NCT04015063

Efficacy and Safety of Skin Care Product in Aging Facial Skin

A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Aging

Interventions

Type	Name	Description
OTHER	Anti-Aging Skin Care product	Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week.

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-07-05
• Completion: 2019-12-13
• First posted: 2019-07-10
• Last updated: 2019-07-10

Locations

1 site across 1 country: Taiwan