A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Facial skin hydration change from baseline
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of P29429-01 as a skin care product to manage skin aging in women subjects 40-65 years of age.
详细描述
Background and Rationale:
Skin aging, a major concern for females, is closely associated with factors including genetics, age and UV exposure.
Its first signs include reduced epidermal and dermal thickness, reduced water content in the stratum corneum causing the "dry look" of skin.
The ability of dermal fibroblasts to synthesize collagen fibers is reduced bring the decreased collagen content, and the intradermal elastic fibers are denatured and lose elasticity. The extracellular matrix of the dermis, such as hyaluronic acid, are also decreasing year by year.
These are the primary causes of wrinkle formation, loosening and drooping. The anti-aging product used in this study, P29429-01, is developed and manufactured by Orient EuroPharma. Its main ingredients include Hesperetin, a citrus bioflavonoid of antioxidant activity extracted from citrus peel. It is widely used in cosmetic products. Sodium cyclic lysophosphatidic acid, a substance extracted from soybean, increases hyaluronic acid and collagen synthesis in the skin to achieve hydration and anti-aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 40~65 years of age;
- •Subjects are not found with facial skin tissue changes or inflammation as determined by the investigator ;
- •Has skin aging of Glogau class II, i.e. presence of wrinkles during facial movement or resting, as determined by the investigator;
- •The subject is able to understand and comply with the requirements, instructions and restrictions specified in the protocol; and
- •Sign on the informed consent form.
排除标准
- •Received active facial treatment including laser, pulse light, CPT Thermage, HIFU lifting or subcutaneous filler injection in the last 6 months;
- •Has history of chronic skin condition or autoimmune disorders such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea or keloid;
- •Has history of allergy to the study skin care product (P29429-01) compositions, moisturizer or sunscreen;
- •Pregnant or breastfeeding women;
- •Received hormone medications such as estrogen or progesterone, or health foods such as royal jelly, soybean isoflavone, red clover, black cohosh, Chinese Angelica, evening primrose oil, borage oil, chasteberry or placenta extract within 30 days before the study;
- •Required treatment for any acute condition or infection within 14 days before the study;
- •Experienced a serious medical condition such as disease of the heart, lungs, brain and/or liver within 3 months before the study;
- •Has been a routine smoker within 12 months before the study;
- •Currently has malignant tumor;
- •Has used any medicine for skin use on the face that is deemed to interfere with the study within 30 days before the study by investigator;
- •Has participated in another clinical trial within 30 days before the study;
- •Receiving medical management that may affect the ability to participate in this study;
- •Inappropriate for participating in this study as deemed by the principal investigator.
- •Inclusion Criteria for Substudy:
- •Has provided written informed consent for the main study;
- •Subjects are not found with tissue changes or inflammation at the planned biopsy site on medial forearm skin as determined by the principal investigator or dermatologist;
- •The subject is able to understand and comply with the requirements, instructions and restrictions specified in the substudy;
- •Sign and date on the informed consent form of the substudy.
- •Exclusion Criteria for Substudy:
- •Currently using anticoagulants;
- •Patients with severe coagulation disorder;
- •Patients with keloid predisposition.
研究组 & 干预措施
Primary Subjects
Women subjects 40-65 years of age that meet the specified inclusion/exclusion criteria taking P29429-01 as a skin care product per the protocol.
干预措施: Anti-Aging Skin Care product (Other)
结局指标
主要结局
Facial skin hydration change from baseline
时间窗: Week 12
Corneum hydration of the skin will be determined using CK's Corneometry
Facial skin elasticity change from baseline
时间窗: Week 12
Elasticity of the skin will be determined using CK's Cutometer.
次要结局
- Facial texture change from baseline(Week 12)
- Study compliance of the subjects(Week-4~12)
- Facial wrinkles change from baseline(Week 12)
- Facial brown spots change from baseline(Week 12)
- Facial red area change from baseline(Week 12)
- Facial UV spots change from baseline(Week 12)
- Sebumeter values change from baseline(Week 12)
- Facial skin wrinkles change from baseline(Week 12)
- Facial spots change from baseline(Week 12)
- Transepidermal water loss (TEWL) by tewameter change from baseline(Week 12)
- Assess the safety of P29429-01 as a skin care product(Week 1~12)
- Facial pores change from baseline(Week 12)
- Mexameter values change from baseline(Week 12)
- Facial skin texture change from baseline(Week 12)
- The effect of P29429-01 in increasing hyaluronic acid, collagen and elastic fiber using skin tissue biopsy(At week -1 and Week 12)
- Facial skin melanin values change from baseline(Week 12)
- Facial skin hemoglobin values change from baseline(Week 12)
- Assess the safety of P29429-01 as a skin care product with skin health questionnaires(Week 1~12)
- Facial porphyrin (from Propionibacterium acnes) change from baseline(Week 12)
- Assess P29429-01 satisfaction of the subjects with satisfaction questionnaires(Week 1~12)
- Facial skin pore change from baseline(Week 12)
- Facial skin depression/elevation change from baseline(Week 12)