Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change In Clinical Efficacy Parameter Radiance Versus Baseline
研究概览
简要总结
This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.
详细描述
This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 12-weeks days of twice-daily use when compared to the efficacy of a combination of a placebo-control (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, week 4, week 8, and week 12. 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 at baseline and post-baseline by a clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at baseline and week 12 were performed by two board certified dermatologists.
Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects, a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies collected from the lateral, pre-auricular at baseline and week 12.
A total of 62 subjects completed study participation (31 in Cell 1 and 31 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
- Other
- 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 KGL Skin prior to the start of the study.
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
Change In Clinical Efficacy Parameter Radiance Versus Baseline
时间窗: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints. A decrease in scores at post-baseline timepoints (week 4,8, and12) 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.
Change in Active Cell versus Placebo Control in Clinical Efficacy at week 12
时间窗: 12 weeks
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale at post-baseline timepoints versus the placebo control. A confidence interval of 90% (p \<0.10) for both live clinical grading and photo-grading will be performed between the Cell 1 (active comparator) versus Cell 2 (placebo control comparator). 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.
次要结局
- Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline(12 weeks)
- Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline(12 weeks)