InflammationBENCHMARKNCT03862872
Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers
A study testing Anti-Aging Formula in people with Inflammation and Skin Abnormalities, run by Bend Beauty Inc. at 1 site in Canada.
Trial summary
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Skin Abnormalities, Skin Pigment
- What is being tested?
- Anti-Aging Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2020to Jun 2021
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of a signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 35-65 years
- Subjects with Omega-3 Index of 5 or less.
- Subjects with Chronic Inflammation Scores of 415 or greater.
Who cannot join
- Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points.
- Subjects that have consumed Anti-Aging Formula, omega-3 fatty acid (i.e. fish oil, krill oil, algal oil), lutein, zeaxanthin, carotenoids, GLA (borage or evening primrose oils) and/or Vitamin D supplements during the last 3 months
- Subjects who were ill (i.e. rhino virus, influenza, etc.) within two weeks prior to the study start, or who have any active systemic infection (infected tooth, bladder infection, sinus infection, etc.)
- Subjects taking:
- Anti-inflammatory medications including the nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase (COX)-1 and COX-2 inhibitors, such as aspirin, ibuprofen (Advil and Voltaren), and naproxen, and acetaminophen (Tylenol®), either routinely or during the 7 days before baseline urine and blood testing.
- H2 antagonist/blockers [e.g. cimetidine (Tagamet®), ranitidine (Zantac®)]
Show all 22Show fewer
- Anti-histamines [e.g. fexofenadine (Allegra®), terfenadine (Seldane®), diphenhydramine (Benadryl®), desloratadine (Clarinex®)], either routinely or during the 7 days before baseline urine and blood testing.
- Statins [e.g. atorvastatin (Lipitor®), lovastatin (Altoprev®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®)]
- Cannabinoids/Cannabis
- Corticosteroids including:
- Inhaled treatments such as beclomethasone (QVAR®), budesonide (Pulmicort®), ciclesonide (Alvesco®), fluticasone (Flovent®), mometasone (Asmanex Twisthaler®)
- Oral treatments such as Prednisone
- Injectables such as cortisone injections and IV treatments such as Humira®, Enbrel® and Remicade®
- Topical treatments such as hydrocortisone (Anusol®)
- Subjects with known allergy or intolerance to the test material ingredients (i.e. fish, soy)
- Subjects who consume fish more than twice per week
- Subjects who smoke tobacco and/or cannabis products
- Women who are pregnant or are planning to become pregnant or are lactating during the course of the study
- Subjects who have participated in a clinical trial (CT) within the past 3 months
- Subjects living in the same household as subjects that are currently enrolled within this study
- Subjects with diabetes (or taking Metformin), diagnosed arthritis, diagnosed chronic kidney disease, cancer, or with any apparent acute injury inflammation (e.g. torn rotator cuff, broken leg, severe skin abrasions).
- Subject who consume alcohol during the 12 hours before baseline urine and blood testing
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cornerstone Naturopathic Clinic, 14 Old School Rd, Upper Tantallon
Halifax, Nova Scotia, B3Z 2J6
About this study
Official title: The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
Read the detailed description
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
Subjects will be preselected through a Subject Eligibility Screening (SES) against defined inclusion and exclusion criteria for entry into the trial. Eligible participants will be tested using the Chronic Inflammation Test for urinary 11-dehydrothromboxane B2 (https://chronicinflammationtest.com) and the Omega-3 Index Test for eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in red blood cells (RBC) (https://omegaquant.com ), to confirm possible presence of chronic inflammation. If these test results meet a defined limit, participants will be enrolled in the trial.
A number of assessments will be conducted before and after treatment.
