Clinical trial NCT06706050: Clinical Therapeutic Potential of Novel Microbiome LP-51 on Xerosis Individual Based on Xerosis-microbiome Index
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Xerosis
Keywords: xerosis-microbiome index
Microbiome therapeutic
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Ministry of Trade, Industry and Energy
name: Soon Chun Hyang University
First posted: 2024-11-26
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of skin hydration and transepidermal water loss, and relieving pruritus
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Asan
country: Korea, Republic of
facility: Soonchunhyang University Probiotics Microbiome Convergence Center (PMC) Skin Clinical Evaluation Research Institute
state: Chungnumdo
Study officials:
References: