Skin AgingNCT04015063
Efficacy and Safety of Skin Care Product in Aging Facial Skin
A study testing Anti-Aging Skin Care product in people with Skin Aging, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Anti-Aging Skin Care product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2019to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females 40~65 years of age;
- Subjects are not found with facial skin tissue changes or inflammation as determined by the investigator ;
- Has skin aging of Glogau class II, i.e. presence of wrinkles during facial movement or resting, as determined by the investigator;
- The subject is able to understand and comply with the requirements, instructions and restrictions specified in the protocol; and
- Sign on the informed consent form.
- Has provided written informed consent for the main study;
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- 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;
- The subject is able to understand and comply with the requirements, instructions and restrictions specified in the substudy;
- Sign and date on the informed consent form of the substudy.
Who cannot join
- Received active facial treatment including laser, pulse light, CPT Thermage, HIFU lifting or subcutaneous filler injection in the last 6 months;
- Has history of chronic skin condition or autoimmune disorders such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea or keloid;
- Has history of allergy to the study skin care product (P29429-01) compositions, moisturizer or sunscreen;
- Pregnant or breastfeeding women;
- 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;
- Required treatment for any acute condition or infection within 14 days before the study;
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- Experienced a serious medical condition such as disease of the heart, lungs, brain and/or liver within 3 months before the study;
- Has been a routine smoker within 12 months before the study;
- Currently has malignant tumor;
- 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;
- Has participated in another clinical trial within 30 days before the study;
- Receiving medical management that may affect the ability to participate in this study;
- Inappropriate for participating in this study as deemed by the principal investigator.
- Currently using anticoagulants;
- Patients with severe coagulation disorder;
- Patients with keloid predisposition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin
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.
- Conditions
- Skin Aging
- Being tested
- Anti-Aging Skin Care product
- Keywords
- Dermatology, Skin Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Aging Skin Care productOther
Also called P29429-01
Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week.
| Study group | Role | What they receive |
|---|---|---|
| Primary Subjects | Other | 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. Receives: Other: Anti-Aging Skin Care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial skin hydration change from baseline
Corneum hydration of the skin will be determined using CK's Corneometry
Measured: Week 12
Facial skin elasticity change from baseline
Elasticity of the skin will be determined using CK's Cutometer.
Measured: Week 12
Secondary outcomes (22)
Facial spots change from baseline
Assess facial skin spots with VISIA advanced skin tester.
Measured: Week 12
Facial pores change from baseline
Assess pore size with VISIA advanced skin tester.
Measured: Week 12
Facial wrinkles change from baseline
Assess wrinkles with VISIA advanced skin tester.
Measured: Week 12
Facial texture change from baseline
Assess texture with VISIA advanced skin tester.
Measured: Week 12
Facial porphyrin (from Propionibacterium acnes) change from baseline
Assess porphyrin values with VISIA advanced skin tester.
Measured: Week 12
Facial brown spots change from baseline
Assess brown spots with VISIA advanced skin tester.
Measured: Week 12
Facial red area change from baseline
Assess red area with VISIA advanced skin tester.
Measured: Week 12
Facial UV spots change from baseline
Assess UV spots with VISIA advanced skin tester.
Measured: Week 12
Sebumeter values change from baseline
Measure sebum (oil) on the skin with CK skin tester.
Measured: Week 12
Mexameter values change from baseline
Measure melanin content on the skin with CK skin tester.
Measured: Week 12
Transepidermal water loss (TEWL) by tewameter change from baseline
Transepidermal water loss (TEWL) with CK skin tester.
Measured: Week 12
Facial skin wrinkles change from baseline
Obtain and assess wrinkles with Antera 3D tester.
Measured: Week 12
Facial skin texture change from baseline
Obtain and assess texture with Antera 3D tester.
Measured: Week 12
Facial skin pore change from baseline
Obtain and assess pore size with Antera 3D tester.
Measured: Week 12
Facial skin depression/elevation change from baseline
Obtain and assess depression/elevation with Antera 3D tester.
