Dry SkinDAMPNCT05013645
Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
A study testing Sterilized probiotic LfQi601 in people with Dry Skin, run by Florida State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- What is being tested?
- Sterilized probiotic LfQi601
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32308
About this study
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.
- Conditions
- Dry Skin
- Being tested
- Sterilized probiotic LfQi601, Placebo
- Keywords
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterilized probiotic LfQi601Other
Sterilized probiotic topically administered.
PlaceboOther
Gel control product
| Study group | Role | What they receive |
|---|---|---|
| Sterilized probiotic (LfQi601) | Experimental | Sterilized probiotic topically administered. Receives: Other: Sterilized probiotic LfQi601 |
| Gel control product | Placebo comparator | Inactive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneometer Measurements
Measures change in skin surface hydration at study days 1, 14, 28 and 35
Measured: Study Days 1, 14, 28, 35
Tewameter Measurements
Measures change in rate of skin surface water loss at study days 1, 14, 28, 35
Measured: Study Days 1, 14, 28, 35
Secondary outcomes (5)
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
Measured: Study Days 1, 28
Change in Skindex16 Quality of Life over study days 1, 14, 28, 35
Symptom-based scoring tool
Measured: 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
Measured: Study Days 1, 28
Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35
Symptom-based scoring tool
Measured: 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
Measured: Study Days 1, 14, 28, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start22 May 2019
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatology Associates of Tallahassee, Quorum Innovations
- Responsible party
- Principal investigator, Sharon Liebrich, Florida State University
- Investigators
- Eva Berkes, MD, Principal investigator, Florida State University College of Medicine and Quorum Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013645
- Sponsor's protocol ID
- FSUIRB0188
- Acronym
- DAMP
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
- ClinicalTrials.gov ID
- NCT05013645
- Acronym / sponsor ID
- DAMP / FSUIRB0188
- Conditions
- Dry Skin
- Keywords
- Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Dermatology Associates of Tallahassee, Quorum Innovations
- Study start
- 22 May 2019 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterilized probiotic (LfQi601) | Experimental | Other: Sterilized probiotic LfQi601Sterilized probiotic topically administered. |
| Gel control product | Placebo comparator | Other: PlaceboInactive placebo. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterilized probiotic LfQi601Sterilized probiotic topically administered. | Other | Sterilized probiotic (LfQi601) |
| PlaceboGel control product | Other | Gel control product |
Primary outcome
Corneometer Measurements
Time frame: Study Days 1, 14, 28, 35
Measures change in skin surface hydration at study days 1, 14, 28 and 35
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
5 secondary outcomes
Skin microbiome analysis
Time frame: Study Days 1, 28
Change in Skindex16 Quality of Life over study days 1, 14, 28, 35
Time frame: Study Days 1, 14, 28, 35
Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28
Time frame: Study Days 1, 28
Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35
Time frame: Study Days 1, 14, 28, 35
Change in Itchiness Self Assessment (I-VAS) over study days 1, 14, 28 and 35
Time frame: Study Days 1, 14, 28, 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Berkes, MD principal investigator
Florida State University College of Medicine and Quorum Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterilized probiotic LfQi601 in people with Dry Skin, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneometer Measurements (time frame: Study Days 1, 14, 28, 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.