- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379216
Efficacy Evaluation Study of Vitamin C and Glutathione Liquid Sachet
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, placebo-controlled, double-blinded, parallel human trial designed to evaluate the skin beauty and anti-oxidant effect of liquid vitamin C and glutathione supplements.
Healthy adult participants aged 18-65 years will be enrolled. Participants will be informed to consume test samples daily for 12 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after 4, 8 weeks, and 12 weeks of consumption. Fasting blood samples will be collected at baseline and after 12 weeks of consumption.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ping Lin
- Phone Number: +886-02-87977811
- Email: candice.lin@tci-bio.com
Study Contact Backup
- Name: Chia-Hua Liang, Ph.D.
- Phone Number: 2441 +886-06-2664911
- Email: tinna_ling@mail.cnu.edu.tw
Study Locations
-
-
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Pingtung City, Taiwan, 928
- Recruiting
- Chia Nan University of Pharmacy & Science
-
Principal Investigator:
- Chia-Hua Liang, Ph.D.
-
Contact:
- Chia-Hua Liang, Ph.D.
- Phone Number: 2441 +886-06-2664911
- Email: tinna_ling@mail.cnu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy male or female adults, aged 18-65 years old;
- Commitment not to use products having activity comparable with that of the product to be tested during the study period;
- Free of any dermatological or systemic disorder that would interfere with results.
Exclusion Criteria:
- Subject with obvious skin surface damage;
- Subject who had oral or topical medication which may affect skin condition within 1 month;
- Individuals with known allergies to cosmetics, medications, or foods (especially those allergic to legumes/soy);
- Pregnant or breastfeeding individuals;
- Received facial laser therapy, chemical peeling in the past 2 months.
- Individuals unwilling to allow publication or public disclosure of photographs taken as part of the study results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo sachet
|
consume 1 sachet of the test samples daily for 12 consecutive weeks
|
|
Experimental: Vitamin C and Glutathione Liquid Sachet
|
consume 1 sachet of the test samples daily for 12 consecutive weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of skin tone
Time Frame: Change from Baseline skin tone at 12 weeks
|
Chroma Meter MM500 was utilized to measure face skin tone.
Units: Individual Typology Angle (ITA°)
|
Change from Baseline skin tone at 12 weeks
|
|
The change of visible spots
Time Frame: Change from Baseline visible spots at 12 weeks
|
VISIA Complexion Analysis was utilized to measure visible spots on face.
Units: the amount of detectable visible spots
|
Change from Baseline visible spots at 12 weeks
|
|
The change of UV spots
Time Frame: Change from Baseline UV spots at 12 weeks
|
VISIA Complexion Analysis was utilized to measure UV spots on face.
Units: the amount of detectable UV spots
|
Change from Baseline UV spots at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of skin collagen density
Time Frame: Change from Baseline skin collagen density at 12 weeks
|
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density.
Units: arbitrary units
|
Change from Baseline skin collagen density at 12 weeks
|
|
The change of skin melanin index
Time Frame: Change from Baseline skin melanin index at 12 weeks
|
Mexameter® MX18 (CK, Germany) was utilized to measure face skin melanin level.
Units: arbitrary units
|
Change from Baseline skin melanin index at 12 weeks
|
|
The change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 12 weeks
|
Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity.
Units: arbitrary units
|
Change from Baseline skin elasticity at 12 weeks
|
|
The change of brown spots
Time Frame: Change from Baseline brown spots at 12 weeks
|
VISIA Complexion Analysis was utilized to measure brown spots on face.
Units: the amount of detectable brown spots
|
Change from Baseline brown spots at 12 weeks
|
|
The change of wrinkles around the eyes
Time Frame: Change from Baseline wrinkles around the eyes at 12 weeks
|
VISIA Complexion Analysis was utilized to measure wrinkles around the eyes.
Units: the amount of detectable wrinkles
|
Change from Baseline wrinkles around the eyes at 12 weeks
|
|
The change of skin texture
Time Frame: Change from Baseline skin texture at 12 weeks
|
VISIA Complexion Analysis was utilized to measure skin texture.
Units: arbitrary units
|
Change from Baseline skin texture at 12 weeks
|
|
The change of total antioxidation capacity (TAC)
Time Frame: Change from Baseline TAC at 12 weeks
|
A fasting blood sample will be collected for TAC testing.
|
Change from Baseline TAC at 12 weeks
|
|
The change of Superoxide Dismutase (SOD)
Time Frame: Change from Baseline SOD at 12 weeks
|
A fasting blood sample will be collected for SOD testing.
|
Change from Baseline SOD at 12 weeks
|
|
The change of Glutathione S-transferase-Red Blood Cells (GST-RBC)
Time Frame: Change from Baseline GST-RBC at 12 weeks
|
A fasting blood sample will be collected for GST-RBC testing.
|
Change from Baseline GST-RBC at 12 weeks
|
|
The change of Malondialdehyde (MDA)
Time Frame: Change from Baseline MDA at 12 weeks
|
A fasting blood sample will be collected for MDA testing.
|
Change from Baseline MDA at 12 weeks
|
|
The change of skin hydration
Time Frame: Change from Baseline skin hydration at 12 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 12 weeks
|
|
The change of skin redness
Time Frame: Change from Baseline skin redness at 12 weeks
|
Chroma Meter MM500 was utilized to measure face skin redness.
Units: a* value
|
Change from Baseline skin redness at 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of self-assessment fatigue level
Time Frame: Change from Baseline fatigue level at 12 weeks
|
Fatigue Symptom Inventory (FSI) was collected and evaluate fatigue level.
Most items are rated on an 11-point Likert scale ranging from 0 to 10.
The scores are generally averaged to create subscales for intensity and interference.
|
Change from Baseline fatigue level at 12 weeks
|
|
The change of blood liver function biomarkers (AST, ALT)
Time Frame: Change from Baseline liver function biomarkers at 12 weeks
|
A fasting blood sample will be collected for liver function biomarkers testing.
|
Change from Baseline liver function biomarkers at 12 weeks
|
|
The change of blood renal function biomarkers (creatinine, BUN)
Time Frame: Change from Baseline renal function biomarkers at 12 weeks
|
A fasting blood sample will be collected for renal function biomarkers testing.
|
Change from Baseline renal function biomarkers at 12 weeks
|
|
The change of self-assessment skin condition
Time Frame: Change from Baseline skin condition at 12 weeks
|
Skin condition was evaluated using a 5-point Likert scale (0-4) to assess the severity of skin-related symptoms.
The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Change from Baseline skin condition at 12 weeks
|
|
The change of self-assessment Low Immunity level
Time Frame: Change from Baseline Low Immunity level at 12 weeks
|
Low Immunity level was evaluated using a 5-point Likert scale (0-4) to assess the severity of Low Immunity-related symptoms.
The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Change from Baseline Low Immunity level at 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chia-Hua Liang, Ph.D., Chia Nan University of Pharmacy & Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-103-A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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