- Being tested
- Anti-Aging Formula, Control Fish Oil, Inert Placebo
- Keywords
- Inflammation, Skin, UV-light, Inflammatory markers, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Fish Oil, Gamma-linolenic acid (GLA), Borage oil, Vitamin D, Zeaxanthin, Lutein, Omega-3 Index, Chronic Inflammation Test, 11-dehydrothromboxane B2, 8-hydroxy-2' -deoxyguanosine (8- OHdG), 8-isoprostane
- Medical subject headings
- Inflammation, Skin Abnormalities, Pigmentation Disorders, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Aging FormulaDietary supplement
Also called Bend Beauty's Anti-Aging Formula
Anti-Aging Formula contains 1050 mg of EPA and 350 mg of DHA from anchovies, sardines, and/or mackerel whole body oil, 120 mg of GLA from Borage (Borago officianalis) seeds, 2.5 mg of zeaxanthin from Capsicum annuum L. fruit, 5 mg of lutein from Tagetes erecta flower, and 25 μg (1000 IU) of vitamin D3 (cholecalciferol) from lanolin per 4 capsule daily dose. This dosage form is the same as is commercially marketed in Canada under license Natural Product Number (NPN) 80077254.
Control Fish OilDietary supplement
The control fish oil is a soft gelatin capsule containing 1,106 mg of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil. A four capsule per day dose provides 816 mg EPA and 572 mg DHA, which is only slightly less EPA+DHA than is provided within a four capsule per day dose of Anti-Aging Formula. This minor difference would not be expected to alter clinical outcomes.
Inert PlaceboOther
The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Aging Formula | Experimental | 4 capsules daily of high-EPA fish oil, borage oil, zeaxanthin, lutein and vitamin D providing 1050 mg of Eicosapentaenoic acid (EPA) and 350 mg of Docosahexaenoic acid (DHA), 120 mg of Gamma-linolenic acid (GLA), 2.5 mg of zeaxanthin, 5 mg of lutein and 25 μg (1000 IU) of vitamin D3 for 90 days. Receives: Dietary Supplement: Anti-Aging Formula |
| Control Fish Oil | Active comparator | 4 capsules daily of 1,106 mg each of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil providing 816 mg EPA and 572 mg DHA total for 90 days. Receives: Dietary Supplement: Control Fish Oil |
| Inert Placebo | Placebo comparator | 4 capsules daily of 1040 mg each of corn oil for 90 days. Receives: Other: Inert Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
The concentration of 1-dehydrothromboxane B2 in urine using The Chronic Inflammation Test (https://chronicinflammationtest.com) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Omega-3 Index
The concentration of EPA+DHA expressed as the Omega-3 index (https://omegaquant.com), after treatment with Anti-Aging Formula, control fish oil and inert placebo
Measured: Baseline to 90 days
Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Urinary 8-isoprostane
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Secondary outcomes (10)
Blood pressure
Blood pressure reported as mmHg (Systolic/Diastolic) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Resting heart rate
Resting heart rate in beats per minute after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Height
Height in meters (m) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 Days
Weight
Weight in Kilograms (Kg) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
Body Mass Index (BMI)
Weight and height will be combined to calculate BMI as kg/m2 after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Measured: Baseline to 90 days
General health/function
Subjective assessment of general health/function using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. The questionnaire consists of a list of 27 questions with answers on a scale from 0-4 that cover a variety of health indicators including pain, task oriented performance, mental and emotional well-being, appetite, etc. The resulting score defines General Health/Function as
- Excellent 81-108
- Good 54-80
- Poor 27-53
- Extremely poor 0-26
Measured: Baseline to 90 days
Physical activity rating
Subjective assessment of physical activity using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. Results are expressed as how many days per week (0-7) that the Subject exercised to a defined amount, where a greater number of days is considered better.
Measured: Baseline to 90 days
Perceived health status
Subjective assessment of perceived health using an in-house designed questionnaire after treatment with Anti-Aging Formula, control fish oil and inert placebo. The results are expressed as the subjects' perceived health (degrees of good or bad) on the day that the questionnaire is completed using a scale of 0-100 where 0 is the worst imaginable health and 100 is the best imaginable health.
