Atopic DermatitisPhase 1NCT01960764
Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival
A Phase 1 study testing Pre-Treatment with Dial liquid antibacterial soap in people with Atopic Dermatitis and Eczema, run by University of California, San Diego at 1 site in United States.
Trial summary
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Pre-Treatment with Dial liquid antibacterial soap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2022
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects who are not pregnant or lactating
- 18-80 years of age
- Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
- Presence of lesional atopic dermatitis skin in both antecubital fossae
- Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit
Who cannot join
- Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit
- Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit
- Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
- Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Show all 14Show fewer
- Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Active bacterial, viral or fungal skin infections
- Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic for up to four weeks prior to screening
- Use of any systemic immunosuppressive therapy (e.g. cyclosporine, methotrexate, etc.) within four weeks of screening.
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Division of Dermatology
San Diego, California, 92122
About this study
Official title: Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective antimicrobial Staphylococcal species such as Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the investigator will attempt to decrease S. aureus colonization and increase colonization by protective Staph species. First the investigator will culture the bacteria on subjects' lesional AD skin. The investigator will selectively grow the subject's antimicrobial Staph colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to both of the subject's arms. Prior to applying this, though, one arm will first be pre-treated with an antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare the abundance of antimicrobial Staph species on each subject's arms 24 hours later to determine whether the pre-treatment regimen increased survival of the transplanted antimicrobial Staph species. The investigator expects that the arm pre-treated with the antimicrobial regimen will have more antimicrobial Staph species at this time point.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Pre-Treatment with Dial liquid antibacterial soap, Control
- Keywords
- Autologous microbiome transplant, Bacteria transplant, Treatment for atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Treatment with Dial liquid antibacterial soapDrug
This arm will be pre-treated with Dial liquid antibacterial soap and alcohol prior to the autologous microbiome transplant.
ControlOther
Also called This arm will not be pre-treated, but rather will have the autologous microbiome transplant cream applied without any pre-treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Treatment | Experimental | Prior to receiving the transplant, this arm will be washed with an antimicrobial regimen Receives: Drug: Pre-Treatment with Dial liquid antibacterial soap |
| Control | Placebo comparator | This arm will still be transplanted with the autologous microbiome transplant cream, however it will not be pre-treated with an antimicrobial regimen Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abundance of antimicrobial Staph colonies
Quantitative washes will be used to measure the abundance of antimicrobial Staph colonies on both the pre-treated and the not pre-treated arms 24 hours after the microbial transplant
Measured: 24-hours post-transplant
Secondary outcomes (1)
Adverse events
All adverse events associated with use of the transplant cream will be recorded
Measured: 24 hours post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startJun 2016
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: This sub-study was not done because main study results reached significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Gallo, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960764
- Sponsor's protocol ID
- UCSD 131244.2
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2013
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival
- ClinicalTrials.gov ID
- NCT01960764
- Acronym / sponsor ID
- UCSD 131244.2
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Autologous microbiome transplant, Bacteria transplant, Treatment for atopic dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This sub-study was not done because main study results reached significance.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Oct 2013 (estimated)
- 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.
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective antimicrobial Staphylococcal species such as Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the investigator will attempt to decrease S. aureus colonization and increase colonization by protective Staph species. First the investigator will culture the bacteria on subjects' lesional AD skin. The investigator will selectively grow the subject's antimicrobial Staph colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to both of the subject's arms. Prior to applying this, though, one arm will first be pre-treated with an antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare the abundance of antimicrobial Staph species on each subject's arms 24 hours later to determine whether the pre-treatment regimen increased survival of the transplanted antimicrobial Staph species. The investigator expects that the arm pre-treated with the antimicrobial regimen will have more antimicrobial Staph species at this time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Treatment | Experimental | Drug: Pre-Treatment with Dial liquid antibacterial soapPrior to receiving the transplant, this arm will be washed with an antimicrobial regimen |
| Control | Placebo comparator | Other: ControlThis arm will still be transplanted with the autologous microbiome transplant cream, however it will not be pre-treated with an antimicrobial regimen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects who are not pregnant or lactating
- 18-80 years of age
- Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
- Presence of lesional atopic dermatitis skin in both antecubital fossae
- Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit
Key exclusion criteria (14 listed)
- Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit
- Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit
- Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
- Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in 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 |
|---|---|---|
| Pre-Treatment with Dial liquid antibacterial soapThis arm will be pre-treated with Dial liquid antibacterial soap and alcohol prior to the autologous microbiome transplant. | Drug | Pre-Treatment |
| ControlAlso: This arm will not be pre-treated, but rather will have the autologous microbiome transplant cream applied without any pre-treatment regimen. | Other | Control |
Primary outcome
Abundance of antimicrobial Staph colonies
Time frame: 24-hours post-transplant
Quantitative washes will be used to measure the abundance of antimicrobial Staph colonies on both the pre-treated and the not pre-treated arms 24 hours after the microbial transplant
1 secondary outcome
Adverse events
Time frame: 24 hours post-transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pre-Treatment with Dial liquid antibacterial soap in people with Atopic Dermatitis and Eczema, run by University of California, San Diego 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 14 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Abundance of antimicrobial Staph colonies (time frame: 24-hours post-transplant). 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 5 Nov 2020.