Systemic SclerosisOCTISSNCT04532151
Optical Coherence Tomography Imaging in Systemic Sclerosis
A study testing Non-invasive skin imaging assessment in people with Systemic Sclerosis and Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years
- What is being tested?
- Non-invasive skin imaging assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1 "Early SSc group": Patients with SSc according to ACR / EULAR criteria (2013) early onset <2 years and without clinical cutaneous sclerosis
- Group 2 "Established SSc group": Patients with SSc according to ACR / EULAR criteria (2013) with cutaneous sclerosis
- Group 3 "Control group": Hospitalized patients in the Rheumatology Department of the University Hospitals of Strasbourg, excluding connective tissue disease
Who cannot join
- Non-inclusion criteria for patients / controls in 3 groups
- Subject having undergone a physical treatment (radiotherapy, surgical intervention ...) on the cutaneous sites studied
- Subjects who received general corticosteroid therapy in the last 3 months
- Subjects being treated with topical corticosteroids on the different cutaneous sites studied
- Impossibility to give clear information of subject (subject in emergency situation, subject with difficulties of understanding ...)
- Subject in exclusion period (determined by previous or current study),
Show all 16Show fewer
- Subject under the protection of justice, guardianship or curatorship
- Pregnancy (on declaration of the patient)
- Non-inclusion criteria specific to each group
- Group 1 "Early SSc group": Patients with SSc and having a clinical cutaneous sclerosis
- Group 2 "Established SSc group": Patients with criteria for another systemic autoimmune disease
- Group 3 "Control group":
- Subjects with scleroderma,
- Subjects with Raynaud's phenomenon
- Subjects with other sclerosing disease (morphea, Shulman,…)
- Diabetic subjects
Trial locations and contacts
1 site in 1 country.
About this study
Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis.
Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis.
The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.
Read the detailed description
Systemic sclerosis (SSc) is a rare autoimmune disorder. It is characterized by fibrosis and vascular obliteration in the skin and other organs. Skin damage, manifested by thickening of the skin tissue, is often one of the first signs of the disease. Pathogenesis is dominated by early microvascular changes targeting endothelial cells and with the release of several mediators promoting an inflammatory response and vascular remodeling. This inflammatory cascade results in fibrosis lesions. Early diagnosis of fibrosing skin lesions is essential in SSc since their severity is correlated with functional prognosis and survival. To date, there is no validated tool to reliably quantify skin fibrosis. The semi-quantitative Modified Rodnan score (mRSS), based on clinical assessment of skin thickening at 17 anatomical areas, is widely used. The main limitation of this method is its inter-operator variability. The histopathological analysis of the skin biopsy is interesting but invasive. The new non-invasive and reproducible tools are needed to evaluate skin fibrosis for early diagnosis of SSc.
Optical coherence tomography (OCT) is an innovative imaging technique that uses a light wave to capture 3D images of a material that scatters light. OCT allows real-time, direct and high-resolution imaging of the morphology of the biological sample (such as skin) without ionizing radiation. In SSc, the cutaneous fibrosis is characterized by a deregulated production of the components of the extracellular matrix, in particular collagen. Previous results showed that the dermal-epidermal junction could be observed in healthy subjects using OCT. In patients with SSc and skin involvement, the visualization of this junction could be reduced. The results suggest a possible correlation between the intensity of visualization of the dermo-epidermal junction and the severity of cutaneous fibrosis.
In this project, we would like to compare the skin involvement of the dorsal surface of a finger between patients with early SSc and control subjects using non-invasive OCT imaging. The study population meets the criteria for early SCS, with onset of disease less than 2 years and without clinically detectable skin involvement. In a second time, other imaging techniques (HD ultrasound) or fluid silicone molding technique will be used to evaluate the progression of skin fibrosis or the morphological characteristics of the skin or vascular network of the patient with early SSc. To complete the work, these parameters will be evaluated in other anatomical sites (outer and inner side of the forearm) or in another group of patients (Established SSc patients with clinical cutaneous sclerosis) or at another timepoint (M24). The hypothesis of this study is that OCT can be used to identify SSc patients at a stage where the lesions are still early and reversible.
This is a prospective, monocentric, comparative, open-label and longitudinal patient study with duration of 36 months. The duration of the inclusion period will be 12 months. The participation of each subject is from 1 hour (for group 2 and 3) to 24 months (for group 1). We planned to include 60 patients in the Department of Rheumatology of the University Hospital of Strasbourg (20 patients from each group).
The different measures in the study are not invasive. No specific biological sampling of the study will be conducted. There will be no change for the treatment of patients either.
- Conditions
- Systemic Sclerosis, Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years
- Being tested
- Non-invasive skin imaging assessment
- Keywords
- Systemic sclerosis, Scleroderma, Optical coherence tomography (OCT)
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive skin imaging assessmentDiagnostic test
Intervention Description : (Limit: 1000 characters) Do not repeat information already included in arm/group descriptions. Specify details not covered in associated Arm
One session of Non-invasive skin imaging assessment contained:
- an examination on LC-OCT
- an examination on LC-OCT-doppler
- a fluid silicone molding
- an examination on HD ultrasound
The measurements will be applied on 3 skin sites: the dorsal surface of the finger, the inner face and the outer surface of the forearm.
