Efficacy Evaluation of Pitaya Ovule Extract on Skin

Skin Condition Clinical Trial

Official title:

Efficacy Evaluation of Pitaya Ovule Extract on Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311020
• Other study ID #: CMUH111-REC3-028-2
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: January 16, 2023

Study information

• Verified date: September 2022
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of Pitaya Ovule Extract on skin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 16, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle per day
• Pitaya Ovule Extract Drink
consume 1 bottle per day

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The change of Advanced glycation end products of blood	Venous blood was sampled to measure AGEs	Change from Baseline AGEs at 8 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change from Baseline insulin level at 8 weeks	Venous blood was sampled to measure insulin level	Change from Baseline insulin level at 8 weeks
Secondary	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