Moderate or Severe Submental FullnessPhase 2AYP-101NCT03982225
Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
A Phase 2 study testing Polyene phosphatidylcholine injection in people with Moderate or Severe Submental Fullness, run by AMIpharm Co., Ltd. at 4 sites in South Korea.
Trial summary
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate or Severe Submental Fullness
- What is being tested?
- Polyene phosphatidylcholine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Jul 2019to 21 Oct 2022
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female over 19 and under 65 years old.
- Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
- Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
- Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
- Signed informed consent obtained before any study-specific procedure is performed.
Who cannot join
- Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
- Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
- Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
- Unable to undergo MRI by neurosis or general weakness.
- History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
- History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
Show all 26Show fewer
- Inflammation, scars or surgery on the injection area.
- Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal.
- Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
- History of or present symptoms of dysphagia.
- Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
- Requiring treatment of joint inflammation or a lung disease.
- Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%).
- Type 1 diabetes mellitus who needs insulin treatment.
- Autoimmune disorder as well as those who takes immunodepressant drugs.
- Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
- Thyromegaly, thyrotoxicosis, or HIV-positive.
- Diagnosed with malignant tumor within the last 5 years.
- Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase > maximum rate of normality x 2.5).
- History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
- History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening.
- History of other clinical trial studies within 3 months before screening.
- Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
- Judged to be unsuitable subject for the clinical trials.
- No or unable to using Smart phone to fill in the e-Pro.
- Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Yonsei University Health System, Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Yonsei University Health System, Gangnam Severance Hospital
Seoul, 06273
About this study
Official title: A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.
Read the detailed description
This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- Polyene phosphatidylcholine injection, Placebo
- Keywords
- Apoptosis, Lipolysis, Fat reduction, Submental fat, Polyene Phosphatidylcholine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyene phosphatidylcholine injectionDrug
Also called AYP-101
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
PlaceboDrug
Phosphate buffered saline placebo for injection
| Study group | Role | What they receive |
|---|---|---|
| 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: Polyene phosphatidylcholine injection |
| 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: Polyene phosphatidylcholine injection |
| 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm | Experimental | Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: Polyene phosphatidylcholine injection |
| Placebo 0.2 mL/1.0 cm | Placebo comparator | Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale:
0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Measured: Baseline and 12 weeks after last treatment
Secondary outcomes (11)
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline
The CR-SMFRS is defined as at least a 1-grade improvement is evaluated by independent assessor from Baseline using the following scale:
0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Measured: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4):
0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area
Change rate of reduction in pre-platysmal volume.
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area
Change rate of reduction in platysmal volume.
Measured: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale:
0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Patients are asked to rate the visual and emotional impact that the appearance of submental fullness had on their self-perception using 11-point scale range from 0 (no impact) to 10 (extreme impact).
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner
The cervical mental angle is measured using a 3D scanner photograph obtained at first and last visit.
Measured: Baseline and 12 weeks after last treatment
Patient Global Impression of Change scale (PGIC)
Patient global impression of change scale (PGIC) is to rate patients total improvement or worsening in the appearance since before the first treatment compared to final treatment with 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.
Measured: 12 weeks after last treatment
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Difference of Derriford Appearance Scale 24 (DAS24) is to measure distress and dysfunction to problems of appearance with 24 questions using 4-point from 0 (None) to 4 (more distress).
Measured: Baseline and 12 weeks after last treatment
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7-point ranging from -3 (very negative) to +3 (very positive).
Measured: Baseline and 12 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Jul 2019
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Severe Submental FullnessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMIpharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae Hyeon Lew, MD,PhD, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982225
- Sponsor's protocol ID
- AYP-101-201
- Acronym
- AYP-101
- Status last verified
- Aug 2023
- First submitted
- 5 Jun 2019
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
- ClinicalTrials.gov ID
- NCT03982225
- Acronym / sponsor ID
- AYP-101 / AYP-101-201
- Conditions
- Moderate or Severe Submental Fullness
- Keywords
- Apoptosis, Lipolysis, Fat reduction, Submental fat, Polyene Phosphatidylcholine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- AMIpharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 11 Jun 2019 (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.
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.
Detailed description
This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Drug: Polyene phosphatidylcholine injectionParticipants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Drug: Polyene phosphatidylcholine injectionParticipants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm | Experimental | Drug: Polyene phosphatidylcholine injectionParticipants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| Placebo 0.2 mL/1.0 cm | Placebo comparator | Drug: PlaceboParticipants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female over 19 and under 65 years old.
- Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
- Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
- Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
- Signed informed consent obtained before any study-specific procedure is performed.
Key exclusion criteria (26 listed)
- Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
- Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
- Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
- Unable to undergo MRI by neurosis or general weakness.
- History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
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 |
|---|---|---|
| Polyene phosphatidylcholine injectionAlso: AYP-101Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL. | Drug | 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm, 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm, 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm |
| PlaceboPhosphate buffered saline placebo for injection | Drug | Placebo 0.2 mL/1.0 cm |
Primary outcome
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
Time frame: Baseline and 12 weeks after last treatment
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
11 secondary outcomes
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline
Time frame: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area
Time frame: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner
Time frame: Baseline and 12 weeks after last treatment
Patient Global Impression of Change scale (PGIC)
Time frame: 12 weeks after last treatment
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Time frame: Baseline and 12 weeks after last treatment
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 15 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Moderate or Severe Submental Fullness
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Moderate or Severe Submental Fullness
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.
Dae Hyeon Lew, MD,PhD principal investigator
Yonsei University Health System, Severance Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyene phosphatidylcholine injection in people with Moderate or Severe Submental Fullness, run by AMIpharm Co., Ltd. at 4 sites in South Korea.
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 5 inclusion and 26 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 15 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 4 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline (time frame: Baseline and 12 weeks after last treatment). 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 15 Aug 2023.