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

Sponsor
Florida State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05013645
Collaborator
Dermatology Associates of Tallahassee (Other), Quorum Innovations (Other)
50
Enrollment
1
Location
2
Arms
41.8
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sterilized probiotic LfQi601
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
Actual Study Start Date :
May 22, 2019
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Corneometer Measurements [Study Days 1, 14, 28, 35]

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

  2. Tewameter Measurements [Study Days 1, 14, 28, 35]

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

Secondary Outcome Measures

  1. Skin microbiome analysis [Study Days 1, 28]

    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

  2. Change in Skindex16 Quality of Life over study days 1, 14, 28, 35 [Study Days 1, 14, 28, 35]

    Symptom-based scoring tool

  3. Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28 [Study Days 1, 28]

    Symptom-based scoring tool

  4. Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35 [Study Days 1, 14, 28, 35]

    Symptom-based scoring tool

  5. Change in Itchiness Self Assessment (I-VAS) over study days 1, 14, 28 and 35 [Study Days 1, 14, 28, 35]

    Symptoms-based scoring tool

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dermatology Associates of Tallahassee Tallahassee Florida United States 32308

Sponsors and Collaborators

  • Florida State University
  • Dermatology Associates of Tallahassee
  • Quorum Innovations

Investigators

  • Principal Investigator: Eva Berkes, MD, Florida State University College of Medicine and Quorum Innovations

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eva Berkes, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT05013645
Other Study ID Numbers:
  • FSUIRB0188
First Posted:
Aug 19, 2021
Last Update Posted:
Apr 27, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eva Berkes, Principal Investigator, Florida State University
Probiotic

Study Results

No Results Posted as of Apr 27, 2022