Skin ProblemsPhase 2NCT04566549
The Safety and Efficacy Evaluation of Hair Products Containing Probiotics
A Phase 2 study of Skin Problems, run by GenMont Biotech Incorporation at 1 site in Taiwan.
Trial summary
Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Problems
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jul 2020to 6 Feb 2021
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between the ages of 20-70.
Who cannot join
- Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
- Subjects with cosmetics allergy.
- Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
- Subjects with pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing of Hair Products Containing Probiotics
Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.
Read the detailed description
To evaluate the safety and efficacy of hair products containing probiotics
- Conditions
- Skin Problems
- Being tested
- Test group Probiotic Shampoo, Placebo group
- Keywords
- Hair health, Scalp health, Probiotics, Scalp microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group Probiotic ShampooCombination product
Also called Probiotic Group
Probiotic Shampoo
Placebo groupCombination product
Also called Control Group
Shampoo base
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Shampoo base without probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance. Receives: Combination Product: Placebo group |
| Test group | Active comparator | Shampoo base with probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance、Heat-killed Lactobacillus paracasei powders (5x10^8 cells/ g-shampoo). Receives: Combination Product: Test group Probiotic Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Microbiota
The changes of scalp microbiota will be evaluated by NGS or qPCR analysis at baseline and different timepoint post-intervention.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (6)
The sebum on scalp
The scalp sebum will be measured by Sebumeter SM815 (C+K, Germany) at baseline and different timepoint post-intervention.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
The scalp flakes (dandruff)
The scalp flakes will be evaluated by D-SQAME ® DANDRUFF TESTER at baseline and different timepoint post-intervention.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
The hair density (hairs/scalp area)
The hair number in a constant scalp area will be measured by Aramo TSII skin/hair diagnosis (Aramhuvis Co., Ltd. Korea) at baseline and different timepoint post-intervention.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
Adverse Event
Any adverse event, such as erythema,rash, itching and so on will be recorded during the intervention.
Measured: Baseline and 28 weeks
Single application closed patch epicutaneous test under occlusion
Probiotics on skin will be evaluated by Human Patch test. The Human Patch test method according to the Guidelines of Human Patch test Standards for Cosmetics, Taiwan Food and Drug Administration, 2019 edition.
Measured: 1 hour, 24 hours and 48 hour
Repeated application closed patch epicutaneous test under occlusion
The irritation potential of probiotics on skin will be evaluated by Human Patch test.
The Human Patch test method according to the Guidelines of Human Patch test Standards for Cosmetics, Taiwan Food and Drug Administration, 2019 edition.
Measured: Day 1, 2, 3, 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start6 Jul 2020
- Primary completion6 Dec 2020
- Study completion6 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ProblemsStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chia Nan University of Pharmacy and Science
- Responsible party
- Sponsor
- Investigators
- Ching-Gong Lin, PhD, Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566549
- Sponsor's protocol ID
- TSMH IRB 20-040-A
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Hair Products Containing Probiotics
- ClinicalTrials.gov ID
- NCT04566549
- Acronym / sponsor ID
- TSMH IRB 20-040-A
- Conditions
- Skin Problems
- Keywords
- Hair health, Scalp health, Probiotics, Scalp microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chia Nan University of Pharmacy and Science
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 28 Sep 2020 (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.
Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.
Detailed description
To evaluate the safety and efficacy of hair products containing probiotics
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Combination Product: Placebo groupShampoo base without probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance. |
| Test group | Active comparator | Combination Product: Test group Probiotic ShampooShampoo base with probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance、Heat-killed Lactobacillus paracasei powders (5x10^8 cells/ g-shampoo). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers between the ages of 20-70.
Key exclusion criteria (4 listed)
- Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
- Subjects with cosmetics allergy.
- Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
- Subjects with pregnancy or breast-feeding.
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 |
|---|---|---|
| Test group Probiotic ShampooAlso: Probiotic GroupProbiotic Shampoo | Combination product | Test group |
| Placebo groupAlso: Control GroupShampoo base | Combination product | Placebo group |
Primary outcome
Skin Microbiota
Time frame: Baseline, 4 weeks and 8 weeks
The changes of scalp microbiota will be evaluated by NGS or qPCR analysis at baseline and different timepoint post-intervention.
6 secondary outcomes
The sebum on scalp
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
The scalp flakes (dandruff)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
The hair density (hairs/scalp area)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
Adverse Event
Time frame: Baseline and 28 weeks
Single application closed patch epicutaneous test under occlusion
Time frame: 1 hour, 24 hours and 48 hour
Repeated application closed patch epicutaneous test under occlusion
Time frame: Day 1, 2, 3, 4 and 5
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 18 Aug 2021.
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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.
Ching-Gong Lin, PhD 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 Phase 2 study of Skin Problems, run by GenMont Biotech Incorporation 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 4 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 18 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Skin Microbiota (time frame: Baseline, 4 weeks and 8 weeks). 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 18 Aug 2021.