Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

Study Overview
=================
Brief Summary
-----------------
Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus plantarum cream on skin health.

Detailed Description
-----------------
To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.

Official Title
-----------------
Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin

Conditions
-----------------
Skin Problems

Intervention / Treatment
-----------------
* Combination Product: Emulsion base with probiotics
* Other: Emulsion base


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between the ages of 20-60. Exclusion Criteria: Subjects with photosensitivity (Sun allergy). Subjects are undergoing medical therapy for skin diseases. Subjects with severe hyperpigmentation. Subjects with diabetes. Subjects with cosmetics allergy. Subjects who have recently participated laser therapies or other treatments are not suitable for sun.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel, Open Label Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Emulsion base without probiotics | Other: Emulsion base<br>* Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide<br>* Other names: Control Group;|
| Experimental: Active Group<br>Emulsion base with probiotics | Combination Product: Emulsion base with probiotics<br>* Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10^9 cells/ g-cream)<br>* Other names: Active Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Diagnosis | The changes of skin condition by VISIA Complexion Analysis System | Baseline, 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Moisture | The changes of skin moisture by Skicon-200EX and Corneometer CM 825 | Baseline, 4 weeks and 8 weeks | 
| Skin Color | The changes of skin color by DermaSpectrometer | Baseline, 4 weeks and 8 weeks |