Efficacy Evaluation Study of Vitamin C and Glutathione Liquid Sachet

ConditionsSkin Condition Anti-Oxidative Stress

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorTCI Co., Ltd.

About this trial

The objective of this study is to evaluate the effect of liquid vitamin C and glutathione supplements on human skin condition improvement and anti-oxidation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Placebo sachet
Dietary supplement
consume 1 sachet of the test samples daily for 12 consecutive weeks
Vitamin C and Glutathione Liquid Sachet
Dietary supplement
consume 1 sachet of the test samples daily for 12 consecutive weeks

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Placebo sachetPlacebo comparator 1 intervention

Group B: Vitamin C and Glutathione Liquid SachetExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The change of skin tone

Chroma Meter MM500 was utilized to measure face skin tone. Units: Individual Typology Angle (ITA°)

Time frame

Change from Baseline skin tone at 12 weeks

The change of visible spots

VISIA Complexion Analysis was utilized to measure visible spots on face. Units: the amount of detectable visible spots

Time frame

Change from Baseline visible spots at 12 weeks

The change of UV spots

VISIA Complexion Analysis was utilized to measure UV spots on face. Units: the amount of detectable UV spots

Time frame

Change from Baseline UV spots at 12 weeks

Secondary outcomes

The change of skin hydration

Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120.

Time frame

Change from Baseline skin hydration at 12 weeks

The change of skin redness

Chroma Meter MM500 was utilized to measure face skin redness. Units: a\* value

Time frame

Change from Baseline skin redness at 12 weeks

The change of skin melanin index

Mexameter® MX18 (CK, Germany) was utilized to measure face skin melanin level. Units: arbitrary units

Time frame

Change from Baseline skin melanin index at 12 weeks

The change of skin elasticity

Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity. Units: arbitrary units

Time frame

Change from Baseline skin elasticity at 12 weeks

Other outcomes

The change of self-assessment skin condition

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.

Time frame

Change from Baseline skin condition at 12 weeks

The change of self-assessment fatigue level

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.

Time frame

Change from Baseline fatigue level at 12 weeks

The change of self-assessment Low Immunity level

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.

Time frame

Change from Baseline Low Immunity level at 12 weeks

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

A fasting blood sample will be collected for liver function biomarkers testing.

Time frame

Change from Baseline liver function biomarkers at 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TCI Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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