| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Skin Aging | Other: Anti-Aging Skin Care product | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin |
| Actual Study Start Date : | March 4, 2019 |
| Estimated Primary Completion Date : | July 5, 2019 |
| Estimated Study Completion Date : | December 13, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
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.
|
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.
Other Name: P29429-01
|
| Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for Substudy:
Exclusion Criteria for Substudy:
| Taiwan | |
| National Taiwan University Hosptal | |
| Taipei, Taiwan, 100 | |
| Principal Investigator: | Yi-Hua Liao, Ph.D | National Taiwan University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 4, 2019 | ||||
| First Posted Date ICMJE | July 10, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Actual Study Start Date ICMJE | March 4, 2019 | ||||
| Estimated Primary Completion Date | July 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Skin Care Product in Aging Facial Skin | ||||
| Official Title ICMJE | A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin | ||||
| Brief 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||
| Condition ICMJE | Skin Aging | ||||
| Intervention ICMJE | 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.
Other Name: P29429-01
|
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| Study Arms ICMJE | 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.
Intervention: Other: Anti-Aging Skin Care product
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Actual Enrollment ICMJE |
35 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 13, 2019 | ||||
| Estimated Primary Completion Date | July 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for Substudy:
Exclusion Criteria for Substudy:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04015063 | ||||
| Other Study ID Numbers ICMJE | 201810063RSD | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | National Taiwan University Hospital | ||||
| Verification Date | December 2018 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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