Status:
UNKNOWN
Efficacy and Safety of Skin Care Product in Aging Facial Skin
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Skin Aging
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
- Inclusion Criteria for Substudy:
- Has provided written informed consent for the main study;
- 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.
- Exclusion Criteria for Substudy:
- Currently using anticoagulants;
- Patients with severe coagulation disorder;
- Patients with keloid predisposition.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04015063
Start Date
March 4 2019
End Date
December 13 2019
Last Update
July 10 2019
Active Locations (1)
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1
National Taiwan University Hosptal
Taipei, Taiwan, 100