Back to resultsTCI999 in the Efficacy Verification Program of Hair and Body Health Care
Primary Purpose
Hair Loss
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TCI999 probiotic sachet
Placebo sachet
Sponsored by
About this trial
This is an interventional other trial for Hair Loss
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
Sites / Locations
- Chia Nan University of Pharmacy ＆ Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo sachet
TCI999 probiotic sachet
Arm Description
Outcomes
Primary Outcome Measures
The change of hair loss amount
Collected and measured the weight of loss hair
The change of hair density
Take a picture and observe the hair density
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
The change of intestinal microbiota
To evaluate the intestinal microbiota of fecal samples
Secondary Outcome Measures
The change of scalp gloss
Chroma Meter MM500 was utilized to measure scalp gloss
The change of scalp redness
Chroma Meter MM500 was utilized to measure scalp redness
The change of scalp health
Soft Plus was utilized to measure hair diameter
The change of hair diameter
Mitutoyo C/N293-100 was utilized to measure hair diameter
The change of dihydrotestosterone of blood
Venous blood was sampled to measure dihydrotestosterone
The change of testosterone of blood
Venous blood was sampled to measure testosterone
The change of SRD5A1 gene expression of blood
Venous blood was sampled to measure SRD5A1 gene expression
The change of AR gene expression of blood
Venous blood was sampled to measure AR gene expression
The change of TGF-β gene expression of blood
Venous blood was sampled to measure TGF-β gene expression
The change of IGF-1 gene expression of blood
Venous blood was sampled to measure IGF-1 gene expression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05077553
Brief Title
TCI999 in the Efficacy Verification Program of Hair and Body Health Care
Official Title
Lactobacillus Plantarum TCI999 in the Efficacy Verification Program of Hair and Body Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess TCI999 on hair and body health care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo sachet
Arm Type
Placebo Comparator
Arm Title
TCI999 probiotic sachet
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI999 probiotic sachet
Other Intervention Name(s)
Lactobacillus plantarum TCI999
Intervention Description
Testing product
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo sachet
Intervention Description
Blank
Primary Outcome Measure Information:
Title
The change of hair loss amount
Description
Collected and measured the weight of loss hair
Time Frame
Change from Baseline hair loss amount at 12 weeks
Title
The change of hair density
Description
Take a picture and observe the hair density
Time Frame
Change from Baseline hair density at 12 weeks
Title
The change of hair follicle strength
Description
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
Time Frame
Change from Baseline hair follicle strength at 12 weeks
Title
The change of intestinal microbiota
Description
To evaluate the intestinal microbiota of fecal samples
Time Frame
Change from Baseline intestinal microbiota at 12 weeks
Secondary Outcome Measure Information:
Title
The change of scalp gloss
Description
Chroma Meter MM500 was utilized to measure scalp gloss
Time Frame
Change from Baseline scalp gloss at 12 weeks
Title
The change of scalp redness
Description
Chroma Meter MM500 was utilized to measure scalp redness
Time Frame
Change from Baseline scalp redness at 12 weeks
Title
The change of scalp health
Description
Soft Plus was utilized to measure hair diameter
Time Frame
Change from Baseline scalp health at 12 weeks
Title
The change of hair diameter
Description
Mitutoyo C/N293-100 was utilized to measure hair diameter
Time Frame
Change from Baseline hair diameter at 12 weeks
Title
The change of dihydrotestosterone of blood
Description
Venous blood was sampled to measure dihydrotestosterone
Time Frame
Change from Baseline hair diameter at 12 weeks
Title
The change of testosterone of blood
Description
Venous blood was sampled to measure testosterone
Time Frame
Change from Baseline testosterone at 12 weeks
Title
The change of SRD5A1 gene expression of blood
Description
Venous blood was sampled to measure SRD5A1 gene expression
Time Frame
Change from Baseline SRD5A1 gene expression at 12 weeks
Title
The change of AR gene expression of blood
Description
Venous blood was sampled to measure AR gene expression
Time Frame
Change from Baseline AR gene expression at 12 weeks
Title
The change of TGF-β gene expression of blood
Description
Venous blood was sampled to measure TGF-β gene expression
Time Frame
Change from Baseline TGF-β gene expression at 12 weeks
Title
The change of IGF-1 gene expression of blood
Description
Venous blood was sampled to measure IGF-1 gene expression
Time Frame
Change from Baseline IGF-1 gene expression at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy ＆ Science
City
Tainan
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
TCI999 in the Efficacy Verification Program of Hair and Body Health Care
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