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

Phase 1

Completed

• Conditions: Xerosis
• Interventions: Biological: Microbiome Therapeutic LP-51; Other: placebo cream (M23004-03)

• Registration Number: NCT06706050
• Lead Sponsor: Ho-Yeon Song

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Primary Completion: 2023-06-16
• Study Completion: 2023-11-06
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: LP-51	Microbiome Therapeutic LP-51	test substance was applied on participants
Arm 2: Placebo	placebo cream (M23004-03)	cream without active substance (M23004-03) was applied on the participants

Primary Outcome Measures

Name	Time	Method
Improvement of skin hydration and transepidermal water loss, and relieving pruritus	From enrollment to the end of treatment at 4 weeks	A 4-week double-blind clinical trial involving 43 participants suffering from xerosis was conducted to evaluate the therapeutic potential of Microbiome therapeutic LP51. To serve this purpose, Lactobarriome 5% cream containing LP51 culture filtrate was applied on the dry skin for 4-week. A random allocation chart (Simple Randomization method) was used to assign participants to the experimental group (test formulation) or control group (placebo).; The volunteers applied the product twice daily (morning and evening) to a 3 cm area proximal and distal to the crook of the designated arm. Clinical parameters were evaluated at baseline, after 2 weeks, and after 4 weeks of use. Visual assessments, subjective pruritus evaluations, skin hydration measurements, and TEWL measurements were conducted at every visit by a skin professional. Additionally, magnified photographs were taken using a Folliscope, and skin samples were collected to assess microbial changes after treatment.

Trial Locations

Locations (1)

Soonchunhyang University Probiotics Microbiome Convergence Center (PMC) Skin Clinical Evaluation Research Institute; 🇰🇷 Asan, Chungnumdo, Korea, Republic of