Measured: Baseline to 90 days
Mental well-being/depression
Subjective assessment of mental well-being/depression using the Patient Health Questionnaire-9 after treatment with Anti-Aging Formula, control fish oil and inert placebo. The Patient Health Questionnaire-9 is available in the public domain, and is employed to capture data more focused on mental health indicators of depression. It is a version of the PRIME-MD diagnostic instrument for common mental disorders, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care to monitor severity of depression and response to treatment. Results are presented as a score ranging from 0-27, where 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 is severe depression.
Measured: Baseline to 90 days
Skin Condition
Subjective assessment of skin condition using Observ 520 Skin Analysis (http://www.observ.uk.com/) after treatment with Anti-Aging Formula, control fish oil and inert placebo. Observ 520 Skin Analysis measures skin condition in the epidermal and dermal layers using skin fluorescence and polarized light illumination technology to produce visual indicators of skin's condition.The technology allows overlay of one photo on top of another to enable comparative changes before and after treatment. Numerical data will be created by comparing before and after treatment photos and assigning the descriptors: "improved", "unchanged", or "worsened" that correspond to the values +1, 0, or -1, respectively. The average numerical value from each of the three treatment arms will then be calculated and compared, which will be used as quantitative measures of the treatments' effects on skin condition.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study startFeb 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Altered research priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bend Beauty Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Connolly, ND, BSc., Principal investigator, Cornerstone Naturopathic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862872
- Sponsor's protocol ID
- CT1801
- Acronym
- BENCHMARK
- Status last verified
- Dec 2019
- First submitted
- 27 Feb 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morse NL, Reid AJ, St-Onge M. An open-label clinical trial assessing the efficacy and safety of Bend Skincare Anti-Aging Formula on minimal erythema dose in skin. Photodermatol Photoimmunol Photomed. 2018 Mar;34(2):152-161. doi: 10.1111/phpp.12350. Epub 2017 Oct 11.
PubMed 28884844
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Supplementation With Bend Beauty's Anti-Aging Formula on Inflammatory Markers
- ClinicalTrials.gov ID
- NCT03862872
- Acronym / sponsor ID
- BENCHMARK / CT1801
- Keywords
- Inflammation, Skin, UV-light, Inflammatory markers, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Fish Oil, Gamma-linolenic acid (GLA)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Altered research priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bend Beauty Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Mar 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.
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
Detailed description
This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.
Subjects will be preselected through a Subject Eligibility Screening (SES) against defined inclusion and exclusion criteria for entry into the trial. Eligible participants will be tested using the Chronic Inflammation Test for urinary 11-dehydrothromboxane B2 (https://chronicinflammationtest.com) and the Omega-3 Index Test for eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in red blood cells (RBC) (https://omegaquant.com ), to confirm possible presence of chronic inflammation. If these test results meet a defined limit, participants will be enrolled in the trial.
A number of assessments will be conducted before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study
| Arm | Type | Receives |
|---|---|---|
| Anti-Aging Formula | Experimental | Dietary Supplement: Anti-Aging Formula4 capsules daily of high-EPA fish oil, borage oil, zeaxanthin, lutein and vitamin D providing 1050 mg of Eicosapentaenoic acid (EPA) and 350 mg of Docosahexaenoic acid (DHA), 120 mg of Gamma-linolenic acid (GLA), 2.5 mg of zeaxanthin, 5 mg of lutein and 25 μg (1000 IU) of vitamin D3 for 90 days. |
| Control Fish Oil | Active comparator | Dietary Supplement: Control Fish Oil4 capsules daily of 1,106 mg each of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil providing 816 mg EPA and 572 mg DHA total for 90 days. |
| Inert Placebo | Placebo comparator | Other: Inert Placebo4 capsules daily of 1040 mg each of corn oil for 90 days. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of a signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 35-65 years
- Subjects with Omega-3 Index of 5 or less.
- Subjects with Chronic Inflammation Scores of 415 or greater.
