TCI999 in the Efficacy Verification Program of Hair and Body Health Care

Study Overview
=================
Brief Summary
-----------------
To assess TCI999 on hair and body health care

Official Title
-----------------
Lactobacillus Plantarum TCI999 in the Efficacy Verification Program of Hair and Body Health Care

Conditions
-----------------
Hair Loss

Intervention / Treatment
-----------------
* Dietary Supplement: TCI999 probiotic sachet
* Dietary Supplement: Placebo sachet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged above 20 years old Exclusion Criteria: Subject who is not willing to participate in this study. Patients with diseases of the skin, liver, kidney. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. Female who is pregnant or nursing or planning to become pregnant during the course of the study. The students taught by the PI. Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo sachet<br> | Dietary Supplement: Placebo sachet<br>* Blank<br>|
| Experimental: TCI999 probiotic sachet<br> | Dietary Supplement: TCI999 probiotic sachet<br>* Testing product<br>* Other names: Lactobacillus plantarum TCI999;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of hair loss amount | Collected and measured the weight of loss hair | Change from Baseline hair loss amount at 12 weeks | 
| The change of hair density | Take a picture and observe the hair density | Change from Baseline hair density at 12 weeks | 
| The change of hair follicle strength | Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area | Change from Baseline hair follicle strength at 12 weeks | 
| The change of intestinal microbiota | To evaluate the intestinal microbiota of fecal samples | Change from Baseline intestinal microbiota at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of scalp gloss | Chroma Meter MM500 was utilized to measure scalp gloss | Change from Baseline scalp gloss at 12 weeks | 
| The change of scalp redness | Chroma Meter MM500 was utilized to measure scalp redness | Change from Baseline scalp redness at 12 weeks | 
| The change of scalp health | Soft Plus was utilized to measure hair diameter | Change from Baseline scalp health at 12 weeks | 
| The change of hair diameter | Mitutoyo C/N293-100 was utilized to measure hair diameter | Change from Baseline hair diameter at 12 weeks | 
| The change of dihydrotestosterone of blood | Venous blood was sampled to measure dihydrotestosterone | Change from Baseline hair diameter at 12 weeks | 
| The change of testosterone of blood | Venous blood was sampled to measure testosterone | Change from Baseline testosterone at 12 weeks | 
| The change of SRD5A1 gene expression of blood | Venous blood was sampled to measure SRD5A1 gene expression | Change from Baseline SRD5A1 gene expression at 12 weeks | 
| The change of AR gene expression of blood | Venous blood was sampled to measure AR gene expression | Change from Baseline AR gene expression at 12 weeks | 
| The change of TGF-β gene expression of blood | Venous blood was sampled to measure TGF-β gene expression | Change from Baseline TGF-β gene expression at 12 weeks | 
| The change of IGF-1 gene expression of blood | Venous blood was sampled to measure IGF-1 gene expression | Change from Baseline IGF-1 gene expression at 12 weeks |