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Efficacy and Safety of Skin Care Product in Aging Facial Skin

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ClinicalTrials.gov Identifier: NCT04015063
Recruitment Status : Unknown
Verified December 2018 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Skin Aging Other: Anti-Aging Skin Care product Not Applicable

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 : 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

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




Primary Outcome Measures :
  1. Facial skin hydration change from baseline [ Time Frame: Week 12 ]
    Corneum hydration of the skin will be determined using CK's Corneometry

  2. Facial skin elasticity change from baseline [ Time Frame: Week 12 ]
    Elasticity of the skin will be determined using CK's Cutometer.


Secondary Outcome Measures :
  1. Facial spots change from baseline [ Time Frame: Week 12 ]
    Assess facial skin spots with VISIA advanced skin tester.

  2. Facial pores change from baseline [ Time Frame: Week 12 ]
    Assess pore size with VISIA advanced skin tester.

  3. Facial wrinkles change from baseline [ Time Frame: Week 12 ]
    Assess wrinkles with VISIA advanced skin tester.

  4. Facial texture change from baseline [ Time Frame: Week 12 ]
    Assess texture with VISIA advanced skin tester.

  5. Facial porphyrin (from Propionibacterium acnes) change from baseline [ Time Frame: Week 12 ]
    Assess porphyrin values with VISIA advanced skin tester.

  6. Facial brown spots change from baseline [ Time Frame: Week 12 ]
    Assess brown spots with VISIA advanced skin tester.

  7. Facial red area change from baseline [ Time Frame: Week 12 ]
    Assess red area with VISIA advanced skin tester.

  8. Facial UV spots change from baseline [ Time Frame: Week 12 ]
    Assess UV spots with VISIA advanced skin tester.

  9. Sebumeter values change from baseline [ Time Frame: Week 12 ]
    Measure sebum (oil) on the skin with CK skin tester.

  10. Mexameter values change from baseline [ Time Frame: Week 12 ]
    Measure melanin content on the skin with CK skin tester.

  11. Transepidermal water loss (TEWL) by tewameter change from baseline [ Time Frame: Week 12 ]
    Transepidermal water loss (TEWL) with CK skin tester.

  12. Facial skin wrinkles change from baseline [ Time Frame: Week 12 ]
    Obtain and assess wrinkles with Antera 3D tester.

  13. Facial skin texture change from baseline [ Time Frame: Week 12 ]
    Obtain and assess texture with Antera 3D tester.

  14. Facial skin pore change from baseline [ Time Frame: Week 12 ]
    Obtain and assess pore size with Antera 3D tester.

  15. Facial skin depression/elevation change from baseline [ Time Frame: Week 12 ]
    Obtain and assess depression/elevation with Antera 3D tester.

  16. Facial skin melanin values change from baseline [ Time Frame: Week 12 ]
    Obtain and assess melanin values with Antera 3D tester.

  17. Facial skin hemoglobin values change from baseline [ Time Frame: Week 12 ]
    Obtain and assess hemoglobin values with Antera 3D tester.

  18. Assess the safety of P29429-01 as a skin care product [ Time Frame: Week 1~12 ]
    Assess the incidence of adverse events.

  19. Assess the safety of P29429-01 as a skin care product with skin health questionnaires [ Time Frame: Week 1~12 ]
    The skin health questionnaires is an ordinal scale used to assess the skin health, such as skin inflammation ,red, scaling, itchy, and achy.

  20. Study compliance of the subjects [ Time Frame: Week-4~12 ]
    Assess with phone calls and clinic visits.

  21. Assess P29429-01 satisfaction of the subjects with satisfaction questionnaires [ Time Frame: Week 1~12 ]
    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.

  22. The effect of P29429-01 in increasing hyaluronic acid, collagen and elastic fiber using skin tissue biopsy [ Time Frame: At week -1 and Week 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

Inclusion Criteria:

  1. Females 40~65 years of age;
  2. Subjects are not found with facial skin tissue changes or inflammation as determined by the investigator ;
  3. Has skin aging of Glogau class II, i.e. presence of wrinkles during facial movement or resting, as determined by the investigator;
  4. The subject is able to understand and comply with the requirements, instructions and restrictions specified in the protocol; and
  5. Sign on the informed consent form.

Exclusion Criteria:

  1. Received active facial treatment including laser, pulse light, CPT Thermage, HIFU lifting or subcutaneous filler injection in the last 6 months;
  2. Has history of chronic skin condition or autoimmune disorders such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea or keloid;
  3. Has history of allergy to the study skin care product (P29429-01) compositions, moisturizer or sunscreen;
  4. Pregnant or breastfeeding women;
  5. 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;
  6. Required treatment for any acute condition or infection within 14 days before the study;
  7. Experienced a serious medical condition such as disease of the heart, lungs, brain and/or liver within 3 months before the study;
  8. Has been a routine smoker within 12 months before the study;
  9. Currently has malignant tumor;
  10. 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;
  11. Has participated in another clinical trial within 30 days before the study;
  12. Receiving medical management that may affect the ability to participate in this study;
  13. Inappropriate for participating in this study as deemed by the principal investigator.

Inclusion Criteria for Substudy:

  1. Has provided written informed consent for the main study;
  2. 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;
  3. The subject is able to understand and comply with the requirements, instructions and restrictions specified in the substudy;
  4. Sign and date on the informed consent form of the substudy.

Exclusion Criteria for Substudy:

  1. Currently using anticoagulants;
  2. Patients with severe coagulation disorder;
  3. Patients with keloid predisposition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015063


Locations
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Taiwan
National Taiwan University Hosptal
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yi-Hua Liao, Ph.D National Taiwan University Hospital
Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04015063    
Other Study ID Numbers: 201810063RSD
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Dermatology
Skin Care