An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline
研究概览
简要总结
This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.
详细描述
This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.
Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.
A total of 42 subjects completed the study.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 35 and 65 years
- •Women with Fitzpatrick skin type I-VI
- •Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
- •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
- •Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
- •Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
- •Subjects that are unwilling to comply with the protocol
- •Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- •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.
结局指标
主要结局
Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline
时间窗: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 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.
Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline
时间窗: 12 weeks
The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 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
- Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline(12 weeks)
- Stable skin pH during 12 week study(12 weeks)
- Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline(12 weeks)
- Improvement in Epidermal Thickness after 12 weeks versus baseline(12 weeks)