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Atopic DermatitisPhase 1NCT06504160

Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)

A Phase 1 study testing ShA9 Topical Gel, Hydrocortisone Ointment and Clobetasol Ointment in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and pediatric participants with atopic dermatitis. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
ShA9 Topical Gel, Hydrocortisone Ointment and Clobetasol Ointment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
8 sitesUnited States
Study dates
22 May 2025to 5 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:
  • Participant and/or parent/legal guardian must be able to understand and provide informed consent and assent (if applicable).
  • Male or female participant 6 years of age or older.
  • Meet ADRN Standard Diagnostic Criteria for active AD.
  • Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:
  • Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.
Show all 16Show fewer
  • Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.
  • Have an IGA score of two or greater.
  • Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.
  • Willing to remain abstinent from intercourse that may result in a pregnancy.
  • Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:
  • Permanent sterilization of partner
  • Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.
  • Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline
  • Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)
  • Have obtained negative pregnancy test results during both the Screening and Baseline Visits.

Who cannot join

  • Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:
  • Inability or unwillingness to give written informed consent or comply with study protocol.
  • Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.
  • Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol, hydroxyethylcellulose or soy products.
  • Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
  • History of serious life-threatening reaction to tape or adhesives.
Show all 34Show fewer
  • Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin, mupirocin, nitrofurantoin, oxacillin, rifampin, trimethoprim-sulfamethoxazole, and vancomycin.
  • Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).
  • Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).
  • Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).
  • Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.
  • Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five 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 any biologic, including dupilumab, within 16 weeks of the Screening Visit.
  • Treatment with oral or injectable therapy for AD (excluding oral steroids) within five half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer.
  • Treatment with oral retinoids (e.g., isotretinoin) within 60 days of the Screening Visit.
  • Treatment with allergen immunotherapy within 30 days of Screening Visit.
  • Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.
  • May, in the opinion of the investigator, have difficulty tolerating the medication washout requirements for topical AD treatments, prescription moisturizers, antibiotics, oral steroid therapies, and phototherapy ahead of Baseline.
  • Past or current medical conditions 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.
  • Individuals who meet any of the following criteria at Baseline are not eligible for enrollment as study participants:
  • Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.
  • Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.
  • 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.
  • At the investigator's discretion, participants with minor breaks, cracks, or excoriations on body areas not eligible for sampling during the trial may be enrolled, provided there is no evidence of infection and investigational product is not applied to these areas until healed.
  • Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.
  • Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.
  • Use of any systemic microbialª within fourteen days of the Baseline Visit, or use of any topical antimicrobial on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within fourteen days of the Baseline Visit.
  • Antimicrobials include antibiotics, antifungals, antiparasitics, and antivirals. Certain systemic antivirals that do not exhibit systemic anti-inflammatory effects may be permitted with prior approval from a protocol co-chair).
  • Within the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), and trunk, use of topical products - prescription or over-the-counter, all formulations - not specified per protocol, within seven days of the Baseline Visit.
  • Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.
  • Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.
  • Require a dose greater than 880 mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control, at the time of the Baseline 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 Baseline Visit.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites, 7 recruiting

  • Northwestern University Feinberg School of Medicine: Department of Dermatology

    Chicago, Illinois, 60611

    Jennifer Zhang, jennifer.zhang1@northwestern.edu

    Amy Paller, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center: Asthma Center

    Cincinnati, Ohio, 45229

    Elsie Parmar, 513-517-1233, elsie.parmar@cchmc.org

    Neeru Hershey, MD

    Recruiting

  • National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

    Denver, Colorado, 80206

    Tyler Swenson, 303-398-1409, swensont@njhealth.org

    Donald Leung, MD

    Recruiting

  • University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology

    Madison, Wisconsin, 53792

    Kenzie Keil, mkeil@medicine.wisc.edu

    Anne Marie Singh, MD

    Recruiting

  • New York University Langone Health: Department of Pediatric Allergy and Immunology

    New York, New York, 10016

    Terminated

  • Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

    New York, New York, 10029

    Rachel Karalekas, 212-241-3288, rachel.karalekas@mssm.edu

    Emma Guttman, MD

    Recruiting

  • University of Rochester Medical Center: Department of Dermatology

    Rochester, New York, 10029

    Kimberly Arnold, 585-273-4195, kimberly_arnold@urmc.rochester

    Lisa Beck, MD

    Recruiting

  • University of California, San Diego: Dermatology Clinical Trials Unit

    San Diego, California, 92093

    Alexandra Fernandez-Desoto, 858-657-8390, alf013@health.ucsd.edu

    Tissa Hata, MD

    Recruiting

Other trials in United States

About this study

Official title: Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9

This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and pediatric participants with atopic dermatitis.

