Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.

Not Applicable

Recruiting

• Conditions: Microbial Colonization
• Interventions: Other: Micrococcus luteus Blis Q24 balm; Other: Placebo balm

• Registration Number: NCT05750381
• Lead Sponsor: BLIS Technologies Limited

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 elbow and back of forearm in a topical balm format in healthy adults.

Detailed Description

This is a randomized double-blind, placebo-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 colonisation 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 balm format.

Study Timeline

• Study Start: 2023-01-24
• Status Verified: 2023-02
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-03-10
• Study Completion: 2023-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• In general good health 18 - 80 years of age.
• Practice good general body hygiene

Exclusion Criteria

• Have a history of autoimmune disease or are immunocompromised.
• Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
• People with allergies or sensitivity to dairy.
• People with an open wound on the Blis Q24 application sites.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group A: Blis Q24 balm (Active)	Micrococcus luteus Blis Q24 balm	Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)
Study Group B: Placebo balm (without Blis Q24)	Placebo balm	Group A: Placebo balm

Primary Outcome Measures

Name	Time	Method
Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days	11 days post intervention	Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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.
Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days	7 days post last intervention	Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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.
Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days	11 days post last intervention	Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p\<0.05.
Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days	11 days post last intervention	Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p\<0.05.
Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days.	7 days post last intervention	Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p\<0.05.
Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days	11 days post intervention	Study will determine the change in microbial composition following the application of a balm containing Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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.
Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.	7 days post last intervention	Study will determine the change in microbial composition post 10 days application of Micrococcus luteus Q24 at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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.
Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.	7 days post last intervention	Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p\<0.05.

Trial Locations

Locations (1)

Blis Technologies Ltd; 🇳🇿 Dunedin, Otago, New Zealand