Contact DermatitisPhase 3NCT00640614

Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

A Phase 3 study testing T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens in people with Contact Dermatitis, run by Allerderm at 5 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Contact Dermatitis
What is being tested?: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 235 participants
Where: 5 sitesin 2 countries
Study dates: Apr 2008to Oct 2009
Phase: Phase 3
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

Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
Gold sodium thiosulfate
Methyldibromoglutaronitrile (alone or with phenoxyethanol)
Bacitracin
Bronopol

Show all 12Show fewer

Disperse blue 106 (alone or with Disperse blue 124)
Parthenolide (or Compositae mix)
Hydrocortisone-17-butyrate
All subjects must be adults over 18 years of age, and otherwise in good health.
Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Who cannot join

Subjects unable to meet inclusion requirements.
Women who are breastfeeding or pregnant.
Topical corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.
Treatment with ultraviolet (UV) light (including tanning) during the 21 days before visit
Acute dermatitis outbreak or dermatitis on or near the test area on the back.
Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

River City Dermatology
Little Rock, Arkansas, 72205
Dermatology Specialists PSC
Louisville, Kentucky, 40202-1864
Winthrop University Hospital
Mineola, New York, 11501
American Dermatology Associates
Shawnee Mission, Kansas, 66216

Other trials in United States

Denmark1 site

Odense University Hospital
Odense C, DK-5000

Other trials in Denmark

About this study

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol

We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Read the detailed description

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:

Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.
Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:

The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.
The frequency of adverse events and serious adverse events.

Conditions: Contact Dermatitis
Being tested: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Keywords: Dermatitis, Contact
Medical subject headings: Dermatitis, Contact

What participants receive

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

T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensBiological
Also called T.R.U.E. TEST® Skin Patch Test: Panel 3.2
Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP
Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Study groups in NCT00640614
Study group	Role	What they receive
Sensitives	Experimental	Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria. Receives: Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Consecutives	Experimental	Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study. Receives: Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

What is being measured

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

Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate
Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bacitracin
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Parthenolide
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bronopol
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Measured: Visit 5: 21 days after patch application

Secondary outcomes (3)

Safety Evaluations: All T.R.U.E. Test Allergens
Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.
Measured: Day 2: 48 hours after application
Late Reactions: All T.R.U.E. Test Allergens
Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).
Measured: 7-10 days after patch application
Persistent Reactions: All T.R.U.E. Test Allergens
Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)
Measured: initially occur 2-4 days after application and last through 7-21days after patch application

Timeline

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

Apr 2008Oct 2009

First posted21 Mar 2008 (estimated)
Study startApr 2008
Primary completionAug 2009
Study completionOct 2009

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 Contact DermatitisStudies 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 3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00640614
Sponsor's protocol ID: Mekos 07 7P3.2 301
Other IDs: 2008-000168-18, WIRB Pr. No.: 20080089, 2008
Status last verified: Apr 2020
First submitted: 3 Mar 2008
Last updated: 5 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
Not yet recruitingPhase 4
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All Contact Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol
ClinicalTrials.gov ID: NCT00640614
Acronym / sponsor ID: Mekos 07 7P3.2 301
Conditions: Contact Dermatitis
Keywords: Dermatitis, Contact
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: AllerdermIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Aug 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 21 Mar 2008 (estimated)
Results: Posted 22 Dec 2015

Clinical summary

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

Detailed description

Primary endpoint:

Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.
Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.
The frequency of adverse events and serious adverse events.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sensitives	Experimental	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensSubjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
Consecutives	Experimental	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensSubjects who are being seen for standard allergy patch testing, that are asked to participate in the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
All subjects must be adults over 18 years of age, and otherwise in good health.
Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

Key exclusion criteria (8 listed)

Subjects unable to meet inclusion requirements.
Women who are breastfeeding or pregnant.
Topical corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.

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
T.R.U.E. TEST® Skin Patch Test: Dose Response AllergensAlso: T.R.U.E. TEST® Skin Patch Test: Panel 3.2Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.	Biological	Consecutives, Sensitives

Primary outcome

Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.
Diagnostic Performance: Concordance
Time frame: Visit 5: 21 days after patch application
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate
Time frame: Visit 5: 21 days after patch application
Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Bacitracin
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Parthenolide
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Bronopol
Time frame: Visit 5: 21 days after patch application
The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

3 secondary outcomes

Safety Evaluations: All T.R.U.E. Test Allergens
Time frame: Day 2: 48 hours after application
Late Reactions: All T.R.U.E. Test Allergens
Time frame: 7-10 days after patch application
Persistent Reactions: All T.R.U.E. Test Allergens
Time frame: initially occur 2-4 days after application and last through 7-21days after patch application

Results and safety

Results posted to the registry on 22 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sensitives	125	124
Consecutives	110	110

Primary outcome: Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21

Time frame: Visit 5: 21 days after patch application. Number (95% Confidence Interval). Unit: percentage of concordant responses

Measure	Concordance n = 19
Value	78.9 (54.4 to 93.9)

Population analysed: Subjects with past positive patch test results to gold sodium thiosulfate

Primary outcome: Diagnostic Performance: Concordance

Time frame: Visit 5: 21 days after patch application. Number (95% Confidence Interval). Unit: percentage of concordant responses

Measure	Concordance n = 20
Value	90 (68.3 to 96.6)

Population analysed: Subjects with past positive patch test results to hydrocortizone-17-butyrate

Primary outcome: Diagnostic Performance: Concordance

Time frame: Visit 5: 21 days after patch application. Number (95% Confidence Interval). Unit: percentage of concordant responses

Measure	Concordance n = 29
Value	62.1 (42.3 to 79.3)

Population analysed: Subjects with past positive patch test results to methyldibromo-glutaronitrile

Primary outcome: Diagnostic Performance: Concordance

Time frame: Visit 5: 21 days after patch application. Number (95% Confidence Interval). Unit: percentage of concordant responses

Measure	Concordance n = 24
Value	75 (53.3 to 90.2)

Population analysed: Subjects with past positive patch test results to bacitracin

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 21. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sensitives	0 of 125 (0%)	8 of 125 (6.4%)	Not reported
Consecutives	0 of 110 (0%)	2 of 110 (1.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Contact Dermatitis

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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.

Evy Paulsen, M.D., Ph.D principal investigator

Odense University Hospital

Joseph Fowler, MD principal investigator

Dermatology Specialists PSC

Luz Fonacier, MD principal investigator

Winthrop University

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens in people with Contact Dermatitis, run by Allerderm at 5 sites in 2 countries.

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 12 inclusion and 8 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Dec 2015). 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?

Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 (time frame: Visit 5: 21 days after patch application). The study lists 14 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 NCT00640614.

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 5 May 2020.