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OpenTrials
Completed

NCT Number: NCT05311020

Efficacy Evaluation of Pitaya Ovule Extract on Skin

To assess the efficacy of Pitaya Ovule Extract on skin

Completed

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Key information

Conditions

Skin Condition Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 bottle per day

Pitaya Ovule Extract Drink

Dietary Supplement

consume 1 bottle per day

Primary outcomes

  1. The change of L* (lightness) values

    Time frame: Change from Baseline L* value at 8 weeks

    Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units

  2. The change of skin elasticity

    Time frame: Change from Baseline skin elasticity at 8 weeks

    Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units

  3. The change of skin collagen density

    Time frame: Change from Baseline skin collagen density at 8 weeks

    DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units

  4. The change of skin wrinkles

    Time frame: Change from Baseline skin wrinkles at 8 weeks

    IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units

  5. The change of skin texture

    Time frame: Change from Baseline skin texture at 8 weeks

    IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units

  6. The change of skin pores

    Time frame: Change from Baseline skin pores at 8 weeks

    IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units

  7. The change of skin tone

    Time frame: Change from Baseline skin tone at 8 weeks

    IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units

  8. The change of Advanced glycation end products of blood

    Time frame: Change from Baseline AGEs at 8 weeks

    Venous blood was sampled to measure AGEs

  9. The change of RAGE (receptor for advanced glycation end products) of blood

    Time frame: Change from Baseline RAGE at 8 weeks

    Venous blood was sampled to measure RAGE

  10. The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood

    Time frame: Change from Baseline MMPs at 8 weeks

    Venous blood was sampled to measure MMPs

Secondary outcomes

  1. The change of liver function biomarkers (AST, ALT) of blood

    Time frame: Change from Baseline liver function biomarkers at 8 weeks

    Venous blood was sampled to measure liver function biomarkers

  2. The change of renal function biomarkers (creatinine, BUN) of blood

    Time frame: Change from Baseline renal function biomarkers at 8 weeks

    Venous blood was sampled to measure renal function biomarkers

  3. The change of fasting blood glucose level

    Time frame: Change from Baseline fasting blood glucose level at 8 weeks

    Venous blood was sampled to measure fasting blood glucose level

  4. Change from Baseline insulin level at 8 weeks

    Time frame: Change from Baseline insulin level at 8 weeks

    Venous blood was sampled to measure insulin level

  5. The change of blood lipid profile

    Time frame: Change from Baseline blood lipid profile at 8 weeks

    Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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