Skin ProblemsNCT03350893
Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
A study testing Emulsion base with probiotics and Emulsion base in people with 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 plantarum cream on skin health. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Problems
- What is being tested?
- Emulsion base with probiotics and Emulsion base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Sep 2017to 31 Aug 2018
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between the ages of 20-60.
Who cannot join
- Subjects with photosensitivity (Sun allergy).
- Subjects are undergoing medical therapy for skin diseases.
- Subjects with severe hyperpigmentation.
- Subjects with diabetes.
- Subjects with cosmetics allergy.
- Subjects who have recently participated laser therapies or other treatments are not suitable for sun.
Trial locations and contacts
1 site in 1 country.
About this study
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 plantarum cream on skin health.
Read the detailed description
To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.
- Conditions
- Skin Problems
- Being tested
- Emulsion base with probiotics, Emulsion base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emulsion base with probioticsCombination product
Also called Active Group
Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10^9 cells/ g-cream)
Emulsion baseOther
Also called Control Group
Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Emulsion base without probiotics Receives: Other: Emulsion base |
| Active Group | Experimental | Emulsion base with probiotics Receives: Combination Product: Emulsion base with probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Diagnosis
The changes of skin condition by VISIA Complexion Analysis System
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (2)
Skin Moisture
The changes of skin moisture by Skicon-200EX and Corneometer CM 825
Measured: Baseline, 4 weeks and 8 weeks
Skin Color
The changes of skin color by DermaSpectrometer
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start18 Sep 2017
- Primary completion25 Jul 2018
- Study completion31 Aug 2018
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel, Open Label Study
- Masking
- None (open label)
- Enrolment
- 20 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, Study chair, Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350893
- Sponsor's protocol ID
- 17-047-A2
- Status last verified
- Aug 2019
- First submitted
- 15 Nov 2017
- Last updated
- 16 Aug 2019
- 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 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
- ClinicalTrials.gov ID
- NCT03350893
- Acronym / sponsor ID
- 17-047-A2
- Conditions
- Skin Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chia Nan University of Pharmacy and Science
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Nov 2017 (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 plantarum cream on skin health.
Detailed description
To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face skin conditions such as moisturizing, whitening, anti-wrinkle and so on.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Parallel, Open Label Study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Emulsion baseEmulsion base without probiotics |
| Active Group | Experimental | Combination Product: Emulsion base with probioticsEmulsion base with probiotics |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers between the ages of 20-60.
Key exclusion criteria (6 listed)
- Subjects with photosensitivity (Sun allergy).
- Subjects are undergoing medical therapy for skin diseases.
- Subjects with severe hyperpigmentation.
- Subjects with diabetes.
- Subjects with cosmetics allergy.
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 |
|---|---|---|
| Emulsion base with probioticsAlso: Active GroupWater、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10^9 cells/ g-cream) | Combination product | Active Group |
| Emulsion baseAlso: Control GroupWater、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide | Other | Control Group |
Primary outcome
Skin Diagnosis
Time frame: Baseline, 4 weeks and 8 weeks
The changes of skin condition by VISIA Complexion Analysis System
2 secondary outcomes
Skin Moisture
Time frame: Baseline, 4 weeks and 8 weeks
Skin Color
Time frame: Baseline, 4 weeks and 8 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 16 Aug 2019.
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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 study chair
Chia Nan University of Pharmacy and Science, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emulsion base with probiotics and Emulsion base in people with 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 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 16 Aug 2019. 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?
Skin Diagnosis (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 16 Aug 2019.