Topical AnaesthesiaPhase 1NCT03629041
A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
A Phase 1 study testing Microneedle Patch and Patch with no microneedles in people with Topical Anaesthesia, run by Innoture Ltd at 1 site in United Kingdom.
Trial summary
To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Topical Anaesthesia
- What is being tested?
- Microneedle Patch and Patch with no microneedles
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2018to 22 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be aged 18 years and over, of either gender and in good health;
- be willing and physically able to carry out all study procedures;
- be willing and able to give Informed Consent and provide details of any medical history;
- be available for all of the study dates
- have a good standard of oral hygiene and gingival health
- must have 1 premolar or canine in each quadrant that has no/minimal restorations
Who cannot join
- presence of soft tissue oral pathology;
- presence of advanced periodontal disease;
- Individuals with any serious health conditions, that would preclude participation, in the professional judgement of the Study Dentist;
- individuals with known allergies or sensitivities to local anaesthetics
- have participated in another clinical trial in the last 30 days
- in the opinion of the investigator unable to comply fully with the trial requirements.
- the subject is an employee of the Sponsor or the site conducting the study
Trial locations and contacts
1 site in 1 country.
About this study
To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the safety of the patches when applied to the oral mucosa.
Read the detailed description
This is a randomised, 2 treatment, double blind design, with respect to the clinical assessor and subject, split mouth, crossover design with a negative control (patch with no microneedles).
Potential participants will be invited to attend a screening visit. At this visit participants will be asked to read and sign a Participant Information Sheet and Consent Form prior to any study procedures being performed. They will be given ample time to decide if they wish to participate in the study.
A dentally qualified clinician will record the participant's demographics, medical history, current/concomitant medications, perform an oral soft tissue examination and ensure the participant fulfils the inclusion and exclusion criteria for the study. Two areas of the mouth will be identified for assessment during the study. The areas of the mouth will be identified as S1 or S2. Site S1 will be left or right palatal mucosa adjacent to the premolar area and S2 will be left or right upper buccal mucosa adjacent to the upper lateral incisor area.
Participants who successfully fulfil all the necessary entrance criteria will be provided with training by study staff on how to use a VAS record sheet and randomised on to the study to receive treatment combination A or B at in a random order according to a predetermined randomisation schedule supplied by the study statistician. The screening visit and first treatment visit will occur at the same visit. The treatment possibilities are outlined below:
Treatment A The application of a 5% topical lidocaine gel to one of the identified areas within the participants mouth using a microneedle patch. The microneedle patch will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.
Treatment B The application of a 5% topical lidocaine gel to one of the identified sites within the participants mouth using a patch with no microneedles. The patch with no microneedles will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.
The chosen sites will be: S1; left and right palatal mucosa adjacent to the premolar area or S2; left and right upper buccal mucosa adjacent to the upper lateral incisor area. Each participant at the first visit will have either S1 or S2 sites allocated for treatment. For example, Treatment A will be allocated to S1 left side and Treatment B to S1 right side or vice versa. At the second visit, 2 weeks (+/- 3 days) after the first visit, Treatment B will be allocated to S2 left side and Treatment A to S2 right side. Both sides of the mouth for S1 or S2 will be treated at the same. After each treatment participants will be asked to make pain assessments relating to needle insertion into the oral mucosa and the giving of the local infiltration anaesthetic.
It is envisaged that a sufficient number of potential participants will be screened in order to randomise 16 onto the study.
Assessment methods: Pain assessments will be performed after application of the topical anaesthetic for 3 minutes. Each test will be performed sequentially i.e. 3 separate needle insertions, with pain assessments recorded by the participant using a Visual Analogue Scale (VAS) and a verbal pain grading after each test. The level of pain at S1 or S2 will be assessed as follows:
Test I. A short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, will be used to penetrate the oral mucosa at the treated site and the patient asked to score the pain using a VAS rating scale and by verbal grading of zero, mild, moderate or severe.
Test 2. The same needle will be inserted through the oral mucosa and down to contact bone. Pain will be assessed as in Test 1.
Test 3. The same needle will be again inserted through the oral mucosa and the cartridge of local anaesthetic will be injected into the site. Pain will be again assessed as in Test I.
Following enrolment on to the study, participants will be given written and verbal instructions on the VAS and how to complete it.
- Conditions
- Topical Anaesthesia
- Being tested
- Microneedle Patch, Patch with no microneedles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle PatchDevice
At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.
Patch with no microneedlesDevice
At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - Microneedle patch | Experimental | The application of a 5% topical lidocaine gel to one of the identified areas within the participants mouth using a microneedle patch. The microneedle patch will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth. Receives: Device: Microneedle Patch |
| Treatment B - Patch with no microneedles | Sham comparator | The application of a 5% topical lidocaine gel to one of the identified sites within the participants mouth using a patch with no microneedles. The patch with no microneedles will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth. Receives: Device: Patch with no microneedles |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.
Measured: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Pain levels will be recorded using a Verbal Pain Grading. For the verbal pain grading, subjects are asked to score either zero, mild, moderate or severe. In test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site.
Measured: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 2, the same needle as test 1 was inserted through the oral mucosa and down to contact bone.
Measured: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 3, the same needle as test 1 and test 2 was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.
Measured: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Secondary outcomes (1)
Adverse Events in Healthy Participants When a Proprietary Topical 5% Lidocaine Dental Gel Was Applied to the Oral Mucosa With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
Adverse events were recorded
Measured: Events were collected from the time of informed consent until end of treatment or when an ongoing AE had resolved whichever was latest, unless the PI & the Innoture contact from the clinical investigation plan agreed that no further follow up was needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start31 Jul 2018
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
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 Topical AnaesthesiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innoture Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola X West, Principal investigator, Bristol Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629041
- Sponsor's protocol ID
- Innoture/NW-01
- Status last verified
- Oct 2019
- First submitted
- 24 Jul 2018
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
- ClinicalTrials.gov ID
- NCT03629041
- Acronym / sponsor ID
- Innoture/NW-01
- Conditions
- Topical Anaesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Innoture LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To look at the effect on patient perceived pain resulting from infiltration injection with local anaesthetic in a dental syringe with prior application of topical anaesthetic to the oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the safety of the patches when applied to the oral mucosa.
Detailed description
This is a randomised, 2 treatment, double blind design, with respect to the clinical assessor and subject, split mouth, crossover design with a negative control (patch with no microneedles).
Potential participants will be invited to attend a screening visit. At this visit participants will be asked to read and sign a Participant Information Sheet and Consent Form prior to any study procedures being performed. They will be given ample time to decide if they wish to participate in the study.
A dentally qualified clinician will record the participant's demographics, medical history, current/concomitant medications, perform an oral soft tissue examination and ensure the participant fulfils the inclusion and exclusion criteria for the study. Two areas of the mouth will be identified for assessment during the study. The areas of the mouth will be identified as S1 or S2. Site S1 will be left or right palatal mucosa adjacent to the premolar area and S2 will be left or right upper buccal mucosa adjacent to the upper lateral incisor area.
Participants who successfully fulfil all the necessary entrance criteria will be provided with training by study staff on how to use a VAS record sheet and randomised on to the study to receive treatment combination A or B at in a random order according to a predetermined randomisation schedule supplied by the study statistician. The screening visit and first treatment visit will occur at the same visit. The treatment possibilities are outlined below:
Treatment A The application of a 5% topical lidocaine gel to one of the identified areas within the participants mouth using a microneedle patch. The microneedle patch will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.
Treatment B The application of a 5% topical lidocaine gel to one of the identified sites within the participants mouth using a patch with no microneedles. The patch with no microneedles will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth.
