Back to resultsEfficacy Evaluation of Pitaya Ovule Extract on Skin
Primary Purpose
Skin Condition
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Pitaya Ovule Extract Drink
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
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
Sites / Locations
- China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
Pitaya Ovule Extract Drink
Arm Description
Outcomes
Primary Outcome Measures
The change of L* (lightness) values
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
The change of skin elasticity
Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units
The change of skin collagen density
DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units
The change of skin wrinkles
IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units
The change of skin tone
IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units
The change of Advanced glycation end products of blood
Venous blood was sampled to measure AGEs
The change of RAGE (receptor for advanced glycation end products) of blood
Venous blood was sampled to measure RAGE
The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood
Venous blood was sampled to measure MMPs
Secondary Outcome Measures
The change of liver function biomarkers (AST, ALT) of blood
Venous blood was sampled to measure liver function biomarkers
The change of renal function biomarkers (creatinine, BUN) of blood
Venous blood was sampled to measure renal function biomarkers
The change of fasting blood glucose level
Venous blood was sampled to measure fasting blood glucose level
Change from Baseline insulin level at 8 weeks
Venous blood was sampled to measure insulin level
The change of blood lipid profile
Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05311020
Brief Title
Efficacy Evaluation of Pitaya Ovule Extract on Skin
Official Title
Efficacy Evaluation of Pitaya Ovule Extract on Skin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
January 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the efficacy of Pitaya Ovule Extract on skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Pitaya Ovule Extract Drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 1 bottle per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Pitaya Ovule Extract Drink
Intervention Description
consume 1 bottle per day
Primary Outcome Measure Information:
Title
The change of L* (lightness) values
Description
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
Time Frame
Change from Baseline L* value at 8 weeks
Title
The change of skin elasticity
Description
Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Change from Baseline skin elasticity at 8 weeks
Title
The change of skin collagen density
Description
DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units
Time Frame
Change from Baseline skin collagen density at 8 weeks
Title
The change of skin wrinkles
Description
IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 8 weeks
Title
The change of skin texture
Description
IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 8 weeks
Title
The change of skin pores
Description
IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin pores at 8 weeks
Title
The change of skin tone
Description
IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units
Time Frame
Change from Baseline skin tone at 8 weeks
Title
The change of Advanced glycation end products of blood
Description
Venous blood was sampled to measure AGEs
Time Frame
Change from Baseline AGEs at 8 weeks
Title
The change of RAGE (receptor for advanced glycation end products) of blood
Description
Venous blood was sampled to measure RAGE
Time Frame
Change from Baseline RAGE at 8 weeks
Title
The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood
Description
Venous blood was sampled to measure MMPs
Time Frame
Change from Baseline MMPs at 8 weeks
Secondary Outcome Measure Information:
Title
The change of liver function biomarkers (AST, ALT) of blood
Description
Venous blood was sampled to measure liver function biomarkers
Time Frame
Change from Baseline liver function biomarkers at 8 weeks
Title
The change of renal function biomarkers (creatinine, BUN) of blood
Description
Venous blood was sampled to measure renal function biomarkers
Time Frame
Change from Baseline renal function biomarkers at 8 weeks
Title
The change of fasting blood glucose level
Description
Venous blood was sampled to measure fasting blood glucose level
Time Frame
Change from Baseline fasting blood glucose level at 8 weeks
Title
Change from Baseline insulin level at 8 weeks
Description
Venous blood was sampled to measure insulin level
Time Frame
Change from Baseline insulin level at 8 weeks
Title
The change of blood lipid profile
Description
Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
Time Frame
Change from Baseline blood lipid profile at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Mei Chiang, Prof.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Po-Yuan Wu, Dr.
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
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Efficacy Evaluation of Pitaya Ovule Extract on Skin
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