Skin Aging Clinical Trial
Official title:
A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin
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.
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.
In this study, subjects are subject to a 4-week washout period before using P29429-01 on full
face twice a day for 12-week. A skin analyzer is used to obtain skin aging indices to assess
the efficacy and safety of P29429-01.
Study Purpose:
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 who show manifestations of
facial skin aging. Subjects are to undergo a 4-week washout period before using P29429-01 on
the face for 12 weeks. A skin analyzer is used to obtain skin aging indices for said
assessment.
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