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Completed

NCT Number: NCT05077553

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

To assess TCI999 on hair and body health care

Completed

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCI999 probiotic sachet

Dietary Supplement

Testing product

Other names: Lactobacillus plantarum TCI999

Placebo sachet

Dietary Supplement

Blank

Primary outcomes

  1. The change of hair loss amount

    Time frame: Change from Baseline hair loss amount at 12 weeks

    Collected and measured the weight of loss hair

  2. The change of hair density

    Time frame: Change from Baseline hair density at 12 weeks

    Take a picture and observe the hair density

  3. The change of hair follicle strength

    Time frame: 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

  4. The change of intestinal microbiota

    Time frame: Change from Baseline intestinal microbiota at 12 weeks

    To evaluate the intestinal microbiota of fecal samples

Secondary outcomes

  1. The change of scalp gloss

    Time frame: Change from Baseline scalp gloss at 12 weeks

    Chroma Meter MM500 was utilized to measure scalp gloss

  2. The change of scalp redness

    Time frame: Change from Baseline scalp redness at 12 weeks

    Chroma Meter MM500 was utilized to measure scalp redness

  3. The change of scalp health

    Time frame: Change from Baseline scalp health at 12 weeks

    Soft Plus was utilized to measure hair diameter

  4. The change of hair diameter

    Time frame: Change from Baseline hair diameter at 12 weeks

    Mitutoyo C/N293-100 was utilized to measure hair diameter

  5. The change of dihydrotestosterone of blood

    Time frame: Change from Baseline hair diameter at 12 weeks

    Venous blood was sampled to measure dihydrotestosterone

  6. The change of testosterone of blood

    Time frame: Change from Baseline testosterone at 12 weeks

    Venous blood was sampled to measure testosterone

  7. The change of SRD5A1 gene expression of blood

    Time frame: Change from Baseline SRD5A1 gene expression at 12 weeks

    Venous blood was sampled to measure SRD5A1 gene expression

  8. The change of AR gene expression of blood

    Time frame: Change from Baseline AR gene expression at 12 weeks

    Venous blood was sampled to measure AR gene expression

  9. The change of TGF-β gene expression of blood

    Time frame: Change from Baseline TGF-β gene expression at 12 weeks

    Venous blood was sampled to measure TGF-β gene expression

  10. The change of IGF-1 gene expression of blood

    Time frame: Change from Baseline IGF-1 gene expression at 12 weeks

    Venous blood was sampled to measure IGF-1 gene expression

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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