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

NCT05077553 | Completed

• 1 other identifier: 21-041-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess TCI999 on hair and body health care

Conditions

Hair Loss

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• The change of scalp gloss

  Change from Baseline scalp gloss at 12 weeks

• The change of scalp redness

  Change from Baseline scalp redness at 12 weeks

• The change of scalp health

  Change from Baseline scalp health at 12 weeks

• The change of hair diameter

  Change from Baseline hair diameter at 12 weeks

• The change of dihydrotestosterone of blood

  Change from Baseline hair diameter at 12 weeks

Study Arms (2)

Placebo sachet

PLACEBO COMPARATOR

Dietary Supplement: Placebo sachet

TCI999 probiotic sachet

EXPERIMENTAL

Dietary Supplement: TCI999 probiotic sachet

Interventions

TCI999 probiotic sachet DIETARY_SUPPLEMENT

Testing product

Also known as: Lactobacillus plantarum TCI999

TCI999 probiotic sachet

Placebo sachet DIETARY_SUPPLEMENT

Blank

Placebo sachet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged above 20 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chia-Hua Liang

  Chia Nan University of Pharmacy ＆ Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: August 17, 2021
• Primary Completion: January 21, 2022
• Study Completion: March 31, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-03

Locations

TW (1)