The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

Read the detailed description

Protocol ADRN-14 TIME-2 is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial designed to assess the safety and efficacy of ShA9 topical application as a treatment for AD. This study will aim to enroll approximately 86 participants; participants must be 6 years of age or older and have AD.

An individual participant's involvement in this study will take approximately 20 weeks to complete, including approximately 2 weeks of screening, 14 weeks of treatment, and 4 weeks of safety follow-up.

An initial screening visit will be conducted to evaluate eligibility and to assess skin swabs collected from each participant for the presence of S. Aureus. Eligible participants will then begin an approximately 14-day period of standardized skin care by using over-the-counter products (e.g., Dove soap, Cetaphil moisturizer) which will be distributed from the study clinic. This is done to establish an informative baseline and allow for washout of any prohibited medications.

Participants who continue to meet eligibility criteria will then be randomized 1:1 to use either ShA9 gel or placebo (vehicle) gel for treatment of AD. Following randomization, for two weeks, each participant will receive co-treatment using TCS together with their assigned study product (active or placebo). Participants will then continue using their assigned study product without TCS for 12 more weeks. Participants will be seen in clinic approximately every 4 weeks during this time for sample/data collection and safety monitoring. Participants may be seen in clinic for additional visits to address any skin exacerbations while enrolled.

Participation concludes with a 4-week safety follow-up period during which use of ShA9 or placebo (vehicle) gel is halted. Participants will continue using over-the-counter products provided by the study clinic, as needed, while avoiding prohibited medications, and will be monitored for skin exacerbations and other adverse events.

Being tested
ShA9 Topical Gel, Hydrocortisone Ointment, Clobetasol Ointment, Fluocinonide Ointment, Placebo (Vehicle) Topical Gel
Keywords
atopic dermatitis, eczema, ADRN, TIME-2, microbiome, Staphylococcus hominis
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.

  • ShA9 Topical GelDrug

    The ShA9 topical gel contains phosphate-buffered saline solution (PBS), Glycerol, and hydroxyethylcellulose containing lyophilized ShA9 bacteria. The ShA9 bacteria is derived from a healthy donor-derived (allogeneic) commensal Staph species. The gel is manufactured and packaged by University of California San Diego (UCSD). It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 14 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 14 Visit.

  • Hydrocortisone OintmentDrug

    Participants of all ages will apply hydrocortisone ointment 2.5% alongside the study product in sensitive body areas (e.g., face, neck, intertriginous regions) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.

  • Clobetasol OintmentDrug

    Participants 12 years of age and older will apply clobetasol ointment 0.05% alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It will be applied twice daily to lesional skin and selected sampling areas from Baseline to Week 2. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.

  • Fluocinonide OintmentDrug

    Participants 12 years of age and older with a past intolerance to clobetasol or who become too sensitive to clobetasol in the initial two-week cotreatment period will apply fluocinonide ointment 0.05% as an alternative. In these cases, fluocinonide ointment 0.05% will be applied alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.

  • Placebo (Vehicle) Topical GelDrug

    The placebo (vehicle) topical gel contains phosphate-buffered saline solution (PBS), Glycerol, and hydroxyethylcellulose. The gel is manufactured and packaged by University of California San Diego (UCSD). It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 14 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 14 Visit.

  • Triamcinolone OintmentDrug

    Participants 6 to 11 years of age will apply triamcinolone ointment 0.025% alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.

Study groups in NCT06504160
Study groupRoleWhat they receive
ShA9 Topical GelExperimentalFrom baseline to Week 2, ShA9 and TCS will be applied twice daily to selected and new lesions; once treated, areas will continue treatment regardless of lesion status. Age 6-11: Triamcinolone will be applied before ShA9 in non-sensitive areas; hydrocortisone will be applied with ShA9 in sensitive areas. Age ≥12: Clobetasol (or fluocinonide, for participants intolerant to clobetasol) will be applied before ShA9 in non-sensitive areas; hydrocortisone will be applied with ShA9 in sensitive areas. After 2 weeks, all participants will continue applying ShA9 without TCS for 12 additional weeks, applying ShA9 to all previously treated and new lesions through Week 14 regardless of lesion status.
Receives: Drug: ShA9 Topical Gel; Drug: Hydrocortisone Ointment; Drug: Clobetasol Ointment; Drug: Fluocinonide Ointment; Drug: Triamcinolone Ointment
Placebo (Vehicle) Topical GelPlacebo comparatorFrom baseline to Week 2, placebo (vehicle) and TCS will be applied twice daily to selected and new lesions; once treated, areas will continue treatment regardless of lesion status. Age 6-11: Triamcinolone will be applied before placebo (vehicle) in non-sensitive areas; hydrocortisone will be applied with placebo (vehicle) in sensitive areas. Age ≥12: Clobetasol (or fluocinonide, if the participant is intolerant to clobetasol) will be applied before placebo (vehicle) in non-sensitive areas; hydrocortisone will be applied with placebo (vehicle) in sensitive areas. After 2 weeks, participants will continue placebo (vehicle) without TCS for 12 additional weeks, applying placebo (vehicle) to all previously treated and new lesions through Week 14 regardless of lesion status.
Receives: Drug: Hydrocortisone Ointment; Drug: Clobetasol Ointment; Drug: Fluocinonide Ointment; Drug: Placebo (Vehicle) Topical Gel; Drug: Triamcinolone Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the first Atopic Dermatitis (AD) flare.

