Dermatological Non-DiseaseFILIDONCT03990883
Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)
A study testing Princess Filler Lidocaine in people with Dermatological Non-Disease, run by Croma-Pharma GmbH at 11 sites in United States.
Trial summary
Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dermatological Non-Disease
- What is being tested?
- Princess Filler Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Jun 2019to 15 Feb 2022
- 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
- Male or female subjects, 22 years of age or older, at the Screening visit
- Subjects with two fully visible, approximately symmetrical moderate to severe NLFs (same severity) with severity scores of 2 or 3 on the 5- point NLF-SRS for both NLF as judged by the treating investigator in conjunction with the independent blinded evaluating investigator.
- Females of childbearing potential must have a negative urine pregnancy test at injection visits and must agree to use an adequate method of contraception for the duration of the clinical investigation
- Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation, including botulinum toxin injections (except glabellar or forehead botulinum toxin treatment)
- Subjects having understood the purpose and conduct of the clinical investigation and having given written informed consent
Who cannot join
- For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation
- History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic
- Since Juvéderm® Ultra XC contains trace amounts of Gram-positive bacterial proteins, subjects with history of allergies to such material can not be included in this clinical investigation
- Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders
- Known human immune deficiency virus-positive individuals
- Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
Show all 43Show fewer
- Re-current herpes simplex in the treatment area
- History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
- Uncontrolled (or instable) diabetes mellitus or systemic diseases
- Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) area of device application
- Implantation of facial dermal fillers in the treatment area in the preceding twelve months
- Skin of the nasolabial region affected by aesthetic treatments (e.g. laser therapy, absorbable and non-absorbable sutures (threads), microneedling and/or botulinum toxin within the last twelve months, dermabrasion and mesotherapy within the last six months, chemical peeling within the last three months) or planning to undergo such procedures during the clinical investigation
- Facial lypolysis, including submental fat treatments, within last month prior to enrollment and during the clinical investigation
- Bariatric surgery within 12 months prior to enrollement and during the clinical investigation
- History of bleeding disorders and/or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
- Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior injection and to a minimum of four weeks post injection
- Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the treating investigator
- Previous enrollment in this clinical investigation
- Current participation in another clinical investigation, or treatment with any investigational drug/medical device within 30 days prior to clinical investigation enrollment
- Any dependency of the subject to the treating investigator, the blinded independent evaluating investigator or clinical investigation site (e.g. employees of the sponsor), or subjects who are employees or relatives of the treating investigator and/or the independent blinded evaluating investigator
- Subjects who have one of the following assessments during the visual examinations at Baseline:
- Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
- Repeat Treatment - Inclusion Criteria:
- In the opinion of the treating investigator, the subject has returned to sufficient severity of both NLFs that would have qualified him for enrollment into the clinical investigation initially (note that the subject does not have to return to his Baseline severity to be permitted to receive a repeat treatment)
- Subjects with NLFs with severity scores of 2 or 3 on the 5-point NLF-SRS for both NLFs as judged by the treating investigator in conjunction with the independent blinded evaluating investigator (note that it is not necessary for the treating and evaluating investigator to agree on the same rating)
- Females of childbearing age must have a negative urine pregnancy test at the repeat-treatment visit and must agree to continue to use an adequate method of contraception for the duration of the clinical investigation
- Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation and/or injection
- Repeat Treatment - Exclusion Criteria:
- Occurrence of an SAE or adverse event of special interest (AESI; i.e., changes in vision [loss of vision, blurriness, double vision, pain in or around the eye, blindness, blind spots, problems moving the eyes, change in peripheral vision], skin changing color around the eyelids or around the site of injection) during or after the initial injection and/or touch-up injection
- Subjects who experienced visual changes or other serious medical conditions during or after the initial/touch-up injection
- Subjects who have one of the following assessments during the visual examinations:
- Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable)
