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

Dry Skin Clinical Trial

— DAMP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05013645
• Other study ID #: FSUIRB0188
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Skin

Intervention

Other:
• Sterilized probiotic LfQi601
Sterilized probiotic topically administered.
• Placebo
Gel control product

Locations

Country	Name	City	State
United States	Dermatology Associates of Tallahassee	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	Dermatology Associates of Tallahassee, Quorum Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneometer Measurements	Measures change in skin surface hydration at study days 1, 14, 28 and 35	Study Days 1, 14, 28, 35
Primary	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	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
Secondary	Change in Skindex16 Quality of Life over study days 1, 14, 28, 35	Symptom-based scoring tool	Study Days 1, 14, 28, 35
Secondary	Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28	Symptom-based scoring tool	Study Days 1, 28
Secondary	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
Secondary	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