Primary Axillary HyperhidrosisNCT04599907

Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

A study testing Roll-In Cohort: Single Application of N-SWEAT Patch and Randomized Cohort: Single Application of N-SWEAT Patch in people with Primary Axillary Hyperhidrosis, run by Candesant Biomedical, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Primary Axillary Hyperhidrosis
What is being tested?: Roll-In Cohort: Single Application of N-SWEAT Patch and Randomized Cohort: Single Application of N-SWEAT Patch
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 9 sitesUnited States
Study dates: 13 Oct 2020to 20 Dec 2021
Phase: Interventional
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed written informed consent
At least 22 years old at the time of consent.
Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
GSP >50mg/5min in each axilla
Reports a score of HDSS score of 3 or 4

Who cannot join

Active skin disease, irritation, or abrasions at either axilla based
Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
GSP exceeds 300 mg/5min in either axilla

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Skincare Physicians
Boston, Massachusetts, 02467
Research Your Health
Dallas, Texas, 75093
CA Dermatology & Clinical Research Inst
Encinitas, California, 92024
Center for Dermatology Clinical Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services, Zoe Draelos, MD
High Point, North Carolina, 27262
Pariser Derm / Virginia Clinical Research
Norfolk, Virginia, 23502
AE Derm
Rockville, Maryland, 20850
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

About this study

Official title: An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Read the detailed description

The Sahara Study is intended to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Safety of the N-SWEAT Patch will be confirmed by assessing the occurrence of local skin reactions, treatment-related adverse events (AEs) and Serious Adverse Events (SAEs).

Demonstration of effectiveness will be assessed by a significant improvement (reduction) in Hyperhidrosis Disease Severity Score (HDSS) in subjects treated with the N-SWEAT Patch. Secondary and additional endpoints based on complementary clinical instruments, including Quality of Life Measures (QOL) and Gravimetric Sweat Production GSP), have been included to further demonstrate performance.

Conditions: Primary Axillary Hyperhidrosis
Being tested: Roll-In Cohort: Single Application of N-SWEAT Patch, Randomized Cohort: Single Application of N-SWEAT Patch, Randomized Cohort: Single Application of Sham Patch
Keywords: Excessive Axillary Sweating, Primary Axillary Hyperhidrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roll-In Cohort: Single Application of N-SWEAT PatchDevice
Single Application of N-SWEAT Patch in both axillae for 10 subjects
Randomized Cohort: Single Application of N-SWEAT PatchDevice
Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
Randomized Cohort: Single Application of Sham PatchDevice
Single Application of Sham Patch in both axillae for subjects randomized to the control group

Study groups in NCT04599907
Study group	Role	What they receive
Roll-In Cohort: N-SWEAT Patch	Experimental	Subjects will be treated with N-SWEAT Patch Receives: Device: Roll-In Cohort: Single Application of N-SWEAT Patch
Randomized Cohort: N-SWEAT Patch	Experimental	Subjects will be treated with N-SWEAT Patch Receives: Device: Randomized Cohort: Single Application of N-SWEAT Patch
Randomized Cohort: Sham Patch	Sham comparator	Subjects will undergo identical procedure with an inactive sham device Receives: Device: Randomized Cohort: Single Application of Sham Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of the N-SWEAT Patch
Number of patients with Adverse Events and/or Skin reactions following patch treatment
Measured: 4 weeks
Effectiveness of the N-SWEAT Patch to Change Subjects From an HDSS 3 or 4 at Baseline to HDSS 1 or 2 at 4 Weeks
Achievement of Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at 4 weeks.
HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis.
SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and and always interferes with my daily activities
Measured: 4 weeks

Secondary outcomes (3)

Mean Change in the Quality of Life. Assessed by Evaluating How Much Sweat Bothers or Impacts the Daily Life of Patients (a Higher Score Means More Bother and More Impact)
Two Quality of Life (QoL) Assessments were conducted as part of this endpoint. The Level of Bother: Subjects were asked how much their sweat bothered them on a Scale of 1 (not at all bothered by sweating) to 5 (extremely bothered by sweating). The Impact of Sweat on Daily Activities: Subjects were asked how much their sweating impacts their daily activities on a scale of 1 (not at all impacted) to 5 (extremely impacted).
The mean improvement of each of these was calculated by comparing the mean baseline level to the mean level at 4 weeks. The mean change in the level of improvement was analyzed for significance. A larger decrease in these levels, i.e. less bother and less impact, (indicated by a larger negative number) will show the most improvement in QoL.
Measured: 4 weeks
Percentage of Patients With a Mean Change in Gravimetric Sweat Production (GSP) Indicating That Sweating After Treatment is Cut in Half From Pre-treatment Sweat
Gravimetric Sweat Production (GSP) measures the amount of sweat that is produced in a 5-minute period. The percentage of treated subjects with at least a 50% reduction in mean GSP (mean of both axilla) from baseline to 4 weeks was analyzed for this endpoint.
Measured: 4 weeks
Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
Patients with a 2-point decrease in HDSS indicate improvement in sweating.
HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis.
SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and always interferes with my daily activities
Measured: 4-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 202020 Dec 2021

First posted23 Oct 2020
Study start13 Oct 2020
Primary completion6 Jul 2021
Study completion20 Dec 2021

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.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Primary Axillary HyperhidrosisStudies 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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04599907
Sponsor's protocol ID: CB-CLP-001
Status last verified: Aug 2023
First submitted: 6 Oct 2020
Last updated: 7 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016 Dec;308(10):743-749. doi: 10.1007/s00403-016-1697-9. Epub 2016 Oct 15.
PubMed 27744497
Glaser DA, Coleman WP 3rd, Fan LK, Kaminer MS, Kilmer SL, Nossa R, Smith SR, O'Shaughnessy KF. A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Dermatol Surg. 2012 Feb;38(2):185-91. doi: 10.1111/j.1524-4725.2011.02250.x. Epub 2012 Jan 30.
PubMed 22289389
Glaser DA, Hebert A, Pieretti L, Pariser D. Understanding Patient Experience With Hyperhidrosis: A National Survey of 1,985 Patients. J Drugs Dermatol. 2018 Apr 1;17(4):392-396.
PubMed 29601615
Hamm H. Impact of hyperhidrosis on quality of life and its assessment. Dermatol Clin. 2014 Oct;32(4):467-76. doi: 10.1016/j.det.2014.06.004. Epub 2014 Jul 16.
PubMed 25152339
Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
PubMed 15280848
Stander M, Wallis LA. The emergency management and treatment of severe burns. Emerg Med Int. 2011;2011:161375. doi: 10.1155/2011/161375. Epub 2011 Sep 4.
PubMed 22046536
Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.
PubMed 15280843
Wade R, Rice S, Llewellyn A, Moloney E, Jones-Diette J, Stoniute J, Wright K, Layton AM, Levell NJ, Stansby G, Craig D, Woolacott N. Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis. Health Technol Assess. 2017 Dec;21(80):1-280. doi: 10.3310/hta21800.
PubMed 29271741
Wilke K, Martin A, Terstegen L, Biel SS. A short history of sweat gland biology. Int J Cosmet Sci. 2007 Jun;29(3):169-79. doi: 10.1111/j.1467-2494.2007.00387.x.
PubMed 18489347

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Safety and Effectiveness of the N-SWEAT Patch for the Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
ClinicalTrials.gov ID: NCT04599907
Acronym / sponsor ID: CB-CLP-001
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive Axillary Sweating, Primary Axillary Hyperhidrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Candesant Biomedical, Inc.Industry (pharma, biotech, devices)
Study start: 13 Oct 2020 (actual)
Primary completion: 6 Jul 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 7 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Detailed description

The Sahara Study is intended to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.

Safety of the N-SWEAT Patch will be confirmed by assessing the occurrence of local skin reactions, treatment-related adverse events (AEs) and Serious Adverse Events (SAEs).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Roll-In Cohort: N-SWEAT Patch	Experimental	Device: Roll-In Cohort: Single Application of N-SWEAT PatchSubjects will be treated with N-SWEAT Patch
Randomized Cohort: N-SWEAT Patch	Experimental	Device: Randomized Cohort: Single Application of N-SWEAT PatchSubjects will be treated with N-SWEAT Patch
Randomized Cohort: Sham Patch	Sham comparator	Device: Randomized Cohort: Single Application of Sham PatchSubjects will undergo identical procedure with an inactive sham device

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Signed written informed consent
At least 22 years old at the time of consent.
Female or male, who experiences excessive sweating or has been diagnosed with primary axillary focal hyperhidrosis and is in otherwise good general health
GSP >50mg/5min in each axilla
Reports a score of HDSS score of 3 or 4

Key exclusion criteria (3 listed)

Active skin disease, irritation, or abrasions at either axilla based
Subject's medical history is indicative of secondary or diffuse hyperhidrosis and/or subject has a diagnosis of secondary or diffuse hyperhidrosis
GSP exceeds 300 mg/5min in either axilla

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
Roll-In Cohort: Single Application of N-SWEAT PatchSingle Application of N-SWEAT Patch in both axillae for 10 subjects	Device	Roll-In Cohort: N-SWEAT Patch
Randomized Cohort: Single Application of N-SWEAT PatchSingle Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group	Device	Randomized Cohort: N-SWEAT Patch
Randomized Cohort: Single Application of Sham PatchSingle Application of Sham Patch in both axillae for subjects randomized to the control group	Device	Randomized Cohort: Sham Patch

