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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Skin

Intervention / Treatment
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* Other: Sterilized probiotic LfQi601
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of a signed and dated informed consent form Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study English-speaking 18-90 years of age Score of a 2 or higher in one of the four areas assessed on the Dry Skin Area and Severity Index (DASI) Exclusion Criteria: Current self-reported pregnancy or active intent to conceive Current lactation Fever within 7 days of study enrollment Self-reported use of systemic antibiotics (oral or injectable) in the past 6 weeks. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterilized probiotic (LfQi601)<br>Sterilized probiotic topically administered. | Other: Sterilized probiotic LfQi601<br>* Sterilized probiotic topically administered.<br>|
| Placebo Comparator: Gel control product<br>Inactive placebo. | Other: Placebo<br>* Gel control product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneometer Measurements | Measures change in skin surface hydration at study days 1, 14, 28 and 35 | Study Days 1, 14, 28, 35 | 
| Tewameter Measurements | Measures change in rate of skin surface water loss at study days 1, 14, 28, 35 | Study Days 1, 14, 28, 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Study Days 1, 28 | 
| Change in Skindex16 Quality of Life over study days 1, 14, 28, 35 | Symptom-based scoring tool | 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 | Study Days 1, 28 | 
| Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35 | Symptom-based scoring tool | 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 | Study Days 1, 14, 28, 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic