Efficacy Evaluation of Pitaya Ovule Extract on Skin

To assess the efficacy of Pitaya Ovule Extract on skin

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Pitaya Ovule Extract Drink

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo drink	Dietary supplement: Placebo drink; consume 1 bottle per day
EXPERIMENTAL: Pitaya Ovule Extract Drink	Dietary supplement: Pitaya Ovule Extract Drink; consume 1 bottle per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of L* (lightness) values	Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units	Change from Baseline L* value at 8 weeks
The change of skin elasticity	Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
The change of skin collagen density	DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units	Change from Baseline skin collagen density at 8 weeks
The change of skin wrinkles	IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 8 weeks
The change of skin texture	IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 8 weeks
The change of skin pores	IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin pores at 8 weeks
The change of skin tone	IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units	Change from Baseline skin tone at 8 weeks
The change of Advanced glycation end products of blood	Venous blood was sampled to measure AGEs	Change from Baseline AGEs at 8 weeks
The change of RAGE (receptor for advanced glycation end products) of blood	Venous blood was sampled to measure RAGE	Change from Baseline RAGE at 8 weeks
The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood	Venous blood was sampled to measure MMPs	Change from Baseline MMPs at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of liver function biomarkers (AST, ALT) of blood	Venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood	Venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
The change of fasting blood glucose level	Venous blood was sampled to measure fasting blood glucose level	Change from Baseline fasting blood glucose level at 8 weeks
Change from Baseline insulin level at 8 weeks	Venous blood was sampled to measure insulin level	Change from Baseline insulin level at 8 weeks
The change of blood lipid profile	Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)	Change from Baseline blood lipid profile at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2022
• Primary Completion (ACTUAL): December 23, 2022
• Study Completion (ACTUAL): January 16, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CMUH111-REC3-028-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No