Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic

Florida State University20 enrolled

Overview

Double-blind placebo-controlled clinical trial to evaluate the effectiveness of a sterilized probiotic on skin health and hydration in adults with dry skin. The goal of the study is to determine if the addition of a skin-conditioning probiotic to a standard gel product will moisturize the skin, support a healthy skin microbiome, and be readily tolerated by adults with dry skin.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Dry Skin

Interventions

Sterilized probiotic LfQi601OTHER

Sterilized probiotic topically administered.

PlaceboOTHER

Gel control product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of a signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study 3. English-speaking 4. 18-90 years of age 5. Score of a 2 or higher in one of the four areas assessed on the Dry Skin Area and Severity Index (DASI) Exclusion Criteria: 1. Current self-reported pregnancy or active intent to conceive 2. Current lactation 3. Fever within 7 days of study enrollment 4. Self-reported use of systemic antibiotics (oral or injectable) in the past 6 weeks. 5. Any clinically significant medical or psychological disorder, condition, or disease that in the opinion of the investigator exposes the subject to unacceptable risk by participating in the study or interferes with the subject's ability to complete the study.

Locations (1)

Dermatology Associates of Tallahassee

Tallahassee, Florida, United States

Outcomes

Primary Outcomes

Corneometer Measurements

Measures change in skin surface hydration at study days 1, 14, 28 and 35

Time frame: Study Days 1, 14, 28, 35

Tewameter Measurements

Measures change in rate of skin surface water loss at study days 1, 14, 28, 35

Time frame: Study Days 1, 14, 28, 35

Secondary Outcomes

Skin microbiome analysis

Changes in the composition (abundance and diversity) of skin lesional microbiome communities between Days 1 and 28 as demonstrated by genomic region amplification and analysis of sterile skin swab sample using standard protocols to compare associated organisms between the 2 time points

Time frame: Study Days 1, 28

Change in Skindex16 Quality of Life over study days 1, 14, 28, 35

Symptom-based scoring tool

Time frame: Study Days 1, 14, 28, 35

Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28

Symptom-based scoring tool

Time frame: Study Days 1, 28

Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35

Symptom-based scoring tool

Time frame: Study Days 1, 14, 28, 35

Change in Itchiness Self Assessment (I-VAS) over study days 1, 14, 28 and 35

Symptoms-based scoring tool

Time frame: Study Days 1, 14, 28, 35

Data from ClinicalTrials.gov

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