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

NCT05013645 | Completed

• 1 other identifier: FSUIRB0188
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Skin

Keywords

Probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Skin microbiome analysis

  Study Days 1, 28

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

  Study Days 1, 14, 28, 35

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

  Study Days 1, 28

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

  Study Days 1, 14, 28, 35

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

  Study Days 1, 14, 28, 35

Study Arms (2)

Sterilized probiotic (LfQi601)

EXPERIMENTAL

Sterilized probiotic topically administered.

Other: Sterilized probiotic LfQi601

Gel control product

PLACEBO COMPARATOR

Inactive placebo.

Other: Placebo

Interventions

Sterilized probiotic LfQi601 OTHER

Sterilized probiotic topically administered.

Sterilized probiotic (LfQi601)

Placebo OTHER

Gel control product

Gel control product

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Dermatology Associates of Tallahassee: collaborator
• Quorum Innovations: collaborator

Study Sites (1)

Dermatology Associates of Tallahassee

Tallahassee, Florida, 32308, United States

Location

Study Officials

• Eva Berkes, MD

  Florida State University College of Medicine and Quorum Innovations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institutional Representative

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 19, 2021
• Study Start: May 22, 2019
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)