Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dermatology Associates of Tallahassee | UNKNOWN |
| Quorum Innovations | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterilized probiotic (LfQi601) | Experimental | Sterilized probiotic topically administered. |
|
| Gel control product | Placebo Comparator | Inactive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterilized probiotic LfQi601 | Other | Sterilized probiotic topically administered. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Berkes, MD | Florida State University College of Medicine and Quorum Innovations | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Associates of Tallahassee | Tallahassee | Florida | 32308 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Gel control product |
|
| 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 |