XerosisPhase 1/2NCT06706050
Clinical Therapeutic Potential of Novel Microbiome LP-51 on Xerosis Individual Based on Xerosis-microbiome Index
A Phase 1/2 study testing Microbiome Therapeutic LP-51 in people with Xerosis, run by Ho-Yeon Song at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a Lactobacillus sp. Read more about this study
- Who is it for?
- Ages 21 to 61 years
- Conditions the study is for
- Xerosis
- What is being tested?
- Microbiome Therapeutic LP-51
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2023to 6 Nov 2023
- Phase
- Phase 1/2
- 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 21 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy participants, including men and women, aged 19-70
- Without acute or chronic diseases (excluding atopic dermatitis)
- Individuals suffering from dry skin and itchiness in the test area (crook of the arm)
- Those with objectively proven skin barrier damage demonstrated by a transepidermal water loss (TEWL) value of ≥12 g/h/m² and a skin hydration value below 35 (Corneometer measurement)
- Individuals who provided voluntary informed consent
- Those who agreed to comply with study visits and observations
Who cannot join
- Individuals with active skin diseases requiring treatment
- Those with an ESIF score >6
- Individuals with a history of antibiotic, steroid, immunosuppressant, antihistamine, or retinoid use, or phototherapy within the last 4 weeks
- Individuals who used skin disease-related supplements or moisturizers within 2 weeks
- Those participating in other clinical trials within the last 4 weeks
- Individuals with frequent exposure to UV light
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- Pregnant or lactating women
- Those planning pregnancy during the trial period
- Any other factors deemed unsuitable by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Probiotics Microbiome Convergence Center (PMC) Skin Clinical Evaluation Research Institute
Asan, Chungnumdo, 31538
About this study
Official title: Clinical Evaluation of Lactobarriome 5% Cream's Efficacy on Dry Skin for Improving Skin Hydration and Transepidermal Water Loss, Relieving Pruritus, and Altering the Skin Microbiome
The purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a Lactobacillus sp. product (Lactobarriome 5% cream) compared to a placebo cream to prove the skin improvement effects of Lactobarriome 5%, which is a nature-friendly material derived from intravaginal microflora that can replace chemical components commonly used as ingredients for existing cosmetics.
The impact of Lactobarriome 5% cream, formulated with LP51 culture filtrate, on dry skin was assessed through a 4-week double-blind clinical trial. Participants were selected based on predefined inclusion and exclusion criteria. Using a simple randomization method, participants were assigned to either the experimental group (receiving the test formulation) or the control group (receiving a placebo). The products were applied twice daily-morning and evening-to a 3 cm area on both the proximal and distal sides of the designated arm's crook. Clinical evaluations were conducted at baseline, as well as after 2 weeks and 4 weeks of product use. These assessments included visual inspections, subjective pruritus evaluations, skin hydration levels, and transepidermal water loss (TEWL) measurements, all performed by a skincare professional. Furthermore, magnified images were captured using a Folliscope, and skin samples were collected to analyze microbial changes post-treatment. Before application, the designated arm was washed with water and allowed to rest for 30 minutes under controlled conditions (22±2°C, 50±10% relative humidity).
- Conditions
- Xerosis
- Being tested
- Microbiome Therapeutic LP-51, placebo cream (M23004-03)
- Keywords
- xerosis-microbiome index, Microbiome therapeutic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome Therapeutic LP-51Biological
Microbiome therapeutics LP-51 was applied on the individuals suffering from xerosis
placebo cream (M23004-03)Other
placebo cream (M23004-03) was applied on the participants
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: LP-51 | Experimental | test substance was applied on participants Receives: Biological: Microbiome Therapeutic LP-51 |
| Arm 2: Placebo | Placebo comparator | cream without active substance (M23004-03) was applied on the participants Receives: Other: placebo cream (M23004-03) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of skin hydration and transepidermal water loss, and relieving pruritus
A 4-week double-blind clinical trial involving 43 participants suffering from xerosis was conducted to evaluate the therapeutic potential of Microbiome therapeutic LP51. To serve this purpose, Lactobarriome 5% cream containing LP51 culture filtrate was applied on the dry skin for 4-week. A random allocation chart (Simple Randomization method) was used to assign participants to the experimental group (test formulation) or control group (placebo).
The volunteers applied the product twice daily (morning and evening) to a 3 cm area proximal and distal to the crook of the designated arm. Clinical parameters were evaluated at baseline, after 2 weeks, and after 4 weeks of use. Visual assessments, subjective pruritus evaluations, skin hydration measurements, and TEWL measurements were conducted at every visit by a skin professional. Additionally, magnified photographs were taken using a Folliscope, and skin samples were collected to assess microbial changes after treatment.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start8 May 2023
- Primary completion16 Jun 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ho-Yeon Song
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, Ministry of Trade, Industry and Energy, Soon Chun Hyang University
- Responsible party
- Sponsor-investigator, Ho-Yeon Song, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706050
- Sponsor's protocol ID
- S23004-01
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lactobarriome 5% Cream's Efficacy on Dry Skin for Improving Skin Hydration and Transepidermal Water Loss, Relieving Pruritus, and Altering the Skin Microbiome
- ClinicalTrials.gov ID
- NCT06706050
- Acronym / sponsor ID
- S23004-01
- Conditions
- Xerosis
- Keywords
- xerosis-microbiome index, Microbiome therapeutic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ho-Yeon SongUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, Ministry of Trade, Industry and Energy, Soon Chun Hyang University
- Study start
- 8 May 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 26 Nov 2024 (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.
The purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a Lactobacillus sp. product (Lactobarriome 5% cream) compared to a placebo cream to prove the skin improvement effects of Lactobarriome 5%, which is a nature-friendly material derived from intravaginal microflora that can replace chemical components commonly used as ingredients for existing cosmetics.
The impact of Lactobarriome 5% cream, formulated with LP51 culture filtrate, on dry skin was assessed through a 4-week double-blind clinical trial. Participants were selected based on predefined inclusion and exclusion criteria. Using a simple randomization method, participants were assigned to either the experimental group (receiving the test formulation) or the control group (receiving a placebo). The products were applied twice daily-morning and evening-to a 3 cm area on both the proximal and distal sides of the designated arm's crook. Clinical evaluations were conducted at baseline, as well as after 2 weeks and 4 weeks of product use. These assessments included visual inspections, subjective pruritus evaluations, skin hydration levels, and transepidermal water loss (TEWL) measurements, all performed by a skincare professional. Furthermore, magnified images were captured using a Folliscope, and skin samples were collected to analyze microbial changes post-treatment. Before application, the designated arm was washed with water and allowed to rest for 30 minutes under controlled conditions (22±2°C, 50±10% relative humidity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: LP-51 | Experimental | Biological: Microbiome Therapeutic LP-51test substance was applied on participants |
| Arm 2: Placebo | Placebo comparator | Other: placebo cream (M23004-03)cream without active substance (M23004-03) was applied on the participants |
Who may qualify
- Ages
- 21 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy participants, including men and women, aged 19-70
- Without acute or chronic diseases (excluding atopic dermatitis)
- Individuals suffering from dry skin and itchiness in the test area (crook of the arm)
- Those with objectively proven skin barrier damage demonstrated by a transepidermal water loss (TEWL) value of ≥12 g/h/m² and a skin hydration value below 35 (Corneometer measurement)
- Individuals who provided voluntary informed consent
Key exclusion criteria (9 listed)
- Individuals with active skin diseases requiring treatment
- Those with an ESIF score >6
- Individuals with a history of antibiotic, steroid, immunosuppressant, antihistamine, or retinoid use, or phototherapy within the last 4 weeks
- Individuals who used skin disease-related supplements or moisturizers within 2 weeks
- Those participating in other clinical trials within the last 4 weeks
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 |
|---|---|---|
| Microbiome Therapeutic LP-51Microbiome therapeutics LP-51 was applied on the individuals suffering from xerosis | Biological | Arm 1: LP-51 |
| placebo cream (M23004-03)placebo cream (M23004-03) was applied on the participants | Other | Arm 2: Placebo |
Primary outcome
Improvement of skin hydration and transepidermal water loss, and relieving pruritus
Time frame: From enrollment to the end of treatment at 4 weeks
A 4-week double-blind clinical trial involving 43 participants suffering from xerosis was conducted to evaluate the therapeutic potential of Microbiome therapeutic LP51. To serve this purpose, Lactobarriome 5% cream containing LP51 culture filtrate was applied on the dry skin for 4-week. A random allocation chart (Simple Randomization method) was used to assign participants to the experimental group (test formulation) or control group (placebo). The volunteers applied the product twice daily (morning and evening) to a 3 cm area proximal and distal to the crook of the designated arm. Clinical parameters were evaluated at baseline, after 2 weeks, and after 4 weeks of use. Visual assessments, subjective pruritus evaluations, skin hydration measurements, and TEWL measurements were conducted at every visit by a skin professional. Additionally, magnified photographs were taken using a Folliscope, and skin samples were collected to assess microbial changes after treatment.
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 26 Nov 2024.
- Individual participant dataSharing planned: Yes
Related trials for Xerosis
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Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
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Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
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Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Microbiome Therapeutic LP-51 in people with Xerosis, run by Ho-Yeon Song at 1 site in South Korea.
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 6 inclusion and 9 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 26 Nov 2024. 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 South Korea. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Improvement of skin hydration and transepidermal water loss, and relieving pruritus (time frame: From enrollment to the end of treatment at 4 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 26 Nov 2024.