatrick Skin Type I-VI
- •Subjects must have mild to moderate global face wrinkles and fine lines
- •Subjects may have mild to moderate photo-aging secondary to physiologic aging
- •Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects must be willing to provide verbal understanding and written informed consent.
排除标准
- •Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- •Subjects with severe overall photo damage as determined by the Investigator.
- •Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
- •Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- •Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
- •Subjects who spend excessive time out in the sun.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
结局指标
主要结局
Clinical Efficacy Graded by Griffiths' Scale
时间窗: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 in comparison to baseline indicates an improvement for the indicated parameter.The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome.
Objective Tolerability: scores
时间窗: 12 weeks
The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at Day 28, Day 56 and Day 84 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema:Erythema 0 = None No erythema of the treatment area 1. = Mild Slight, but definite redness of the treatment area 2. = Moderate Definite redness of the treatment area 3. = Severe Marked redness of the treatment area
次要结局
- Subjective Tolerability: scores(12 weeks)
- Self Assessment Questions(12 weeks)