Efficacy Evaluation of Blood Peach Extract and Rose Apple Extract on Skin
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ping Lin
- Phone Number: +886-02-879778111
- Email: candice.lin@tci-bio.com
Study Contact Backup
- Name: Hsiu-Mei Chiang
- Phone Number: 5302 +886-04-22053366
- Email: hmchiang@mail.cmu.edu.tw
Study Locations
-
-
-
Taichung City, Taiwan, 406040
- China Medical University of Department of Cosmeceutics
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adult females aged 20 to 65;
- Preferably those with pale complexion or signs of iron deficiency anemia.
Exclusion Criteria:
- Currently undergoing or having undergone any medical beauty treatments within the past month (including skincare, laser treatments, chemical peel, injections, or cosmetic surgery);
- Outdoor workers (exposed to sunlight for more than 5 hours daily);
- Pregnant, breastfeeding, or planning to become pregnant during the trial (self-reported);
- Individuals with heart, liver, kidney, endocrine, or other significant organic diseases (self-reported);
- Individuals who have undergone major surgery (according to medical history);
- Long-term medication users;
- Individuals with mental health disorders;
- Those who are already regularly taking iron supplements;
- Faculty or staff members who are currently enrolled in the principal investigator's courses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Take one bottle of the product every morning on an empty stomach
|
|
Experimental: Blood Peach Extract
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Take one bottle of the product every morning on an empty stomach
|
|
Experimental: Rose Apple Extract
|
Take one bottle of the product every morning on an empty stomach
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the volume of skin wrinkles
Time Frame: Volume change from Baseline skin wrinkles at 8 weeks
|
IRV full-face skin analyzer was utilized to measure skin wrinkles.
Units: arbitrary units
|
Volume change from Baseline skin wrinkles at 8 weeks
|
|
the roughness of skin texture
Time Frame: Rating skin roughness from Baseline skin texture at 8 weeks
|
IRV full-face skin analyzer was utilized to measure skin texture.
Units: arbitrary units
|
Rating skin roughness from Baseline skin texture at 8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 8 weeks
|
Cutometer® was utilized to measure skin elasticity.
Units: arbitrary units
|
Change from Baseline skin elasticity at 8 weeks
|
|
the change of skin collagen density
Time Frame: Change from Baseline skin collagen density at 8 weeks
|
Dermalab® Combo was utilized to measure skin collagen density.
Units: arbitrary units
|
Change from Baseline skin collagen density at 8 weeks
|
|
the change of skin pores
Time Frame: Change from Baseline skin pores at 8 weeks
|
IRV full-face skin analyzer was utilized to measure skin pores.
Units: arbitrary units
|
Change from Baseline skin pores at 8 weeks
|
|
the change of skin tone
Time Frame: Change from Baseline skin tone at 8 weeks
|
IRV full-face skin analyzer was utilized to measure skin tone.
Units: arbitrary units
|
Change from Baseline skin tone at 8 weeks
|
|
the change of skin hydration
Time Frame: Change from Baseline skin hydration at 8 weeks
|
Corneometer® was utilized to measure skin hydration.
Units: arbitrary units
|
Change from Baseline skin hydration at 8 weeks
|
|
the change of skin melanin/erythema index
Time Frame: Change from Baseline skin melanin/erythema index at 8 weeks
|
Mexameter® was utilized to measure skin melanin/erythema index.
Units: arbitrary units
|
Change from Baseline skin melanin/erythema index at 8 weeks
|
|
the change of skin redness
Time Frame: Change from Baseline skin redness at 8 weeks
|
Colorimeter was utilized to measure skin redness.
Units: arbitrary units
|
Change from Baseline skin redness at 8 weeks
|
|
the change of lip redness
Time Frame: Change from Baseline lip redness at 8 weeks
|
Antera 3D® was utilized to measure lip redness.
Units: arbitrary units
|
Change from Baseline lip redness at 8 weeks
|
|
the change of Red Blood Cells (RBC) Count of blood
Time Frame: Change from Baseline RBC count at 8 weeks
|
venous blood was sampled to measure RBC count
|
Change from Baseline RBC count at 8 weeks
|
|
the change of hemoglobin level of blood
Time Frame: Change from Baseline hemoglobin level at 8 weeks
|
venous blood was sampled to measure hemoglobin level
|
Change from Baseline hemoglobin level at 8 weeks
|
|
the change of mean corpuscular volume (M.C.V) level of blood
Time Frame: Change from Baseline M.C.V level at 8 weeks
|
venous blood was sampled to measure M.C.V level
|
Change from Baseline M.C.V level at 8 weeks
|
|
the change of mean corpuscular hemoglobin concentration (M.C.H.C) level of blood
Time Frame: Change from Baseline M.C.H.C level at 8 weeks
|
venous blood was sampled to measure M.C.H.C level
|
Change from Baseline M.C.H.C level at 8 weeks
|
|
the change of ferrous level of blood
Time Frame: Change from Baseline ferrous level at 8 weeks
|
venous blood was sampled to measure ferrous level
|
Change from Baseline ferrous level at 8 weeks
|
|
the change of ferritin level of blood
Time Frame: Change from Baseline ferritin level at 8 weeks
|
venous blood was sampled to measure ferritin level
|
Change from Baseline ferritin level at 8 weeks
|
|
the change of Total Iron Binding Capacity (TIBC) level of blood
Time Frame: Change from Baseline TIBC level at 8 weeks
|
venous blood was sampled to measure TIBC level
|
Change from Baseline TIBC level at 8 weeks
|
|
the change of unsaturated iron-binding capacity (UIBC) level of blood
Time Frame: Change from Baseline UIBC level at 8 weeks
|
venous blood was sampled to measure UIBC level
|
Change from Baseline UIBC level at 8 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
change from Baseline liver function biomarkers at 8 weeks
|
|
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
|
change from Baseline renal function biomarkers at 8 weeks
|
|
the change of fasting glucose level of blood
Time Frame: change from Baseline fasting glucose level at 8 weeks
|
venous blood was sampled to measure fasting glucose level
|
change from Baseline fasting glucose level at 8 weeks
|
|
the change of Advanced glycation end products (AGEs) level of blood
Time Frame: change from Baseline AGEs level at 8 weeks
|
venous blood was sampled to measure AGEs level
|
change from Baseline AGEs level at 8 weeks
|
|
The change of self-assessment skin and metabolic circulation condition
Time Frame: Change from Baseline skin and metabolic circulation condition at 8 weeks
|
A self-assessment questionnaire was collected to evaluate skin and metabolic circulation condition.
As for the evalutation of skin condition, the higher score the better; As for evaluation of metabolic circulation condition, the higher score the worse.
|
Change from Baseline skin and metabolic circulation condition at 8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Hsiu-Mei Chiang, China Medical University of Department of Cosmeceutics
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- CMUH114-REC3-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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