Atopic DermatitisSTADENCT04715087
Staphylococcus Aureus in Atopic Dermatitis Immunopathology
A study testing Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13) and Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13) in people with Atopic Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Atopic Dermatitis (AD) is a frequent inflammatory skin disease characterized by recurrent eczema. It associates genetic/epigenetic-induced alterations of epidermal barrier and type-2 inflammation/hypersensitivity, which may be triggered by different antigens that pass through the altered skin . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13) and Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2022to 31 Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject over 18 years of age
- Subject able to read, understand and give documented informed consent
- Subject who gave written informed consent
- Subject willing and able to comply with the protocol requirements for the duration of the study
- Subjects with health insurance coverage according to local regulations
- For woman with childbearing potential;
Show all 16Show fewer
- Use of a highly effective method of birth control from at least 1 month prior to study enrollment until the last visit
- Negative urine pregnancy test at inclusion visit
- Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)
- Subject accepting patch-tests and skin biopsies Specific criteria for AD patients
- Subject diagnosed with moderate-to-severe AD, defined as EASI ≥7 and DLQI ≥ 6
- Subject with AD involvement of ≥ 5% of Body Surface Area (BSA)
- Subject with at least one AD lesion:
- Located either on upper extremities (except hands) or lower extremities (except feet)
- With a sufficient extent to allow all the investigations
- With a lesional area score ≥ 6
Who cannot join
- Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed during the study
- History of allergic reaction to local anesthetic product
- History of wound healing disorders (e.g. hypertrophic scars, keloids)
- Subject with known active infection to HBV, HCV or HIV
- Subject with known blood dyscrasia
- Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, corticoids, antihistamines, antibiotics or disinfectants on investigational limbs within 1 week before the inclusion visit
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- Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine, mycophenolate-mofetil, and/or any other systemic immunosuppressor/immunomodulator within 4 weeks before the study
- Subject treated by a biologic therapy within 3 months before the study
- Subject treated with ultraviolet therapy within 4 weeks before study
- Subject presenting clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact patient's ability to participate in the study or to impact the study efficacy or safety assessments
- Subject treated with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Subject with immunocompromised people in its close circle
- Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated)
- Subject in an exclusion period from a previous study or who is participating in another clinical trial
- Specific criteria for AD patients :
- o Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD
- Specific criteria for healthy control :
- Subject currently experiencing or having an history of AD or other concomitant condition that would interfere with evaluation of skin reaction induced by patch test
Trial locations and contacts
1 site in 1 country.
About this study
Atopic Dermatitis (AD) is a frequent inflammatory skin disease characterized by recurrent eczema. It associates genetic/epigenetic-induced alterations of epidermal barrier and type-2 inflammation/hypersensitivity, which may be triggered by different antigens that pass through the altered skin . Some studies have reported that environmental pathogens such as house dust mites are able to induce type-2 inflammation through particular activation of innate immunity .
Multiple staphylococcal strains are commonly found on the skin of AD patients. Interestingly, recent findings suggest that S. aureus may be a key factor of AD inflammation: (i) 90% of AD patients have S. aureus skin colonization on lesional skin , (ii) AD patients with S. aureus skin colonization have more increased type-2 inflammatory markers in comparison with AD patients without SA skin colonization , (iii) skin colonization by monoclonal S. aureus strains correlate with severe flares and (iv) S. aureus is detected in both epidermis and dermis during AD flares; In this study, our hypothesis is that S. aureus induces AD flares through a type 2 T cell-mediated hypersensitivity against S. aureus, involving innate and adaptive responses. Conversely, S. epidermidis, a commensal strain, has a protective effect against S. aureus dysbiosis. To this end, we will characterize, in the skin and the blood, the immune response induced by cutaneous application of : i) S. aureus isolated from patients with moderate-to-severe AD which will mimic the cutaneous dysbiosis occurring in the natural course of AD; ii) S. aureus toxins without bacteria to evaluate the skin response against those particular proteins; iii) a laboratory strain of S. epidermidis, a common well-tolerated skin commensal bacteria; iv) a mix of S. aureus and S. epidermidis to evaluate the regulatory effect of S. epidermidis on the S. aureus-induced AD inflammation.
Importantly, this characterization will be led in AD patients (with alterations of skin barrier), compared to healthy volunteers (without alterations of skin barrier), as controls.
- Conditions
- Atopic Dermatitis
- Being tested
- Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13), Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)
- Keywords
- Atopic dermatitis, Staphyloccocus aureus, Immunopathology
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13)Other
A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at screening and Day 3. Bacteriological samples from AD patients will be performed by swabbing the skin at screening visit (Day -42 to Day -28). Each sample will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be re-applied (via patchtest) to AD patient. A well-characterized S. epidermidis lab strain will be also applied to AD patients. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healed or improved area as defined by a lesional score ≤ 1 or a 2-point change from the baseline lesional score. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application.
Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)Other
A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at Day 0 and Day 3.
