NCT06706050

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

Clinical Evaluation of Lactobarriome 5% Cream's Efficacy on Dry Skin for Improving Skin Hydration and Transepidermal Water Loss, Relieving Pruritus, and Altering the Skin Microbiome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Ho-Yeon Song · Academic / Other
• Sex: All
• Age: 21 Years – 61 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Xerosis

Interventions

Type	Name	Description
BIOLOGICAL	Microbiome Therapeutic LP-51	Microbiome therapeutics LP-51 was applied on the individuals suffering from xerosis
OTHER	placebo cream (M23004-03)	placebo cream (M23004-03) was applied on the participants

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-06-16
• Completion: 2023-11-06
• First posted: 2024-11-26
• Last updated: 2024-11-26

Locations

1 site across 1 country: South Korea