Atopic DermatitisPhase 1TIME-1NCT05177328
Targeted Investigation of Microbiome Elimination
A Phase 1 study testing S. hominis A 9 Product in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to examine the pharmacokinetics or survival of new product containing commensal infection fighting bacteria, on the skin of patients with Atopic Dermatitis (AD), after a single application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- S. hominis A 9 Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 13 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant must be able to understand and provide informed consent
- Meet Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria for active atopic dermatitis (AD)
- At least 21 cm^2 of lesional and 21 cm^2 of non-lesional skin on both the right and left ventral arms. The required area (lesional or non-lesional) may be one contiguous area or may encompass multiple areas with a total cumulative area of 21 cm^2
- An Investigator Global Assessment (IGA) score, on the ventral arms of at least moderate severity
- Body surface area (BSA), as measured by Mostellar BSA Calculator, between 1.26 m^2 and 2.25 m^2
- If female of child bearing potential, must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception (e.g. oral contraceptives, intrauterine device [IUD], barrier method with spermicide, or surgically sterilized partner, Depo- Provera, Norplant, NuvaRing, or hormonal implants) for the duration of study participation
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Pregnant or lactating females
- Active bacterial, viral, or fungal skin infections
- Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Cetaphil® Lotion, alcohol-based cleaners, glycerol, or soy products
- Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Show all 21Show fewer
- Any participant who is immunocompromised (e.g. history of lymphoma, Human Immunodeficiency Virus [HIV]/Acquired Immunodeficiency Syndrome [AIDS], Wiskott-Aldrich Syndrome), has an immune system disorder (e.g. autoimmune disease), or is using a systemic immunosuppressant (e.g. systemic corticosteroids, cyclosporine, methotrexate)
- Any participant with current malignant disease (with the exception of non-melanoma skin cancer in an area not affected by treatment)
- Participants 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
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or 5 half-lives (if known), whichever is longer, of the Screening Visit
- Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit
- Treatment with Dupilumab within 16 weeks of the Screening Visit
- Treatment with oral or injectable therapy for AD (excluding oral steroids) within 5 half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer
- Participants with close contacts (e.g. spouse, children, or members in the same household) that have severe barrier defects or are immunocompromised
- Use of topical (including steroids and calcineurin inhibitors) AD treatments on the ventral arms or face within 7 days of the Treatment Visit; Use of topical steroids on areas outside of where investigational product is to be applied or swabbing is to be performed may be permitted, per investigator discretion
- Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair(R), MimyX(R), Epiceram(R), etc.) on the ventral arms or face within 7 days of the Treatment Visit; Use on areas outside of where investigational product is to be applied or swabbing is to be performed is permitted
- Use of any oral or topical antibiotic within 7 days of the Treatment Visit
- Participants who have taken a bleach bath within 7 days of the Treatment Visit
- Use of any oral steroid therapies within 28 days of the Treatment Visit
- Any phototherapy for skin disease (such as narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or regular use (more than 2 visits per week) of a tanning bed within 28 days of the Treatment Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego: Dermatology Clinical Trials Unit
La Jolla, California, 92093
About this study
Official title: A Pilot Study to Evaluate the Survival of Transplanted Staphylococcus Hominis A9 on the Skin of Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-13)
The purpose of this study is to examine the pharmacokinetics or survival of new product containing commensal infection fighting bacteria, on the skin of patients with Atopic Dermatitis (AD), after a single application.
Read the detailed description
This study will enroll a minimum of 20 participants, 18-80 years of age, with moderate-to-severe atopic dermatitis (AD) on their ventral arms. A minimum of 13 participants will have a positive Staphylococcus aureus (S. aureus) colonized lesion on both upper extremities. A minimum of 7 participants will have a negative S. aureus colonized lesion on both upper extremities.
The participant's colonization status will be determined from cultures taken during a pre-treatment phase, approximately 7 days prior to receiving study treatment on Day 0. On Day 0, skin swabs will be collected from lesional and non-lesional sites (at least 21cm^2) on the participant's right and left ventral arms and one non-lesional site on the participant's face. After the skin swab collections, the participant will have ShA9 applied to their right or left ventral arm and placebo applied to their contralateral ventral arm. The assignment of ShA9 and placebo to the dominant and non-dominant arms will be randomized. Additional swabs will be collected 15 minutes, and 1, 2, 4, and 6 hours after the ShA9 and placebo applications on Day 0.
Participants will be asked to return to the clinic 24 hours after receiving their single application and again on Days 3, 10, 17, and 24 for the assessment of adverse events (AEs) and the collection of skin swabs from the identified lesional and non-lesional sites, as needed. After the Day 3 visit, a participant will not be required to complete the Day 10, 17, and 24 visits if their lesional swabs are negative for Coagulase Negative Staphylococcal Species (CoNS).
All randomized participants will complete a final End of Study Phone visit on Day 31 to assess for adverse events and status of their AD.
- Conditions
- Atopic Dermatitis
- Being tested
- S. hominis A 9 Product, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. hominis A 9 ProductBiological
Also called ShA9
Commensal staph species, phosphate buffered saline, and glycerol.
PlaceboDrug
Also called Placebo for S. hominis A 9 Product
Phosphate buffered saline and glycerol
| Study group | Role | What they receive |
|---|---|---|
| ShA9 | Experimental | All participants will receive ShA9 active treatment on one of their ventral arms and placebo on their contralateral arm. The assignment of ShA9 and placebo to the dominant and non-dominant arms will be randomized. Receives: Biological: S. hominis A 9 Product; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Duration of ShA9 Survival on the Lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).
Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). The primary endpoint was assessed based on samples from lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.
Measured: Day 0 to Day 24
Secondary outcomes (3)
The Duration of ShA9 Survival on the Non-lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).
Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). This secondary endpoint was assessed based on samples from non-lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.
Measured: Day 0 to Day 24
The Count of Serious Treatment-emergent Adverse Events Per Participant.
For this study, an adverse event included any untoward or unfavorable medical occurrence associated with the study treatment regimen or study mandated procedures. An adverse event was considered 'serious' if, in the view of the investigator or Sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measured: Day 0 to Day 31
The Count of Non-serious Treatment-emergent Adverse Events Per Participant.
For this study, an adverse event included any untoward or unfavorable medical occurrence associated with the study treatment regimen or study mandated procedures. An adverse event was considered 'non-serious' if it did not result in any of the serious defined outcomes.
Measured: Day 0 to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start18 Jul 2022
- Primary completion27 Aug 2023
- Study completion13 Oct 2023
Why it stopped: Decision to terminate enrollment early was made by the protocol chair and NIAID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Responsible party
- Sponsor
- Investigators
- Richard Gallo, M.D., Ph.D., Study chair, University of California, San Diego: Dermatology Clinical Trials UnitTissa Hata, M.D., Study chair, University of California, San Diego: Dermatology Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177328
- Sponsor's protocol ID
- DAIT ADRN-13
- Acronym
- TIME-1
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2021
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Survival of Transplanted Staphylococcus Hominis A9 on the Skin of Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-13)
- ClinicalTrials.gov ID
- NCT05177328
- Acronym / sponsor ID
- TIME-1 / DAIT ADRN-13
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to terminate enrollment early was made by the protocol chair and NIAID
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the pharmacokinetics or survival of new product containing commensal infection fighting bacteria, on the skin of patients with Atopic Dermatitis (AD), after a single application.
Detailed description
This study will enroll a minimum of 20 participants, 18-80 years of age, with moderate-to-severe atopic dermatitis (AD) on their ventral arms. A minimum of 13 participants will have a positive Staphylococcus aureus (S. aureus) colonized lesion on both upper extremities. A minimum of 7 participants will have a negative S. aureus colonized lesion on both upper extremities.
The participant's colonization status will be determined from cultures taken during a pre-treatment phase, approximately 7 days prior to receiving study treatment on Day 0. On Day 0, skin swabs will be collected from lesional and non-lesional sites (at least 21cm^2) on the participant's right and left ventral arms and one non-lesional site on the participant's face. After the skin swab collections, the participant will have ShA9 applied to their right or left ventral arm and placebo applied to their contralateral ventral arm. The assignment of ShA9 and placebo to the dominant and non-dominant arms will be randomized. Additional swabs will be collected 15 minutes, and 1, 2, 4, and 6 hours after the ShA9 and placebo applications on Day 0.
Participants will be asked to return to the clinic 24 hours after receiving their single application and again on Days 3, 10, 17, and 24 for the assessment of adverse events (AEs) and the collection of skin swabs from the identified lesional and non-lesional sites, as needed. After the Day 3 visit, a participant will not be required to complete the Day 10, 17, and 24 visits if their lesional swabs are negative for Coagulase Negative Staphylococcal Species (CoNS).
All randomized participants will complete a final End of Study Phone visit on Day 31 to assess for adverse events and status of their AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShA9 | Experimental | Biological: S. hominis A 9 Product, Drug: PlaceboAll participants will receive ShA9 active treatment on one of their ventral arms and placebo on their contralateral arm. The assignment of ShA9 and placebo to the dominant and non-dominant arms will be randomized. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be able to understand and provide informed consent
- Meet Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria for active atopic dermatitis (AD)
- At least 21 cm^2 of lesional and 21 cm^2 of non-lesional skin on both the right and left ventral arms. The required area (lesional or non-lesional) may be one contiguous area or may encompass multiple areas with a total cumulative area of 21 cm^2
- An Investigator Global Assessment (IGA) score, on the ventral arms of at least moderate severity
- Body surface area (BSA), as measured by Mostellar BSA Calculator, between 1.26 m^2 and 2.25 m^2
Key exclusion criteria (21 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Pregnant or lactating females
- Active bacterial, viral, or fungal skin infections
- Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Cetaphil® Lotion, alcohol-based cleaners, glycerol, or soy products
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 |
|---|---|---|
| S. hominis A 9 ProductAlso: ShA9Commensal staph species, phosphate buffered saline, and glycerol. | Biological | ShA9 |
| PlaceboAlso: Placebo for S. hominis A 9 ProductPhosphate buffered saline and glycerol | Drug | ShA9 |
Primary outcome
The Duration of ShA9 Survival on the Lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).
Time frame: Day 0 to Day 24
Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). The primary endpoint was assessed based on samples from lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.
3 secondary outcomes
The Duration of ShA9 Survival on the Non-lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).
Time frame: Day 0 to Day 24
The Count of Serious Treatment-emergent Adverse Events Per Participant.
Time frame: Day 0 to Day 31
The Count of Non-serious Treatment-emergent Adverse Events Per Participant.
Time frame: Day 0 to Day 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
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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.
Richard Gallo, M.D., Ph.D. study chair
University of California, San Diego: Dermatology Clinical Trials Unit
Tissa Hata, M.D. study chair
University of California, San Diego: Dermatology Clinical Trials Unit
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 S. hominis A 9 Product in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 12 Nov 2024. 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. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Duration of ShA9 Survival on the Lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+). (time frame: Day 0 to Day 24). 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 12 Nov 2024.