Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Improvement of anti-aging parameters
研究概览
简要总结
Main objective : To evaluate the anti-aging effectiveness of the LED mask alone on at least one studied anti-aging parameters (including some targeted wrinkles) after 3 months versus baseline
Secondary objectives:
- Anti-aging clinical score (radiance, skin tone, fine line, ptose, plumpness, ..)
- Evaluate the consumer perception (self-evaluation)
- Tolerance
- Standardized pictures (all light) and pictures analysis
- Comparison of effectiveness between the 2 groups (with and without formula
详细描述
Rational Photodamaged/aged facial skin is characterized by thinner and drier skin, with increasing sags and wrinkles due to the loss of collagen and elastic tissue. Aging skin is also much more susceptible to the development of brown spots and pigmentation.
The use of LED masks to combat skin aging is based on a scientific principle called photobiomodulation. Red and near-infrared light stimulates cellular repair mechanisms without heating or damaging tissues. Its safety profile is well-documented across all skin types and side effects of phototherapy have been shown as being minimal and temporary.
Design:
Prospective, monocentric, open, non-randomized study conducted in healthy female participant aged 35 to 60 years.
The clinical investigation is design to evaluate the efficacy and tolerability of a LED mask with or without a serum formula on the anti-aging signs of the face.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged between 35-60y.o
- •Presenting all skin types
- •Presenting all phototype according to Fitzpatrick Classification
- •Sensitive skin (50%) - declarative
- •Daily user of SPF30 or 50+ for at least 30 days
- •User or not of LED masks (collected data)
- •Mask adapted to the shape of the face
- •Having mild to moderate scores (as indicated) for the items parameters
- •Subjects willing not to change their face/eyes make-up removal products and habits, and shower habits (e.g. shampoo, shower gel), and make-up products (eyes and mouth) throughout the course of the study.
- •Subjects willing to use the investigational devices and/or products on the face throughout the course of the study period
- •Subjects taking an effective oral contraception or other methods of contraception for the duration of the study
- •Written Informed Consent Form to participate in the study
- •illingness and ability to comply with protocol requirements
排除标准
- •Subjects having allergy or sensitivity to LED Light
- •Subjects having at risk of epilepsy
- •subject who may have headaches
- •Subjects having participated in the clinical study using anti-aging formula on the face within at least 3 months preceding the baseline visit
- •Subjects having used any cosmetic products with exfoliating or astringing allegation on the face within at least 4 weeks preceding the baseline visit
- •Subject with arterial circulatory disorders in the treated area,
- •Subjects with sensitivity troubles and pain perception impairment, facial paralysis,
- •Subjects with degenerative and vascular retinal disease,
- •Subjects with known problems of scarring or wound healing,
- •History of photosensitivity or photo allergy
- •History of chronic viral infections (herpes simplex, ZONA…) and last outbreak within 12 months preceding the baseline visit
- •Subject having an underlying dermatological disease or conditions on the face, which in the investigator's opinion, could interfere with study evaluation
- •Subjects with a melanoma history in the family (parents or grandparents)
- •Subjects undergone the radiotherapy in the treated areas,
- •Subject having excessive moles, excessive pigmented spots, tattoos, scars, irritated skin, etc. at the test area that could influence the investigation
- •Subject with a history of surgery to the treatment concerned areas within 6 months preceding the baseline visit
- •Subject reports (or plans to) sunbath or overexpose to UV-light (mountains sports, phototherapy, tanning salon use…) for aesthetic or therapeutic reason one month before the study start (or during the study).
- •Subject having modified their cosmetic habits (moisturizing skin care, cleansers, make-up removers, make-up, shower products, shampoo…) during the 2 weeks before baseline visit.
- •Subject uses or has used any of the medications or topical treatments/skincare products/procedure below without relevant wash-out period before the baseline visit (or is unwilling or unable to accept to follow the wash-out period below during the study)
研究组 & 干预措施
ARM 1 : MASK LED ALONE
Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)
干预措施: MASK LED (Device)
ARM2 : DEVICE + COSMETIC FORMULA
Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)
干预措施: LED MASK AND COSMETIC FORMULA (Combination Product)
结局指标
主要结局
Improvement of anti-aging parameters
时间窗: baseline to 3 months
The expert clinical grading will perform a standartied clinical evaluation oth the 14 anti-aging items with the scale 10 grade -point scale (0-9) or L'Oréal Skin Aging Atlas (scale photonumeric)
次要结局
- Global tolerance(Immediate time to 3 months)
- Self assessment questionnaire(immediat time to 3 months)