Hair LossNCT05077553
TCI999 in the Efficacy Verification Program of Hair and Body Health Care
A study testing TCI999 probiotic sachet in people with Hair Loss, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess TCI999 on hair and body health care Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hair Loss
- What is being tested?
- TCI999 probiotic sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged above 20 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Plantarum TCI999 in the Efficacy Verification Program of Hair and Body Health Care
To assess TCI999 on hair and body health care
- Conditions
- Hair Loss
- Being tested
- TCI999 probiotic sachet, Placebo sachet
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI999 probiotic sachetDietary supplement
Also called Lactobacillus plantarum TCI999
Testing product
Placebo sachetDietary supplement
Blank
| Study group | Role | What they receive |
|---|---|---|
| Placebo sachet | Placebo comparator | Not described Receives: Dietary Supplement: Placebo sachet |
| TCI999 probiotic sachet | Experimental | Not described Receives: Dietary Supplement: TCI999 probiotic sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of hair loss amount
Collected and measured the weight of loss hair
Measured: Change from Baseline hair loss amount at 12 weeks
The change of hair density
Take a picture and observe the hair density
Measured: 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
Measured: Change from Baseline hair follicle strength at 12 weeks
The change of intestinal microbiota
To evaluate the intestinal microbiota of fecal samples
Measured: Change from Baseline intestinal microbiota at 12 weeks
Secondary outcomes (10)
The change of scalp gloss
Chroma Meter MM500 was utilized to measure scalp gloss
Measured: Change from Baseline scalp gloss at 12 weeks
The change of scalp redness
Chroma Meter MM500 was utilized to measure scalp redness
Measured: Change from Baseline scalp redness at 12 weeks
The change of scalp health
Soft Plus was utilized to measure hair diameter
Measured: Change from Baseline scalp health at 12 weeks
The change of hair diameter
Mitutoyo C/N293-100 was utilized to measure hair diameter
Measured: Change from Baseline hair diameter at 12 weeks
The change of dihydrotestosterone of blood
Venous blood was sampled to measure dihydrotestosterone
Measured: Change from Baseline hair diameter at 12 weeks
The change of testosterone of blood
Venous blood was sampled to measure testosterone
Measured: Change from Baseline testosterone at 12 weeks
The change of SRD5A1 gene expression of blood
Venous blood was sampled to measure SRD5A1 gene expression
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline IGF-1 gene expression at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start17 Aug 2021
- Primary completion21 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Hua Liang, Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077553
- Sponsor's protocol ID
- 21-041-A
- Status last verified
- Mar 2022
- First submitted
- 1 Oct 2021
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Plantarum TCI999 in the Efficacy Verification Program of Hair and Body Health Care
- ClinicalTrials.gov ID
- NCT05077553
- Acronym / sponsor ID
- 21-041-A
- Conditions
- Hair Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess TCI999 on hair and body health care
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo sachet | Placebo comparator | Dietary Supplement: Placebo sachet |
| TCI999 probiotic sachet | Experimental | Dietary Supplement: TCI999 probiotic sachet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged above 20 years old
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCI999 probiotic sachetAlso: Lactobacillus plantarum TCI999Testing product | Dietary supplement | TCI999 probiotic sachet |
| Placebo sachetBlank | Dietary supplement | Placebo sachet |
Primary outcome
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
The change of hair density
Time frame: Change from Baseline hair density at 12 weeks
Take a picture and observe the hair density
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
The change of intestinal microbiota
Time frame: Change from Baseline intestinal microbiota at 12 weeks
To evaluate the intestinal microbiota of fecal samples
10 secondary outcomes
The change of scalp gloss
Time frame: Change from Baseline scalp gloss at 12 weeks
The change of scalp redness
Time frame: Change from Baseline scalp redness at 12 weeks
The change of scalp health
Time frame: Change from Baseline scalp health at 12 weeks
The change of hair diameter
Time frame: Change from Baseline hair diameter at 12 weeks
The change of dihydrotestosterone of blood
Time frame: Change from Baseline hair diameter at 12 weeks
The change of testosterone of blood
Time frame: Change from Baseline testosterone at 12 weeks
The change of SRD5A1 gene expression of blood
Time frame: Change from Baseline SRD5A1 gene expression at 12 weeks
The change of AR gene expression of blood
Time frame: Change from Baseline AR gene expression at 12 weeks
The change of TGF-β gene expression of blood
Time frame: Change from Baseline TGF-β gene expression at 12 weeks
The change of IGF-1 gene expression of blood
Time frame: Change from Baseline IGF-1 gene expression at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hua Liang principal investigator
Chia Nan University of Pharmacy ＆ Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI999 probiotic sachet in people with Hair Loss, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of hair loss amount (time frame: Change from Baseline hair loss amount at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.