Clinical Therapeutic Potential of Novel Microbiome LP-51 on Xerosis Individual Based on Xerosis-microbiome Index

Ho-Yeon Song

Status and phase: Completed; Phase 2; Phase 1

Conditions: Xerosis

Treatments: Biological: Microbiome Therapeutic LP-51; Other: placebo cream (M23004-03)

Study type: Interventional

Funder types: Other

Identifiers

NCT06706050

S23004-01

Details and patient eligibility

About

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).

Enrollment: 43 patients

Sex: All

Ages: 21 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Pregnant or lactating women
• Those planning pregnancy during the trial period
• Any other factors deemed unsuitable by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups, including a placebo group

Arm 1: LP-51

Experimental group

Description:

test substance was applied on participants

Treatment:

Biological: Microbiome Therapeutic LP-51

Arm 2: Placebo

Placebo Comparator group

Description:

cream without active substance (M23004-03) was applied on the participants

Treatment:

Other: placebo cream (M23004-03)