Clinical trial NCT04015063: Efficacy and Safety of Skin Care Product in Aging Facial Skin
Official title: A Single-Arm, Open-Label, Single Center Clinical Study to Evaluate the Efficacy and Safety of P29429-01 in Aging Facial Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Keywords: Dermatology
Skin Care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 35
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Facial skin hydration change from baseline
timeFrame: Week 12
measure: Facial skin elasticity change from baseline
timeFrame: Week 12
Secondary outcomes:
measure: Facial spots change from baseline
timeFrame: Week 12
measure: Facial pores change from baseline
timeFrame: Week 12
measure: Facial wrinkles change from baseline
timeFrame: Week 12
measure: Facial texture change from baseline
timeFrame: Week 12
measure: Facial porphyrin (from Propionibacterium acnes) change from baseline
timeFrame: Week 12
measure: Facial brown spots change from baseline
timeFrame: Week 12
measure: Facial red area change from baseline
timeFrame: Week 12
measure: Facial UV spots change from baseline
timeFrame: Week 12
measure: Sebumeter values change from baseline
timeFrame: Week 12
measure: Mexameter values change from baseline
timeFrame: Week 12
measure: Transepidermal water loss (TEWL) by tewameter change from baseline
timeFrame: Week 12
measure: Facial skin wrinkles change from baseline
timeFrame: Week 12
measure: Facial skin texture change from baseline
timeFrame: Week 12
measure: Facial skin pore change from baseline
timeFrame: Week 12
measure: Facial skin depression/elevation change from baseline
timeFrame: Week 12
measure: Facial skin melanin values change from baseline
timeFrame: Week 12
measure: Facial skin hemoglobin values change from baseline
timeFrame: Week 12
measure: Assess the safety of P29429-01 as a skin care product
timeFrame: Week 1~12
measure: Assess the safety of P29429-01 as a skin care product with skin health questionnaires
timeFrame: Week 1~12
measure: Study compliance of the subjects
timeFrame: Week-4~12
measure: Assess P29429-01 satisfaction of the subjects with satisfaction questionnaires
timeFrame: Week 1~12
measure: The effect of P29429-01 in increasing hyaluronic acid, collagen and elastic fiber using skin tissue biopsy
timeFrame: At week -1 and Week 12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hosptal
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Hua Liao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.