Clinical trial NCT05311020: Efficacy Evaluation of Pitaya Ovule Extract on Skin
Official title: Efficacy Evaluation of Pitaya Ovule Extract on Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the efficacy of Pitaya Ovule Extract on skin


Eligibility criteria: Inclusion Criteria:

* 20 to 65-year-old males or females

Exclusion Criteria:

* Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
* Outdoor workers (exposed to the sun more than 5 hours a day)
* People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
* People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
* People who have undergone major surgery (according to medical history)
* People who take drugs for a long time
* People with mental illness
* Students who are currently taking courses taught by the principal investigator of this trial

Primary outcomes:
measure: The change of L* (lightness) values
timeFrame: Change from Baseline L* value at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 8 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 8 weeks
measure: The change of skin tone
timeFrame: Change from Baseline skin tone at 8 weeks
measure: The change of Advanced glycation end products of blood
timeFrame: Change from Baseline AGEs at 8 weeks
measure: The change of RAGE (receptor for advanced glycation end products) of blood
timeFrame: Change from Baseline RAGE at 8 weeks
measure: The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood
timeFrame: Change from Baseline MMPs at 8 weeks
Secondary outcomes:
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: Change from Baseline liver function biomarkers at 8 weeks
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Change from Baseline renal function biomarkers at 8 weeks
measure: The change of fasting blood glucose level
timeFrame: Change from Baseline fasting blood glucose level at 8 weeks
measure: Change from Baseline insulin level at 8 weeks
timeFrame: Change from Baseline insulin level at 8 weeks
measure: The change of blood lipid profile
timeFrame: Change from Baseline blood lipid profile at 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Hsiu-Mei Chiang, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Po-Yuan Wu, Dr.
role: STUDY_DIRECTOR
References: