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

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 Overview

• Status: Completed
• Conditions: Dry Skin
• Intervention / Treatment: Other: Sterilized probiotic LfQi601; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Dermatology Associates of Tallahassee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sterilized probiotic (LfQi601); Sterilized probiotic topically administered.	Other: Sterilized probiotic LfQi601; Sterilized probiotic topically administered.
Placebo Comparator: Gel control product; Inactive placebo.	Other: Placebo; Gel control product

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Dermatology Associates of Tallahassee; Quorum Innovations
• Investigators: Principal Investigator: Eva Berkes, MD, Florida State University College of Medicine and Quorum Innovations

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Probiotic
• Other Study ID Numbers: FSUIRB0188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No