Primary outcome

Safety of the N-SWEAT Patch
Time frame: 4 weeks
Number of patients with Adverse Events and/or Skin reactions following patch treatment
Effectiveness of the N-SWEAT Patch to Change Subjects From an HDSS 3 or 4 at Baseline to HDSS 1 or 2 at 4 Weeks
Time frame: 4 weeks
Achievement of Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at 4 weeks. HDSS is a disease-specific diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS 3 or 4 are generally considered to have a clinically significant case and those with HDSS 1 or 2 are considered to have mild to no evidence of hyperhidrosis. SCALE: 1 - My sweating is never noticeable and never interferes with my daily activities 2- My sweating is tolerable but sometimes interferes with my daily activities 3- My sweating is barely tolerable and frequently interferes with my daily activities 4- My sweating is intolerable and and always interferes with my daily activities

3 secondary outcomes

Mean Change in the Quality of Life. Assessed by Evaluating How Much Sweat Bothers or Impacts the Daily Life of Patients (a Higher Score Means More Bother and More Impact)
Time frame: 4 weeks
Percentage of Patients With a Mean Change in Gravimetric Sweat Production (GSP) Indicating That Sweating After Treatment is Cut in Half From Pre-treatment Sweat
Time frame: 4 weeks
Percentage of Patients With a 2-point Change in HDSS to Show That Sweat is Less Clinically Significant After Treatment
Time frame: 4-weeks

Results and safety

Results posted to the registry on 7 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roll-In Cohort: N-SWEAT Patch	10	9
Randomized Cohort: N-SWEAT Patch	53	45
Randomized Cohort: Sham Patch	57	51

Primary outcome: Safety of the N-SWEAT Patch

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	N-SWEAT Patch Treated n = 63	Randomized Cohort: Sham Patch n = 57
Value	14	4

Population analysed: All subjects treated with the N-SWEAT Patch (roll-in and randomized) were combined into a single population for the safety analysis.

Primary outcome: Effectiveness of the N-SWEAT Patch to Change Subjects From an HDSS 3 or 4 at Baseline to HDSS 1 or 2 at 4 Weeks

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	Randomized Cohort: N-SWEAT Patch Treated n = 44	Randomized Cohort: Sham Patch n = 43
Value	28	19

Randomized Cohort: N-SWEAT Patch Treated vs Randomized Cohort: Sham Patch: p <0.05, Cochran-Mantel-Haenszel

Population analysed: This was conducted on the Efficacy Cohort which included only randomized/blinded subjects. Those treated in the roll-in cohort was not included in the efficacy analyses were aware of the treatment arm to which they were assigned. Additionally, subjects who were found to have been enrolled while taking a conflicting medication were excluded from the efficacy analysis in order to isolate the true device effect.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected for 12 weeks, the total duration of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-SWEAT Patch	0 of 63 (0%)	14 of 63 (22.2%)	0 of 63
Sham Patch	0 of 57 (0%)	4 of 57 (7%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27744497Doolittle J, Walker P, Mills T, Thurston J. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 2016 Dec;308(10):743-749. doi: 10.1007/s00403-016-1697-9. Epub 2016 Oct 15.
Background: PubMed 22289389Glaser DA, Coleman WP 3rd, Fan LK, Kaminer MS, Kilmer SL, Nossa R, Smith SR, O'Shaughnessy KF. A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Dermatol Surg. 2012 Feb;38(2):185-91. doi: 10.1111/j.1524-4725.2011.02250.x. Epub 2012 Jan 30.
Background: PubMed 29601615Glaser DA, Hebert A, Pieretti L, Pariser D. Understanding Patient Experience With Hyperhidrosis: A National Survey of 1,985 Patients. J Drugs Dermatol. 2018 Apr 1;17(4):392-396.
Background: PubMed 25152339Hamm H. Impact of hyperhidrosis on quality of life and its assessment. Dermatol Clin. 2014 Oct;32(4):467-76. doi: 10.1016/j.det.2014.06.004. Epub 2014 Jul 16.
Background: PubMed 15280848Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.
Background: PubMed 22046536Stander M, Wallis LA. The emergency management and treatment of severe burns. Emerg Med Int. 2011;2011:161375. doi: 10.1155/2011/161375. Epub 2011 Sep 4.
Background: PubMed 15280843Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004 Aug;51(2):241-8. doi: 10.1016/j.jaad.2003.12.040.
Background: PubMed 29271741Wade R, Rice S, Llewellyn A, Moloney E, Jones-Diette J, Stoniute J, Wright K, Layton AM, Levell NJ, Stansby G, Craig D, Woolacott N. Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis. Health Technol Assess. 2017 Dec;21(80):1-280. doi: 10.3310/hta21800.
Background: PubMed 18489347Wilke K, Martin A, Terstegen L, Biel SS. A short history of sweat gland biology. Int J Cosmet Sci. 2007 Jun;29(3):169-79. doi: 10.1111/j.1467-2494.2007.00387.x.
Individual participant dataSharing planned: No

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.

Patricia Walker, MD study director

Candesant Biomedical - Medical Monitor

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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?

Yes. Results are posted in the registry (first posted 7 Sep 2023). 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?

Safety of the N-SWEAT Patch (time frame: 4 weeks). 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?

On the ClinicalTrials.gov record for NCT04599907, which also lists 9 linked publications.

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 7 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.