    Time (in days) to the first Atopic Dermatitis (AD) flare, indicated by having an Investigator Global Assessment (IGA) score that is greater than or equal to 2 and greater than the IGA score determined at Week 2. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe).

    Measured: Week 2 (exclusive) through Week 14 (inclusive)

  2. Serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment.

    The number of serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs.

    Measured: Baseline through Week 14

Secondary outcomes (10)

  1. Serious and non-serious TEAEs related or possibly related to study treatment.

    The number of serious and non-serious TEAEs related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs.

    Measured: Week 14 (exclusive) through Week 18

  2. Antibiotic sensitivity of S. aureus and S. epidermidis on the skin.

    The proportion of the skin bacteria, S. aureus and S. epidermidis, which can be isolated from skin swabs, that are sensitive to each of the following antibiotics: penicillin G, tetracycline, and erythromycin at Week 14 (post-ShA9 treatment) adjusted for the proportion of bacteria sensitive to antibiotic at Baseline.

    Measured: Baseline, Week 14

  3. Change in total Eczema Area and Severity Index (EASI) score.

    The change in total Eczema Area and Severity Index (EASI) score, which measures physical signs of atopic dermatitis, including area of involvement and severity (range: 0-72). Severity components include erythema, papulation, excoriation, and lichenification (0=absent, 1=mild, 2=moderate, 3=severe) for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for a total EASI score (≤7=mild, >7 and ≤21.1=moderate, >21.1=severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  4. EASI 50

    The proportion of participants who achieve 50% or more reduction in their total EASI score. Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  5. EASI 75

    The proportion of participants who achieve 75% or more reduction in their total EASI score. Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  6. Change in IGA score

    The change in IGA score. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their IGA score at this timepoint will not be considered. Instead, the most recent IGA score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  7. Change in Pruritus Numeric Rating Scale (NRS) score.

    The change in Pruritus Numeric Rating Scale (NRS) score, which measures the average intensity of a pruritus (itch) during a 24-hour recall period on a scale of 0 (none) to 10 (worst imaginable itch). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their NRS score at this timepoint will not be considered. Instead, the most recent NRS score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  8. Change in SCORing Atopic Dermatitis (SCORAD) score.

    The change in SCORing Atopic Dermatitis (SCORAD) score, which ranges from 0 (no AD) to 103 (severe). SCORAD is a composite index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments of itch and sleep loss, each on a scale of 0 (none) to 10 (worst imaginable), and c) 6 disease intensity assessments: dryness, erythema, edema/papulation, excoriation, lichenification and oozing/crusting, each graded from 0 (none) to 3 (severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their SCORAD score at this timepoint will not be considered. Instead, the most recent SCORAD score before the use of rescue TCS will be carried forward to represent Week 14.

    Measured: Baseline, Week 14

  9. Duration of rescue topical corticosteroid (TCS) use.

    The total number of days that topical corticosteroid (TCS) was used as a rescue medication within the upper extremities, lower extremities, and trunk of the body region, overall and separated by the potency class of steroids. The decision to begin the rescue TCS regimen due to skin exacerbation is dependent on investigator assessment, self-reported participant need, and standard of care.

    Measured: Week 2 (exclusive) through Week 14 (inclusive)

  10. Time to the first reported use of rescue TCS.

    Time (in days) to the first reported use of rescue TCS. The decision to begin the rescue TCS regimen due to skin exacerbation is dependent on investigator assessment, self-reported participant need, and standard of care.

    Measured: Week 2 (exclusive) through Week 14 (inclusive)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start22 May 2025
  3. Primary completion24 Dec 2026 (estimated)
  4. Study completion5 Feb 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504160
Sponsor's protocol ID
DAIT ADRN-14
Status last verified
Jul 2026
First submitted
10 Jul 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Share data upon study completion in Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ShA9 Topical Gel, Hydrocortisone Ointment and Clobetasol Ointment in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites 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 16 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the first Atopic Dermatitis (AD) flare. (time frame: Week 2 (exclusive) through Week 14 (inclusive)). 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?

On the ClinicalTrials.gov record for NCT06504160.

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 2 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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