Each bacteriological sample from AD patients performed by swabbing the skin at screening visit will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be applied (via patchtest) to a paired (age/sex) healthy volunteer. A well-characterized S. epidermidis lab strain will be also applied to healthy volunteers. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healthy skin. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis patients | Other | Bacteriological skin swab samples from AD patients will be performed at screening visit. Each sample will be cultured and isolated to be re-applied (via patchtest) to AD patient. After reading the patch test results, skin biopsies will be performed Receives: Other: Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13) |
| Healthy controls | Other | Bacteriological skin swab samples from AD patients will be performed at screening visit. Each sample will be cultured and isolated to be applied (via patchtest) to a paired (age/sex) healthy volunteer. After reading the patch test results, skin biopsies will be performed. Receives: Other: Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a clinical inflammatory skin lesion after application of patch test containing a solution of methi-sensible (methi-S) S.aureus, in AD patients or healthy volunteers.
A difference of the local AD severity will be searched between baseline and after S. aureus patch test application (in AD patients and healthy volunteers) according to the lesional scoring and the patch test scoring. A logistic mixed effects model will be performed to model the occurrence of clinical inflammatory skin lesion. For each sub-population (AD patients or healthy volunteers), a linear mixed effect model will be used to model the lesional scoring.
Measured: Day 3
Secondary outcomes (5)
Molecular analysis of cytokine skin expression induced by S.aureus patch test.
Results will be expressed as fold change compared to control skin from the same individual (qPCR analysis).
- Type 2 inflammation: interleukins (IL)-4, 5, 13, 31
- Type 1 inflammation: TNF, IFNγ
- Type 17-22 inflammation: IL-12, IL-23, IL-17a, IL-22
- Innate inflammation: TSLP, IL-25, IL-33, IL-1b, IL-1a, IL-18
Then, a significant difference of each parameter cited above will also be searched between baseline and after S. aureus patch test application (in AD patients and healthy volunteers).
Measured: Day 3
Type 2 specific cellular and molecular regulatory and inflammatory response in blood - OPTIONAL (only in case of additional funding/grant)
A significant difference of parameters will be searched between baseline and after S. aureus patch test application (in AD patients and healthy volunteers)
Measured: Day 3
Presence/identification of S. aureus-specific virulence factors inducing a sensitization (immunoblotting) - OPTIONAL (only in case of additional funding/grant)
A significant difference of parameters will be searched between baseline and after S. aureus patch test application (in AD patients and healthy volunteers).
Measured: Day 3
Differences in clinical skin response against S. epidermidis and mix S. aureus/S. epidermidis.
Results will be expressed as fold change compared to control skin from the same individual (qPCR analysis).
- Type 2 inflammation: interleukins (IL)-4, 5, 13, 31)
- Type 1 inflammation: TNF, IFNγ
- Type 17-22 inflammation: IL-12, IL-23, IL-17a, IL-22
- Innate inflammation: TSLP, IL-25, IL-33, IL-1b, IL-1a, IL-18
Then, a significant difference of each parameter cited above will also be searched between S. epidermidis alone, mix S. epidermidis/S. aureus and S. aureus alone patch tests.
Measured: Day 3
Molecular analysis of cytokine skin expression induced by S. epidermidis and mix S. aureus/S. epidermidis.
Results will be expressed as fold change compared to control skin from the same individual (qPCR analysis).
- Type 2 inflammation: interleukins (IL)-4, 5, 13, 31)
- Type 1 inflammation: TNF, IFNγ
- Type 17-22 inflammation: IL-12, IL-23, IL-17a, IL-22
- Innate inflammation: TSLP, IL-25, IL-33, IL-1b, IL-1a, IL-18
Then, a significant difference of each parameter cited above will also be searched between S. epidermidis alone, mix S. epidermidis/S. aureus and S. aureus alone patch tests. A linear mixed effects model will be used to model each parameter of the molecular analysis of cytokine skin expression.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start26 Oct 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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 Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey NOSBAUM, MD, PhD, Principal investigator, Allergy and Clinical Immunology Department - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715087
- Sponsor's protocol ID
- 69HCL18_0732
- Other IDs
- 2020-A01547-32
- Acronym
- STADE
- Status last verified
- Sep 2025
- First submitted
- 14 Jan 2021
- Last updated
- 11 Sep 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus in Atopic Dermatitis Immunopathology
- ClinicalTrials.gov ID
- NCT04715087
- Acronym / sponsor ID
- STADE / 69HCL18_0732
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Staphyloccocus aureus, Immunopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 20 Jan 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.
Atopic Dermatitis (AD) is a frequent inflammatory skin disease characterized by recurrent eczema. It associates genetic/epigenetic-induced alterations of epidermal barrier and type-2 inflammation/hypersensitivity, which may be triggered by different antigens that pass through the altered skin . Some studies have reported that environmental pathogens such as house dust mites are able to induce type-2 inflammation through particular activation of innate immunity .
