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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2023-11-15

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.

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Detailed Description

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Conditions

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Dry Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sterilized probiotic (LfQi601)

Sterilized probiotic topically administered.

Group Type EXPERIMENTAL

Sterilized probiotic LfQi601

Intervention Type OTHER

Sterilized probiotic topically administered.

Gel control product

Inactive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Gel control product

Interventions

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Sterilized probiotic LfQi601

Sterilized probiotic topically administered.

Intervention Type OTHER

Placebo

Gel control product

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes