Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Serum in Healthy Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Microbial Colonization
- Sponsor
- BLIS Technologies Limited
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the face from a serum format in healthy adults.
Detailed Description
This is a randomized double-blind baseline controlled pilot study with no crossover for the assessment of any changes to the microbial make-up of the skin (The local skin microbiome), detection of colonization by the probiotic bacterium (BLIS Q24) on the skin and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Time Frame: Time Frame: 11 days post intervention
Study will determine the change in microbial composition following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.
Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Time Frame: Time Frame: 30 days post intervention
Study will determine the change in microbial composition following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 30 days across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.
Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Time Frame: Time Frame: 11 days post intervention
Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across one site with a level of significance of p\<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Time Frame: Time Frame: 11 days post intervention
Study will determine the change in skin quality parameters following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across one site with a level of significance of p\<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Time Frame: Time Frame: 30 days post intervention
Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 30 days across one site with a level of significance of p\<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in skin quality parameters post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
Time Frame: Time Frame: 7 days post last intervention
Study will determine the change in skin quality parameters following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (i.e. post 7 days from last application) across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Time Frame: Time Frame: 11 days post intervention
Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.
Change in skin quality parameters post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
Time Frame: Time Frame: 7 days post last intervention
Study will determine the change in skin quality parameters following the application of a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (i.e. post 7 days from last application) across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Time Frame: Time Frame: 30 days post intervention
Study will determine the change in skin quality parameters following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 30 days across one site with a level of significance of p\<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles.
Change in microbial composition post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
Time Frame: Time Frame: 7 days post last intervention
Study will determine the change in microbial composition following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (i.e. post 7 days from last application) across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Time Frame: Time Frame: 30 days post intervention
Study will determine the change in microbial composition following the application of a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 30 days across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.
Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
Time Frame: Time Frame: 7 days post last intervention
Study will determine the change in microbial composition following the application of a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (i.e. post 7 days from last application) across one site with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected.