Dry Skin
Conditions
Keywords
Probiotic
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.
Interventions
OTHERSterilized probiotic LfQi601
Sterilized probiotic topically administered.
OTHERPlacebo
Gel control product
Sponsors
Dermatology Associates of Tallahassee
Quorum Innovations
Florida State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneometer Measurements | Study Days 1, 14, 28, 35 | Measures change in skin surface hydration at study days 1, 14, 28 and 35 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28 | Study Days 1, 28 | Symptom-based scoring tool |
| 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 |
| 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 |
| 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 |
| Change in Skindex16 Quality of Life over study days 1, 14, 28, 35 | Study Days 1, 14, 28, 35 | Symptom-based scoring tool |
Countries
United States
Outcome results
None listed