The imaging assessment lasts 30 minutes in a dimly lit room where the humidity and temperature are stable.
| Study group | Role | What they receive |
|---|---|---|
| Early SSc group | Other | Patients with SSc according to the criteria ACR / EULAR 2013, without scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements.
Patients will be reassessed at M24. The participation of each subject will be 24 months, with two visits of one hour.
The clinical data corresponding to the current practice will be collected in a study specific case report form. Receives: Diagnostic Test: Non-invasive skin imaging assessment |
| Established SSc group | Other | Patients with SSc according to criteria ACR / EULAR 2013 with scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements. The participation of each subject will be one hour.
The clinical data corresponding to the current practice will be collected in a study specific case report form. Receives: Diagnostic Test: Non-invasive skin imaging assessment |
| Control group: | Other | Patient without systemic sclerosis Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The participation of each subject will be one hour.
The clinical data corresponding to the current practice will be collected in a study specific case report form. Receives: Diagnostic Test: Non-invasive skin imaging assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic density of the papillo-reticular dermis on the dorsal surface of a finger
The optic density of the papillo-reticular dermis, 300 μm deep, on the dorsal surface of a finger will be measured in all three groups using optical coherence tomography (OCT)
Measured: This parameter will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0)
Optic density of the papillo-reticular dermis on the dorsal surface of a finger
Measured: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
Secondary outcomes (8)
Optic density of the papillo-reticular dermis at the outer and inner side of the forearm
The optic density of the papillo-reticular dermis, 300 μm deep, at the outer and inner side of the forearm will be measured in all three patient groups using OCT.
Measured: These parameters will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0).
Optic density of the papillo-reticular dermis at the outer and inner side of the forearm
The optic density of the papillo-reticular dermis, 300 μm deep, at the outer and inner side of the forearm will be measured in all three patient groups using OCT.
Measured: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
Modified Rodnan skin score (mRSS)
The Modified Rodnan Score (mRSS) will be evaluated by an experienced clinician at each anatomical site studied during a hospital consultation. The test lasts 5 minutes. The evaluator will be blinded from the results of the imaging.
Measured: The assessment will be applied only to patients in group 1 (Early SSc group) and group 2 (Established SSc group) at the inclusion visit (V0).
Modified Rodnan skin score (mRSS)
Measured: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
The thickness of the hypodermis, obtained by HD ultrasound.
Measured: Day 0
The thickness of the dermis, obtained by HD ultrasound
Measured: Day 0
The distribution of tension forces exerted within the dermis by fluid silicone molding techniques
Measured: Day 0
The optic density of the papillo-reticular dermis, 300 μm deep, at the outer and inner side of the forearm will be measured in all three patient groups using OCT.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start2 Feb 2021
- Primary completion26 May 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Chatelus, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532151
- Sponsor's protocol ID
- 7630
- Acronym
- OCTISS
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Imaging in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04532151
- Acronym / sponsor ID
- OCTISS / 7630
- Conditions
- Systemic Sclerosis, Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years
- Keywords
- Systemic sclerosis, Scleroderma, Optical coherence tomography (OCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 31 Aug 2020 (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.
Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis.
Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis.
The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.
Detailed description
Systemic sclerosis (SSc) is a rare autoimmune disorder. It is characterized by fibrosis and vascular obliteration in the skin and other organs. Skin damage, manifested by thickening of the skin tissue, is often one of the first signs of the disease. Pathogenesis is dominated by early microvascular changes targeting endothelial cells and with the release of several mediators promoting an inflammatory response and vascular remodeling. This inflammatory cascade results in fibrosis lesions. Early diagnosis of fibrosing skin lesions is essential in SSc since their severity is correlated with functional prognosis and survival. To date, there is no validated tool to reliably quantify skin fibrosis. The semi-quantitative Modified Rodnan score (mRSS), based on clinical assessment of skin thickening at 17 anatomical areas, is widely used. The main limitation of this method is its inter-operator variability. The histopathological analysis of the skin biopsy is interesting but invasive. The new non-invasive and reproducible tools are needed to evaluate skin fibrosis for early diagnosis of SSc.
Optical coherence tomography (OCT) is an innovative imaging technique that uses a light wave to capture 3D images of a material that scatters light. OCT allows real-time, direct and high-resolution imaging of the morphology of the biological sample (such as skin) without ionizing radiation. In SSc, the cutaneous fibrosis is characterized by a deregulated production of the components of the extracellular matrix, in particular collagen. Previous results showed that the dermal-epidermal junction could be observed in healthy subjects using OCT. In patients with SSc and skin involvement, the visualization of this junction could be reduced. The results suggest a possible correlation between the intensity of visualization of the dermo-epidermal junction and the severity of cutaneous fibrosis.
In this project, we would like to compare the skin involvement of the dorsal surface of a finger between patients with early SSc and control subjects using non-invasive OCT imaging. The study population meets the criteria for early SCS, with onset of disease less than 2 years and without clinically detectable skin involvement. In a second time, other imaging techniques (HD ultrasound) or fluid silicone molding technique will be used to evaluate the progression of skin fibrosis or the morphological characteristics of the skin or vascular network of the patient with early SSc. To complete the work, these parameters will be evaluated in other anatomical sites (outer and inner side of the forearm) or in another group of patients (Established SSc patients with clinical cutaneous sclerosis) or at another timepoint (M24). The hypothesis of this study is that OCT can be used to identify SSc patients at a stage where the lesions are still early and reversible.
This is a prospective, monocentric, comparative, open-label and longitudinal patient study with duration of 36 months. The duration of the inclusion period will be 12 months. The participation of each subject is from 1 hour (for group 2 and 3) to 24 months (for group 1). We planned to include 60 patients in the Department of Rheumatology of the University Hospital of Strasbourg (20 patients from each group).
The different measures in the study are not invasive. No specific biological sampling of the study will be conducted. There will be no change for the treatment of patients either.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early SSc group | Other | Diagnostic Test: Non-invasive skin imaging assessmentPatients with SSc according to the criteria ACR / EULAR 2013, without scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements. Patients will be reassessed at M24. The participation of each subject will be 24 months, with two visits of one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form. |
| Established SSc group | Other | Diagnostic Test: Non-invasive skin imaging assessmentPatients with SSc according to criteria ACR / EULAR 2013 with scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements. The participation of each subject will be one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form. |
| Control group: | Other | Diagnostic Test: Non-invasive skin imaging assessmentPatient without systemic sclerosis Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The participation of each subject will be one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Group 1 "Early SSc group": Patients with SSc according to ACR / EULAR criteria (2013) early onset <2 years and without clinical cutaneous sclerosis
- Group 2 "Established SSc group": Patients with SSc according to ACR / EULAR criteria (2013) with cutaneous sclerosis
- Group 3 "Control group": Hospitalized patients in the Rheumatology Department of the University Hospitals of Strasbourg, excluding connective tissue disease
Key exclusion criteria (16 listed)
- Non-inclusion criteria for patients / controls in 3 groups
- Subject having undergone a physical treatment (radiotherapy, surgical intervention ...) on the cutaneous sites studied
- Subjects who received general corticosteroid therapy in the last 3 months
- Subjects being treated with topical corticosteroids on the different cutaneous sites studied
- Impossibility to give clear information of subject (subject in emergency situation, subject with difficulties of understanding ...)
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 |
|---|---|---|
| Non-invasive skin imaging assessmentIntervention Description : (Limit: 1000 characters) Do not repeat information already included in arm/group descriptions. Specify details not covered in associated Arm One session of Non-invasive skin imaging assessment contained: * an examination on LC-OCT * an examination on LC-OCT-doppler * a fluid silicone molding * an examination on HD ultrasound The measurements will be applied on 3 skin sites: the dorsal surface of the finger, the inner face and the outer surface of the forearm. The imaging assessment lasts 30 minutes in a dimly lit room where the humidity and temperature are stable. | Diagnostic test | Control group:, Early SSc group, Established SSc group |
Primary outcome
Optic density of the papillo-reticular dermis on the dorsal surface of a finger
Time frame: This parameter will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0)
The optic density of the papillo-reticular dermis, 300 μm deep, on the dorsal surface of a finger will be measured in all three groups using optical coherence tomography (OCT)
Optic density of the papillo-reticular dermis on the dorsal surface of a finger
Time frame: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
8 secondary outcomes
Optic density of the papillo-reticular dermis at the outer and inner side of the forearm
Time frame: These parameters will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0).
Optic density of the papillo-reticular dermis at the outer and inner side of the forearm
Time frame: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
Modified Rodnan skin score (mRSS)
Time frame: The assessment will be applied only to patients in group 1 (Early SSc group) and group 2 (Established SSc group) at the inclusion visit (V0).
Modified Rodnan skin score (mRSS)
Time frame: Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).
The thickness of the hypodermis, obtained by HD ultrasound.
Time frame: Day 0
The thickness of the dermis, obtained by HD ultrasound
Time frame: Day 0
The distribution of tension forces exerted within the dermis by fluid silicone molding techniques
Time frame: Day 0
The optic density of the papillo-reticular dermis, 300 μm deep, at the outer and inner side of the forearm will be measured in all three patient groups using OCT.
Time frame: Day 0
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 14 Aug 2023.
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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.
Emmanuel Chatelus, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive skin imaging assessment in people with Systemic Sclerosis and Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years, run by University Hospital, Strasbourg, France 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 3 inclusion and 16 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 14 Aug 2023. 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?
Optic density of the papillo-reticular dermis on the dorsal surface of a finger (time frame: This parameter will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.