Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-07-31

Brief Summary

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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 scalp from a serum format in healthy adults.

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Detailed Description

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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 on the scalp and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.

Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized double-blind baseline controlled pilot study with no crossover.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Both participants and investigator are blinded.

Study Groups

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Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose)

Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 colony forming units per application)

Group Type ACTIVE_COMPARATOR

Active Comparator: Study Group A: Blis Q24 Serum at higher dose

Intervention Type OTHER

Active Comparator: Study Group A: Blis Q24 Serum at 1e8 cfu/ dose (Active)

Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose)

Group : Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application)

Group Type ACTIVE_COMPARATOR

Active Comparator: Study Group B: Blis Q24 Serum at lower dose

Intervention Type OTHER

Active Comparator: Study Group A: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Interventions

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Active Comparator: Study Group A: Blis Q24 Serum at higher dose

Active Comparator: Study Group A: Blis Q24 Serum at 1e8 cfu/ dose (Active)

Intervention Type OTHER

Active Comparator: Study Group B: Blis Q24 Serum at lower dose

Active Comparator: Study Group A: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. In general, good health, is 18 - 80 years of age.
2. Practice good general body and hair hygiene.

Exclusion Criteria

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Free from any scalp disease, active cut, or open wound
3. On hair loss treatment at least 2 months prior to sampling.
4. Have used anti-dandruff shampoos on the scalp and hair for at least 1 week prior to the trial.
5. On concurrent antibiotic or antifungal therapy or regular antibiotic or antifungal. use within the last 1 week.
6. People with allergies or sensitivity to dairy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes