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Completed

NCT Number: NCT05013645

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

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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Key information

Conditions

Dry Skin

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Associates of Tallahassee

Tallahassee, Florida, 32308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sterilized probiotic LfQi601

Other

Sterilized probiotic topically administered.

Placebo

Other

Gel control product

Primary outcomes

  1. Corneometer Measurements

    Time frame: Study Days 1, 14, 28, 35

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

  2. Tewameter Measurements

    Time frame: Study Days 1, 14, 28, 35

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

Secondary outcomes

  1. Skin microbiome analysis

    Time frame: 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

    Time frame: 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

    Time frame: Study Days 1, 28

    Symptom-based scoring tool

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

    Time frame: 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

    Time frame: Study Days 1, 14, 28, 35

    Symptoms-based scoring tool

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Dermatology Associates of Tallahassee
  • Quorum Innovations

Registry information

Acronym: DAMP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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