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

Hair Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077553
• Other study ID #: 21-041-A
• Status: Completed
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2022
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess TCI999 on hair and body health care

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Hair Loss

Intervention

Dietary Supplement:
• TCI999 probiotic sachet
Testing product
• Placebo sachet
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Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of hair loss amount	Collected and measured the weight of loss hair	Change from Baseline hair loss amount at 12 weeks
Primary	The change of hair density	Take a picture and observe the hair density	Change from Baseline hair density at 12 weeks
Primary	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
Primary	The change of intestinal microbiota	To evaluate the intestinal microbiota of fecal samples	Change from Baseline intestinal microbiota at 12 weeks
Secondary	The change of scalp gloss	Chroma Meter MM500 was utilized to measure scalp gloss	Change from Baseline scalp gloss at 12 weeks
Secondary	The change of scalp redness	Chroma Meter MM500 was utilized to measure scalp redness	Change from Baseline scalp redness at 12 weeks
Secondary	The change of scalp health	Soft Plus was utilized to measure hair diameter	Change from Baseline scalp health at 12 weeks
Secondary	The change of hair diameter	Mitutoyo C/N293-100 was utilized to measure hair diameter	Change from Baseline hair diameter at 12 weeks
Secondary	The change of dihydrotestosterone of blood	Venous blood was sampled to measure dihydrotestosterone	Change from Baseline hair diameter at 12 weeks
Secondary	The change of testosterone of blood	Venous blood was sampled to measure testosterone	Change from Baseline testosterone at 12 weeks
Secondary	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
Secondary	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
Secondary	The change of TGF-ß gene expression of blood	Venous blood was sampled to measure TGF-ß gene expression	Change from Baseline TGF-ß gene expression at 12 weeks
Secondary	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