Measured: Week 12
Facial skin melanin values change from baseline
Obtain and assess melanin values with Antera 3D tester.
Measured: Week 12
Facial skin hemoglobin values change from baseline
Obtain and assess hemoglobin values with Antera 3D tester.
Measured: Week 12
Assess the safety of P29429-01 as a skin care product
Assess the incidence of adverse events.
Measured: 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.
Measured: Week 1~12
Study compliance of the subjects
Assess with phone calls and clinic visits.
Measured: 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.
Measured: 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.
Measured: At week -1 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start4 Mar 2019
- Primary completion5 Jul 2019 (estimated)
- Study completion13 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hua Liao, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015063
- Sponsor's protocol ID
- 201810063RSD
- Status last verified
- Dec 2018
- First submitted
- 4 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 5361423Uitto 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 2674224Melchini 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin
- ClinicalTrials.gov ID
- NCT04015063
- Acronym / sponsor ID
- 201810063RSD
- Conditions
- Skin Aging
- Keywords
- Dermatology, Skin Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 5 Jul 2019 (estimated)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Subjects | Other | Other: Anti-Aging Skin Care productWomen subjects 40-65 years of age that meet the specified inclusion/exclusion criteria taking P29429-01 as a skin care product per the protocol. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females 40~65 years of age;
- Subjects are not found with facial skin tissue changes or inflammation as determined by the investigator ;
- Has skin aging of Glogau class II, i.e. presence of wrinkles during facial movement or resting, as determined by the investigator;
- The subject is able to understand and comply with the requirements, instructions and restrictions specified in the protocol; and
- Sign on the informed consent form.
Key exclusion criteria (16 listed)
- Received active facial treatment including laser, pulse light, CPT Thermage, HIFU lifting or subcutaneous filler injection in the last 6 months;
- Has history of chronic skin condition or autoimmune disorders such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea or keloid;
- Has history of allergy to the study skin care product (P29429-01) compositions, moisturizer or sunscreen;
- Pregnant or breastfeeding women;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Aging Skin Care productAlso: P29429-01Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week. | Other | Primary Subjects |
Primary outcome
Facial skin hydration change from baseline
Time frame: Week 12
Corneum hydration of the skin will be determined using CK's Corneometry
Facial skin elasticity change from baseline
Time frame: Week 12
Elasticity of the skin will be determined using CK's Cutometer.
22 secondary outcomes
Facial spots change from baseline
Time frame: Week 12
Facial pores change from baseline
Time frame: Week 12
Facial wrinkles change from baseline
Time frame: Week 12
Facial texture change from baseline
Time frame: Week 12
Facial porphyrin (from Propionibacterium acnes) change from baseline
Time frame: Week 12
Facial brown spots change from baseline
Time frame: Week 12
Facial red area change from baseline
Time frame: Week 12
Facial UV spots change from baseline
Time frame: Week 12
Sebumeter values change from baseline
Time frame: Week 12
Mexameter values change from baseline
Time frame: Week 12
Transepidermal water loss (TEWL) by tewameter change from baseline
Time frame: Week 12
Facial skin wrinkles change from baseline
Time frame: Week 12
Facial skin texture change from baseline
Time frame: Week 12
Facial skin pore change from baseline
Time frame: Week 12
Facial skin depression/elevation change from baseline
Time frame: Week 12
Facial skin melanin values change from baseline
Time frame: Week 12
Facial skin hemoglobin values change from baseline
Time frame: Week 12
Assess the safety of P29429-01 as a skin care product
Time frame: Week 1~12
Assess the safety of P29429-01 as a skin care product with skin health questionnaires
Time frame: Week 1~12
Study compliance of the subjects
Time frame: Week-4~12
Assess P29429-01 satisfaction of the subjects with satisfaction questionnaires
Time frame: Week 1~12
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 5361423Black 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.
- Background: PubMed 2674224Uitto 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.
- Background: PubMed 21720915Melchini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hua Liao, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Aging Skin Care product in people with Skin Aging, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial skin hydration change from baseline (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015063, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.