The chosen sites will be: S1; left and right palatal mucosa adjacent to the premolar area or S2; left and right upper buccal mucosa adjacent to the upper lateral incisor area. Each participant at the first visit will have either S1 or S2 sites allocated for treatment. For example, Treatment A will be allocated to S1 left side and Treatment B to S1 right side or vice versa. At the second visit, 2 weeks (+/- 3 days) after the first visit, Treatment B will be allocated to S2 left side and Treatment A to S2 right side. Both sides of the mouth for S1 or S2 will be treated at the same. After each treatment participants will be asked to make pain assessments relating to needle insertion into the oral mucosa and the giving of the local infiltration anaesthetic.
It is envisaged that a sufficient number of potential participants will be screened in order to randomise 16 onto the study.
Assessment methods: Pain assessments will be performed after application of the topical anaesthetic for 3 minutes. Each test will be performed sequentially i.e. 3 separate needle insertions, with pain assessments recorded by the participant using a Visual Analogue Scale (VAS) and a verbal pain grading after each test. The level of pain at S1 or S2 will be assessed as follows:
Test I. A short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, will be used to penetrate the oral mucosa at the treated site and the patient asked to score the pain using a VAS rating scale and by verbal grading of zero, mild, moderate or severe.
Test 2. The same needle will be inserted through the oral mucosa and down to contact bone. Pain will be assessed as in Test 1.
Test 3. The same needle will be again inserted through the oral mucosa and the cartridge of local anaesthetic will be injected into the site. Pain will be again assessed as in Test I.
Following enrolment on to the study, participants will be given written and verbal instructions on the VAS and how to complete it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A - Microneedle patch | Experimental | Device: Microneedle PatchThe application of a 5% topical lidocaine gel to one of the identified areas within the participants mouth using a microneedle patch. The microneedle patch will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth. |
| Treatment B - Patch with no microneedles | Sham comparator | Device: Patch with no microneedlesThe application of a 5% topical lidocaine gel to one of the identified sites within the participants mouth using a patch with no microneedles. The patch with no microneedles will be applied to the oral mucosa of the identified site for 3 minutes, followed by infiltration with local anaesthetic to one of the identified areas within the participants mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be aged 18 years and over, of either gender and in good health;
- be willing and physically able to carry out all study procedures;
- be willing and able to give Informed Consent and provide details of any medical history;
- be available for all of the study dates
- have a good standard of oral hygiene and gingival health
Key exclusion criteria (7 listed)
- presence of soft tissue oral pathology;
- presence of advanced periodontal disease;
- Individuals with any serious health conditions, that would preclude participation, in the professional judgement of the Study Dentist;
- individuals with known allergies or sensitivities to local anaesthetics
- have participated in another clinical trial in the last 30 days
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 |
|---|---|---|
| Microneedle PatchAt the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated. | Device | Treatment A - Microneedle patch |
| Patch with no microneedlesAt the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated. | Device | Treatment B - Patch with no microneedles |
Primary outcome
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
Time frame: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1
Time frame: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Pain levels will be recorded using a Verbal Pain Grading. For the verbal pain grading, subjects are asked to score either zero, mild, moderate or severe. In test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2
Time frame: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 2, the same needle as test 1 was inserted through the oral mucosa and down to contact bone.
Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3
Time frame: Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.
Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 3, the same needle as test 1 and test 2 was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.
1 secondary outcome
Adverse Events in Healthy Participants When a Proprietary Topical 5% Lidocaine Dental Gel Was Applied to the Oral Mucosa With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.
Time frame: Events were collected from the time of informed consent until end of treatment or when an ongoing AE had resolved whichever was latest, unless the PI & the Innoture contact from the clinical investigation plan agreed that no further follow up was needed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicola X West principal investigator
Bristol Dental School
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 Microneedle Patch and Patch with no microneedles in people with Topical Anaesthesia, run by Innoture Ltd at 1 site in United Kingdom.
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 7 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 Nov 2019. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2019). 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?
VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia. (time frame: Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.). The study lists 4 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 Nov 2019.