Hair Loss
Conditions
Brief summary
To assess TCI999 on hair and body health care
Interventions
DIETARY_SUPPLEMENTTCI999 probiotic sachet
Testing product
DIETARY_SUPPLEMENTPlacebo sachet
Blank
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of hair loss amount | Change from Baseline hair loss amount at 12 weeks | Collected and measured the weight of loss hair |
| The change of hair density | Change from Baseline hair density at 12 weeks | Take a picture and observe the hair density |
| The change of hair follicle strength | Change from Baseline hair follicle strength at 12 weeks | 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 |
| The change of intestinal microbiota | Change from Baseline intestinal microbiota at 12 weeks | To evaluate the intestinal microbiota of fecal samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of dihydrotestosterone of blood | Change from Baseline hair diameter at 12 weeks | Venous blood was sampled to measure dihydrotestosterone |
| The change of testosterone of blood | Change from Baseline testosterone at 12 weeks | Venous blood was sampled to measure testosterone |
| The change of SRD5A1 gene expression of blood | Change from Baseline SRD5A1 gene expression at 12 weeks | Venous blood was sampled to measure SRD5A1 gene expression |
| The change of scalp health | Change from Baseline scalp health at 12 weeks | Soft Plus was utilized to measure hair diameter |
| The change of TGF-β gene expression of blood | Change from Baseline TGF-β gene expression at 12 weeks | Venous blood was sampled to measure TGF-β gene expression |
| The change of IGF-1 gene expression of blood | Change from Baseline IGF-1 gene expression at 12 weeks | Venous blood was sampled to measure IGF-1 gene expression |
| The change of AR gene expression of blood | Change from Baseline AR gene expression at 12 weeks | Venous blood was sampled to measure AR gene expression |
| The change of scalp redness | Change from Baseline scalp redness at 12 weeks | Chroma Meter MM500 was utilized to measure scalp redness |
| The change of scalp gloss | Change from Baseline scalp gloss at 12 weeks | Chroma Meter MM500 was utilized to measure scalp gloss |
| The change of hair diameter | Change from Baseline hair diameter at 12 weeks | Mitutoyo C/N293-100 was utilized to measure hair diameter |
Countries
Taiwan
Outcome results
None listed