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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week.
National Taiwan University Hosptal
Taipei, Taiwan
Facial skin hydration change from baseline
Corneum hydration of the skin will be determined using CK's Corneometry
Time frame: Week 12
Facial skin elasticity change from baseline
Elasticity of the skin will be determined using CK's Cutometer.
Time frame: Week 12
Facial spots change from baseline
Assess facial skin spots with VISIA advanced skin tester.
Time frame: Week 12
Facial pores change from baseline
Assess pore size with VISIA advanced skin tester.
Time frame: Week 12
Facial wrinkles change from baseline
Assess wrinkles with VISIA advanced skin tester.
Time frame: Week 12
Facial texture change from baseline
Assess texture with VISIA advanced skin tester.
Time frame: Week 12
Facial porphyrin (from Propionibacterium acnes) change from baseline
Assess porphyrin values with VISIA advanced skin tester.
Time frame: Week 12
Facial brown spots change from baseline
Assess brown spots with VISIA advanced skin tester.
Time frame: Week 12
Facial red area change from baseline
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Assess red area with VISIA advanced skin tester.
Time frame: Week 12
Facial UV spots change from baseline
Assess UV spots with VISIA advanced skin tester.
Time frame: Week 12
Sebumeter values change from baseline
Measure sebum (oil) on the skin with CK skin tester.
Time frame: Week 12
Mexameter values change from baseline
Measure melanin content on the skin with CK skin tester.
Time frame: Week 12
Transepidermal water loss (TEWL) by tewameter change from baseline
Transepidermal water loss (TEWL) with CK skin tester.
Time frame: Week 12
Facial skin wrinkles change from baseline
Obtain and assess wrinkles with Antera 3D tester.
Time frame: Week 12
Facial skin texture change from baseline
Obtain and assess texture with Antera 3D tester.
Time frame: Week 12
Facial skin pore change from baseline
Obtain and assess pore size with Antera 3D tester.
Time frame: Week 12
Facial skin depression/elevation change from baseline
Obtain and assess depression/elevation with Antera 3D tester.
Time frame: Week 12
Facial skin melanin values change from baseline
Obtain and assess melanin values with Antera 3D tester.
Time frame: Week 12
Facial skin hemoglobin values change from baseline
Obtain and assess hemoglobin values with Antera 3D tester.
Time frame: Week 12
Assess the safety of P29429-01 as a skin care product
Assess the incidence of adverse events.
Time frame: Week 1~12
Assess the safety of P29429-01 as a skin care product with skin health questionnaires
The skin health questionnaires is an ordinal scale used to assess the skin health, such as skin inflammation ,red, scaling, itchy, and achy.
Time frame: Week 1~12
Study compliance of the subjects
Assess with phone calls and clinic visits.
Time frame: Week-4~12
Assess P29429-01 satisfaction of the subjects with satisfaction questionnaires
The satisfaction questionnaires is a Likert scale used to assess satisfaction of the subjects, such as improvement of facial skin hydration, elasticity, wrinkles, texture and appearance.
Time frame: Week 1~12
The effect of P29429-01 in increasing hyaluronic acid, collagen and elastic fiber using skin tissue biopsy
For subjects agreeing to provide a skin tissue biopsy, the skin biopsy is obtained from a small area on the medial side of the forearm.
Time frame: At week -1 and Week 12