Clinical Study on 56-Day Continuous Improvement of 1064nm Fractional Picosecond Laser Treatment With Formulations of A Proprietary Anti-aging Complex Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- changes in skin manifestations of photodamage (tactile skin roughness)
研究概览
简要总结
This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.
详细描述
The main expectations are:
- After the 8-week continuous use of the test formulations with MLYAAT-1002® on one split-face side, the clinical manifestations and scores of photoaging improve compared to those of the control side using the placebo formulations.
- After the 8-week continuous use of the test formulations with MLYAAT-1002®, indicators of skin tone, individual type angle (ITA), CIELAB color space, pores and wrinkles improve compared to those of the control side using the placebo formulations.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •self-reported facial aging problems such as roughness, fine lines, and dull skin
- •no symptoms of itching, tingling, or burning on the face
- •no symptoms of facial flushing, erythema, papules, desquamation, or spot haemorrhage as evaluated by a dermatologist
- •photodamage scores above 2 (evaluated by a dermatologist)
- •compliance with split-face use of the assigned formulations for 56 days
- •no antibiotics remedy in the past three months
- •regular use of sunscreen products at least five times a week
- •no plans to leave Shanghai during the period of the trial
- •compliance with no use of any cosmetics that may bias the study results during the period of the trial
- •written informed consent and portrait right consent were obtained from all participants before study entry
排除标准
- •female subjects who are pregnant, lactating or planning to become pregnant
- •history of alcoholism
- •history of allergies
- •subjects who have received medical rejuvenation treatment within the past one year
- •being a participant in any other clinical trial within the past one month
- •subjects who are suffering from facial skin diseases (melasma, acne, and herpes simplex, etc.)
- •subjects with scar constitution or that predispose to Koebner's phenomenon (such as vitiligo and lichen planus, etc.)
- •subjects who had skin diseases (such as psoriasis, eczema, and skin cancer, etc.)
- •taken/injected anti-allergy medication in the past one month
- •subjects who had a high fever in the past 2 weeks
- •received anticancer chemotherapy or immunotherapy in the past 6 months
- •anyone that the investigator thinks of not eligible.
结局指标
主要结局
changes in skin manifestations of photodamage (tactile skin roughness)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a roughness score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (global score)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a global score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (fine lines)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a fine-line score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (coarse wrinkles)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a coarse-wrinkle score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (mottled pigmentation)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a pigmentation score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (telangiectasia)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a telangiectasia score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (erythema)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, an erythema score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
changes in skin manifestations of photodamage (dull skin)
时间窗: Day 0, Day 15, Day 29, Day 57
Scoring by two independent dermatologists, a dull-skin score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.
次要结局
- changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin(Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in index of melanin of facial skin(Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in individual typology angle (ITA°) of facial skin(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in skin surface hydration(a.u.) of facial skin(Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in index of erythema of facial skin(Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in the characteristics of facial wrinkles(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- self-assessment by participants(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- safety and tolerability(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in the percentage of facial skin pore area(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in the characteristics of facial wrinkles （depth)(Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57)
- changes in the characteristics of crow's feet(Day 0, Day 29, Day 57)