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Status unknownNCT04015063Updated Jul 10, 2019

Efficacy and Safety of Skin Care Product in Aging Facial Skin

An interventional study of Anti-Aging Skin Care product in Skin Aging, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2019, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Aging

Keywords

  • Dermatology
  • Skin Care
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    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

Interventions

  • OtherAnti-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.

    Also known as: P29429-01

06

What researchers measure

Primary outcomes

  1. Facial skin hydration change from baseline

    Corneum hydration of the skin will be determined using CK's Corneometry

    Time frame: Week 12

  2. Facial skin elasticity change from baseline

    Elasticity of the skin will be determined using CK's Cutometer.

    Time frame: Week 12

Secondary outcomes

  1. Facial spots change from baseline

    Assess facial skin spots with VISIA advanced skin tester.

    Time frame: Week 12

  2. Facial pores change from baseline

    Assess pore size with VISIA advanced skin tester.

    Time frame: Week 12

  3. Facial wrinkles change from baseline

    Assess wrinkles with VISIA advanced skin tester.

    Time frame: Week 12

  4. Facial texture change from baseline

    Assess texture with VISIA advanced skin tester.

    Time frame: Week 12

  5. Facial porphyrin (from Propionibacterium acnes) change from baseline

    Assess porphyrin values with VISIA advanced skin tester.

    Time frame: Week 12

  6. Facial brown spots change from baseline

    Assess brown spots with VISIA advanced skin tester.

    Time frame: Week 12

  7. Facial red area change from baseline

    Assess red area with VISIA advanced skin tester.

    Time frame: Week 12

  8. Facial UV spots change from baseline

    Assess UV spots with VISIA advanced skin tester.

    Time frame: Week 12

  9. Sebumeter values change from baseline

    Measure sebum (oil) on the skin with CK skin tester.

    Time frame: Week 12

  10. Mexameter values change from baseline

    Measure melanin content on the skin with CK skin tester.

    Time frame: Week 12

  11. Transepidermal water loss (TEWL) by tewameter change from baseline

    Transepidermal water loss (TEWL) with CK skin tester.

    Time frame: Week 12

  12. Facial skin wrinkles change from baseline

    Obtain and assess wrinkles with Antera 3D tester.

    Time frame: Week 12

  13. Facial skin texture change from baseline

    Obtain and assess texture with Antera 3D tester.

    Time frame: Week 12

  14. Facial skin pore change from baseline

    Obtain and assess pore size with Antera 3D tester.

    Time frame: Week 12

  15. Facial skin depression/elevation change from baseline

    Obtain and assess depression/elevation with Antera 3D tester.

    Time frame: Week 12

  16. Facial skin melanin values change from baseline

    Obtain and assess melanin values with Antera 3D tester.

    Time frame: Week 12

  17. Facial skin hemoglobin values change from baseline

    Obtain and assess hemoglobin values with Antera 3D tester.

    Time frame: Week 12

  18. Assess the safety of P29429-01 as a skin care product

    Assess the incidence of adverse events.

    Time frame: Week 1~12

  19. 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

  20. Study compliance of the subjects

    Assess with phone calls and clinic visits.

    Time frame: Week-4~12

  21. 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

  22. 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

07

Study locations

1 site
  • National Taiwan University Hosptal
    Taipei, 100, Taiwan
08

References and documents

Publications

  • Black MM. A modified radiographic method for measuring skin thickness. Br J Dermatol. 1969 Sep;81(9):661-6. doi: 10.1111/j.1365-2133.1969.tb16204.x. No abstract available. PubMed 5361423 ↗
  • Uitto J, Fazio MJ, Olsen DR. Molecular mechanisms of cutaneous aging. Age-associated connective tissue alterations in the dermis. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):614-22. PubMed 2674224 ↗
  • Melchini A, Catania S, Stancanelli R, Tommasini S, Costa C. Interaction of a functionalized complex of the flavonoid hesperetin with the AhR pathway and CYP1A1 expression: involvement in its protective effects against benzo[a]pyrene-induced oxidative stress in human skin. Cell Biol Toxicol. 2011 Oct;27(5):371-9. doi: 10.1007/s10565-011-9194-6. Epub 2011 Jul 1. PubMed 21720915 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04015063
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jul 10, 2019
Start date
Mar 4, 2019
Primary completion
Jul 5, 2019 (estimated)
Completion
Dec 13, 2019 (estimated)
Last update
Jul 10, 2019

Study contacts

Yi-Hua Liao, Ph.D
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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