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

BLIS Technologies

Status: Enrolling

Conditions: Microbial Colonization

Treatments: Other: Placebo balm; Other: Micrococcus luteus Blis Q24 balm

Study type: Interventional

Funder types: Industry

Identifiers

NCT05750381

BLTCT2022/8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Study Group A: Blis Q24 balm (Active)

Active Comparator group

Description:

Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)

Treatment:

Other: Micrococcus luteus Blis Q24 balm

Study Group B: Placebo balm (without Blis Q24)

Placebo Comparator group

Description:

Group A: Placebo balm

Treatment:

Other: Placebo balm