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

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

To assess TCI999 on hair and body health care

Study Overview

• Status: Completed
• Conditions: Hair Loss
• Intervention / Treatment: Dietary supplement: Placebo sachet; Dietary supplement: TCI999 probiotic sachet

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 71710
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo sachet	Dietary supplement: Placebo sachet; Blank
Experimental: TCI999 probiotic sachet	Dietary supplement: TCI999 probiotic sachet; Testing product; 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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: 21-041-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No