Key exclusion criteria (22 listed)
- Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points.
- Subjects that have consumed Anti-Aging Formula, omega-3 fatty acid (i.e. fish oil, krill oil, algal oil), lutein, zeaxanthin, carotenoids, GLA (borage or evening primrose oils) and/or Vitamin D supplements during the last 3 months
- Subjects who were ill (i.e. rhino virus, influenza, etc.) within two weeks prior to the study start, or who have any active systemic infection (infected tooth, bladder infection, sinus infection, etc.)
- Subjects taking:
- Subjects with known allergy or intolerance to the test material ingredients (i.e. fish, soy)
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 |
|---|---|---|
| Anti-Aging FormulaAlso: Bend Beauty's Anti-Aging FormulaAnti-Aging Formula contains 1050 mg of EPA and 350 mg of DHA from anchovies, sardines, and/or mackerel whole body oil, 120 mg of GLA from Borage (Borago officianalis) seeds, 2.5 mg of zeaxanthin from Capsicum annuum L. fruit, 5 mg of lutein from Tagetes erecta flower, and 25 μg (1000 IU) of vitamin D3 (cholecalciferol) from lanolin per 4 capsule daily dose. This dosage form is the same as is commercially marketed in Canada under license Natural Product Number (NPN) 80077254. | Dietary supplement | Anti-Aging Formula |
| Control Fish OilThe control fish oil is a soft gelatin capsule containing 1,106 mg of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil. A four capsule per day dose provides 816 mg EPA and 572 mg DHA, which is only slightly less EPA+DHA than is provided within a four capsule per day dose of Anti-Aging Formula. This minor difference would not be expected to alter clinical outcomes. | Dietary supplement | Control Fish Oil |
| Inert PlaceboThe inert placebo is a soft gelatin capsule containing 1040 mg of corn oil. | Other | Inert Placebo |
Primary outcome
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test
Time frame: Baseline to 90 days
The concentration of 1-dehydrothromboxane B2 in urine using The Chronic Inflammation Test (https://chronicinflammationtest.com) after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Omega-3 Index
Time frame: Baseline to 90 days
The concentration of EPA+DHA expressed as the Omega-3 index (https://omegaquant.com), after treatment with Anti-Aging Formula, control fish oil and inert placebo
Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)
Time frame: Baseline to 90 days
The concentration of 8-OHdG in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
Urinary 8-isoprostane
Time frame: Baseline to 90 days
The concentration of 8-isoprostane in urine after treatment with Anti-Aging Formula, control fish oil and inert placebo.
10 secondary outcomes
Blood pressure
Time frame: Baseline to 90 days
Resting heart rate
Time frame: Baseline to 90 days
Height
Time frame: Baseline to 90 Days
Weight
Time frame: Baseline to 90 days
Body Mass Index (BMI)
Time frame: Baseline to 90 days
General health/function
Time frame: Baseline to 90 days
Physical activity rating
Time frame: Baseline to 90 days
Perceived health status
Time frame: Baseline to 90 days
Mental well-being/depression
Time frame: Baseline to 90 days
Skin Condition
Time frame: Baseline to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 28884844Morse NL, Reid AJ, St-Onge M. An open-label clinical trial assessing the efficacy and safety of Bend Skincare Anti-Aging Formula on minimal erythema dose in skin. Photodermatol Photoimmunol Photomed. 2018 Mar;34(2):152-161. doi: 10.1111/phpp.12350. Epub 2017 Oct 11.
- 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.
Ben Connolly, ND, BSc. principal investigator
Cornerstone Naturopathic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Aging Formula in people with Inflammation and Skin Abnormalities, run by Bend Beauty Inc. at 1 site in Canada.
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 22 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: withdrawn, as of the sponsor's last update on 16 Jul 2020. 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 Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test (time frame: Baseline to 90 days). 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?
On the ClinicalTrials.gov record for NCT03862872, which also lists 1 linked publication.
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 16 Jul 2020.