Multiple staphylococcal strains are commonly found on the skin of AD patients. Interestingly, recent findings suggest that S. aureus may be a key factor of AD inflammation: (i) 90% of AD patients have S. aureus skin colonization on lesional skin , (ii) AD patients with S. aureus skin colonization have more increased type-2 inflammatory markers in comparison with AD patients without SA skin colonization , (iii) skin colonization by monoclonal S. aureus strains correlate with severe flares and (iv) S. aureus is detected in both epidermis and dermis during AD flares; In this study, our hypothesis is that S. aureus induces AD flares through a type 2 T cell-mediated hypersensitivity against S. aureus, involving innate and adaptive responses. Conversely, S. epidermidis, a commensal strain, has a protective effect against S. aureus dysbiosis. To this end, we will characterize, in the skin and the blood, the immune response induced by cutaneous application of : i) S. aureus isolated from patients with moderate-to-severe AD which will mimic the cutaneous dysbiosis occurring in the natural course of AD; ii) S. aureus toxins without bacteria to evaluate the skin response against those particular proteins; iii) a laboratory strain of S. epidermidis, a common well-tolerated skin commensal bacteria; iv) a mix of S. aureus and S. epidermidis to evaluate the regulatory effect of S. epidermidis on the S. aureus-induced AD inflammation.
Importantly, this characterization will be led in AD patients (with alterations of skin barrier), compared to healthy volunteers (without alterations of skin barrier), as controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis patients | Other | Other: Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13)Bacteriological skin swab samples from AD patients will be performed at screening visit. Each sample will be cultured and isolated to be re-applied (via patchtest) to AD patient. After reading the patch test results, skin biopsies will be performed |
| Healthy controls | Other | Other: Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)Bacteriological skin swab samples from AD patients will be performed at screening visit. Each sample will be cultured and isolated to be applied (via patchtest) to a paired (age/sex) healthy volunteer. After reading the patch test results, skin biopsies will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject over 18 years of age
- Subject able to read, understand and give documented informed consent
- Subject who gave written informed consent
- Subject willing and able to comply with the protocol requirements for the duration of the study
- Subjects with health insurance coverage according to local regulations
Key exclusion criteria (18 listed)
- Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed during the study
- History of allergic reaction to local anesthetic product
- History of wound healing disorders (e.g. hypertrophic scars, keloids)
- Subject with known active infection to HBV, HCV or HIV
- Subject with known blood dyscrasia
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 |
|---|---|---|
| Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13)A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at screening and Day 3. Bacteriological samples from AD patients will be performed by swabbing the skin at screening visit (Day -42 to Day -28). Each sample will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be re-applied (via patchtest) to AD patient. A well-characterized S. epidermidis lab strain will be also applied to AD patients. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healed or improved area as defined by a lesional score ≤ 1 or a 2-point change from the baseline lesional score. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application. | Other | Atopic dermatitis patients |
| Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at Day 0 and Day 3. Each bacteriological sample from AD patients performed by swabbing the skin at screening visit will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be applied (via patchtest) to a paired (age/sex) healthy volunteer. A well-characterized S. epidermidis lab strain will be also applied to healthy volunteers. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healthy skin. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application | Other | Healthy controls |
Primary outcome
Occurrence of a clinical inflammatory skin lesion after application of patch test containing a solution of methi-sensible (methi-S) S.aureus, in AD patients or healthy volunteers.
Time frame: Day 3
A difference of the local AD severity will be searched between baseline and after S. aureus patch test application (in AD patients and healthy volunteers) according to the lesional scoring and the patch test scoring. A logistic mixed effects model will be performed to model the occurrence of clinical inflammatory skin lesion. For each sub-population (AD patients or healthy volunteers), a linear mixed effect model will be used to model the lesional scoring.
5 secondary outcomes
Molecular analysis of cytokine skin expression induced by S.aureus patch test.
Time frame: Day 3
Type 2 specific cellular and molecular regulatory and inflammatory response in blood - OPTIONAL (only in case of additional funding/grant)
Time frame: Day 3
Presence/identification of S. aureus-specific virulence factors inducing a sensitization (immunoblotting) - OPTIONAL (only in case of additional funding/grant)
Time frame: Day 3
Differences in clinical skin response against S. epidermidis and mix S. aureus/S. epidermidis.
Time frame: Day 3
Molecular analysis of cytokine skin expression induced by S. epidermidis and mix S. aureus/S. epidermidis.
Time frame: Day 3
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 11 Sep 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.
Audrey NOSBAUM, MD, PhD principal investigator
Allergy and Clinical Immunology Department - Centre Hospitalier Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13) and Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13) in people with Atopic Dermatitis, run by Hospices Civils de Lyon at 1 site in France.
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 18 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 11 Sep 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 France. 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.
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?
Occurrence of a clinical inflammatory skin lesion after application of patch test containing a solution of methi-sensible (methi-S) S.aureus, in AD patients or healthy volunteers. (time frame: Day 3). 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 11 Sep 2025.