A Randomized, Evaluator-Blinded Clinical Study to Evaluate the Efficacy and Tolerability of an Investigational Light Therapy Mask on Subjects With Mild to Moderate Mottled Hyperpigmentation and Moderate to Severe Facial Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
研究概览
简要总结
This research study will test how well a light therapy mask works for women with mild to moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared to a "sham" or inactive investigational light therapy mask. The study will also test if the light therapy mask causes any irritation. For the first 12 weeks of the study, participants will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12 weeks of the study, participants will use just the cleanser and sunscreen.
详细描述
Exposure to sunlight and artificial light sources containing ultraviolet (UV) radiation is known to accelerate the skin's aging process, resulting in unwanted wrinkles, irregular skin tone, and loss of elasticity. Ablative techniques, such as dermabrasion, deep chemical peels, and ablative laser resurfacing of various wavelengths, are well documented to alleviate the signs of photodamage. However, such techniques often require significant post-treatment care and have higher risk profiles than other treatments, with potential side effects including erythema, pigmentation issues, infection, and possible scarring. They may be poorly tolerated by patients who dislike the discomfort, wound care, and prolonged downtime involved.
Non-ablative skin rejuvenation procedures are also effective for improving the appearance of photodamaged skin and are becoming increasingly popular because of their minimal downtime and increased safety. These procedures include intense pulsed light systems, non-ablative lasers, and monochromatic light boxes, which can target facial rhytids, irregular pigmentation, telangiectasia, and skin laxity. Unfortunately, such techniques can be expensive and their use is primarily limited to clinical settings.
However, the light-emitting diode (LED) is a novel light source that is well-suited for non-ablative phototherapy that can be utilized at home for a relatively low price. This study will evaluate the efficacy and tolerance of an LED-based light therapy mask as compared to a sham mask in subjects seeking anti-aging benefits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has mild to moderate brown spots
- •Has moderate to severe facial wrinkling
- •Able to read, write, speak, and understand English
- •In general good health
- •If capable of having a child: must agree to practice a medically acceptable form of birth control.
- •Intends to complete the study and willing to follow all study directions.
排除标准
- •Allergies/sensitivity to skincare products or the test product ingredients
- •Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results.
- •Is taking medication that may cause skin sensitivity to light
- •Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
- •Has a facial skin condition (e.g. rosacea, acne, eczema, etc.) that could increase health risk to the subject or confuse the study results.
- •Has skin cancer or a history of skin cancer.
- •Has an immune deficiency disorder, active hepatitis, or an autoimmune disease.
- •Has an uncontrolled metabolic condition (e.g. diabetes, hypertension)
- •Is pregnant, nursing, or planning to become pregnant.
- •Plans to start or change a hormone replacement therapy during the study.
- •Has participated in another study in the past 30 days or plans to during the study.
- •Is an employee or relative of the Study Site, Investigator, or Sponsor.
结局指标
主要结局
Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
时间窗: Baseline to Week 12
3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2
时间窗: Baseline to Week 12
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1
时间窗: Baseline to Week 12
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.
Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3
时间窗: Baseline to Week 12
Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.
次要结局
- Fine Lines - Change From Baseline to Week 12(Baseline to Week 12)
- Fine Lines - Change From Baseline to Week 24(Baseline to Week 24)
- Global Wrinkling - Change From Baseline to Week 1(Baseline to Week 1)
- Fine Lines - Change From Baseline to Week 1(1 week)
- Periorbital Wrinkles - Change From Baseline to Week 1(Baseline to Week 1)
- Periorbital Wrinkles - Change From Baseline to Week 4(Baseline to Week 4)
- Periorbital Wrinkles - Change From Baseline to Week 12(Baseline to Week 12)
- Lack of Radiance - Change From Baseline to Week 4(Baseline to Week 4)
- Global Wrinkling - Change From Baseline to Week 4(Baseline to Week 4)
- Surface Roughness - Change From Baseline to Week 12(Baseline to Week 12)
- Global Wrinkling - Change From Baseline to Week 24(Baseline to Week 24)
- Fine Lines - Change From Baseline to Week 4(Baseline to Week 4)
- Surface Roughness - Change From Baseline to Week 4(Baseline to Week 4)
- Surface Roughness - Change From Baseline to Week 24(Week 24)
- Uneven Skin Tone - Change From Baseline to Week 1(Baseline to Week 1)
- Mottled Hyperpigmentation - Change From Baseline to Week 1(Baseline to Week 1)
- Mottled Hyperpigmentation - Change From Baseline to Week 12(Baseline to Week 12)
- Lack of Radiance - Change From Baseline to Week 1(Baseline to Week 1)
- Periorbital Wrinkles - Change From Baseline to Week 24(Baseline to Week 24)
- Uneven Skin Tone - Change From Baseline to Week 12(Baseline to Week 12)
- Lack of Radiance - Change From Baseline to Week 12(Baseline to Week 12)
- Lack of Radiance - Change From Baseline to Week 24(Baseline to Week 24)
- Surface Roughness - Change From Baseline to Week 1(Baseline to Week 1)
- Uneven Skin Tone - Change From Baseline to Week 4(Baseline to Week 4)
- Sallowness/Yellowing - Change From Baseline to Week 4(Baseline to Week 4)
- Sallowness/Yellowing - Change From Baseline to Week 12(Baseline to Week 12)
- Uneven Skin Tone - Change From Baseline to Week 24(Baseline to Week 24)
- Mottled Hyperpigmentation - Change From Baseline to Week 4(Baseline to Week 4)
- Mottled Hyperpigmentation - Change From Baseline to Week 24(Baseline to Week 24)
- Sallowness/Yellowing - Change From Baseline to Week 1(Baseline to Week 1)
- Sallowness/Yellowing - Change From Baseline to Week 24(Baseline to Week 24)