A Double-blind, Randomized, Controlled Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Clinical Grading of Efficacy Parameters
研究概览
简要总结
This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer. A total of 26 female subjects, aged 34-60, completed study participation.
详细描述
This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer (Cell 2). Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a dull appearance on the global face.
Efficacy and tolerability were assessed through clinical grading at baseline, day 3, and day 7. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and overall photodamage on the global face were performed 15 minutes post product application. Self-assessment questionnaires, Glossymeter measurements, and VISIA photography were completed at baseline, day 3, and day 7.
A total of 26 subjects completed study participation, which included 12 subjects in Cell 1, and 14 subjects in Cell 2.
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 occurred by assignment to either Cell 1 or Cell 2 using a randomization list, prepared by Stephens prior to the start of the study. The list was first created by concatenating blocks of size of 4 subjects, 2 for Cell 1 and 2 for Cell 2. The list was then randomized by variables from 2 independent uniform distributions: one to randomize subjects within a block and one to randomized blocks. After the randomized list was created, treatment was assigned to each subject number accordingly.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 30 to 60 years of age
- •Fitzpatrick skin type I -IV
- •Moderate overall photodamage of the skin
- •Moderate lack of firmness (visual) of the skin
- •Moderate dull appearance of the skin
- •Subjects must be willing to withhold all facial treatments during the course of the study and have not undergone a treatment within the last 6 months
- •Subject must be willing to provide verbal understanding and written informed consent
排除标准
- •Diagnosed with known allergies to facial skincare products
- •Nursing, pregnant, or planning to become during the duration of the study
- •History of skin cancer within the past 5 years
- •Having used oral isotretinoin within the last 12 months
- •Having used prescription-strength skin-lightening products within the last 3 months
- •Having used any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within the last 4 weeks
- •Having a health condition and/or pre-existing or dermatologic disorder that, in the Investigator's opinion, may interfere with the outcome of the study
- •Having observable sunburn, suntan, scars, excessive facial hair, or other dermal conditions on the face that, in the Investigator's opinion, may influence test results
- •Having a history of immunosuppression/immune deficiency disorders, or currently using oral or systemic immunosuppressive medications and biologics, and/or undergoing radiation or chemotherapy
- •Using or having regularly used systemic or topical corticosteroids within the past 4 weeks
- •Having started a long-term medication within the last 2 months
结局指标
主要结局
Clinical Grading of Efficacy Parameters
时间窗: 7 days
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 3, and Day 7 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.
Tolerability Evaluations
时间窗: 7 days
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 3, and Day 7 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
- Irritation Evaluation(7 days)
- Self-assessment Questionnaire(7 days)
- Bioinstrumentation Measurements(7 days)
- VISIA-CR Photography(7 days)