- abnormal confrontational visual field test
- abnormal ocular motility test
- Subjects who became pregnant since start of the study or are planning to become pregnant during the clinical investigation
- Known human immune deficiency virus-positive individuals
- Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
- Development of recurrent herpes simplex in the treatment area since study start
- Development of any autoimmune or connective tissue disease since start of participation in the study, or current treatment with immunomodulating therapy
- Development of uncontrolled (or instable) diabetes mellitus or any other systemic disease since study start
- Development of a bleeding disorder since study start or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
- Planned dental/oral surgery or modification (bridge-work, implants) within 2 weeks prior to injection and to a minimum of four weeks post injection
- Any medical condition prohibiting the inclusion for repeat treatment according to the judgement of the treating investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
John Joseph
Beverly Hills, California, 91436
Gary Monheit
Birmingham, Alabama, 35205
Jeremy Green
Coral Gables, Florida, 33146
Joel Cohen
Greenwood Village, Colorado, 80111
Robert Weiss
Hunt Valley, Maryland, 21030
Jeanine Downie
Montclair, New Jersey, 07042
Michael Gold
Nashville, Tennessee, 37215
The Center for Dermatology Cosmetic and Laser Surgery
New York, New York, 10549
Susan Taylor
Philadelphia, Pennsylvania, 19104
Sabrina Fabi
San Diego, California, 92121
Ava Shamban
Santa Monica, California, 90404
About this study
Official title: A Randomized, Subject- and Evaluating Investigator-blinded, Controlled, Multicenter, Split-face, Comparison Clinical Investigation to Evaluate Effectiveness and Safety of Princess FILLER Lidocaine in the Correction of Nasolabial Folds
Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds
Read the detailed description
Clinical Investigation to assess the effectiveness of "Princess Filler Lidocaine" in reducing the severity of nasolabial folds compared to "Juvederm Ultra XC", based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments
- Conditions
- Dermatological Non-Disease
- Being tested
- Princess Filler Lidocaine
- Keywords
- nasolabial folds, correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Princess Filler LidocaineDevice
correction of nasolabial folds
| Study group | Role | What they receive |
|---|---|---|
| Treatment of device 1 on left side | Other | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to left NLF, Comparator is assigned to right NLF Receives: Device: Princess Filler Lidocaine |
| Treatment of device 1 on right side | Other | Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to right NLF, Comparator is assigned to left NLF Receives: Device: Princess Filler Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This primary outcome measure is assessed first in a hierarchical testing sequence.
Measured: Week 24
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025).
Measured: Week 24
Secondary outcomes (6)
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025).
Measured: Week 24
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025).
Measured: Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Measured: Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme).
Hierarchical Testing Procedure:
This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Measured: Week 24
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24
The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Measured: Week 24
Improvement Over Baseline Based on Subject Assessment at Week 24
The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start4 Jun 2019
- Primary completion29 May 2020
- Study completion15 Feb 2022
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 Dermatological Non-DiseaseStudies 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
- Pivotal study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- David Bank, MD, Principal investigator, Center of Dermatology, Cosmetic and Laser SurgeryJoel Cohen, MD, Principal investigator, AboutSkin research, LLCJohn Joseph, MDE, Principal investigator, Dr. John Joseph Facial Plastic and Reconstructive SurgeryGary Monheit, MD, Principal investigator, Total Skin and Beauty Dermatology CenterAva Shamban, MD, Principal investigator, Ava MDSusan Taylor, MD, Principal investigator, University of PennsylvaniaRobert Weiss, MD, Principal investigator, Maryland Laser Skin and VeinSabrina Fabi, MD, Principal investigator, Cosmetic, Lazer, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990883
- Sponsor's protocol ID
- CPH 301-201200F
- Acronym
- FILIDO
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject- and Evaluating Investigator-blinded, Controlled, Multicenter, Split-face, Comparison Clinical Investigation to Evaluate Effectiveness and Safety of Princess FILLER Lidocaine in the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03990883
- Acronym / sponsor ID
- FILIDO / CPH 301-201200F
- Conditions
- Dermatological Non-Disease
- Keywords
- nasolabial folds, correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds
Detailed description
Clinical Investigation to assess the effectiveness of "Princess Filler Lidocaine" in reducing the severity of nasolabial folds compared to "Juvederm Ultra XC", based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pivotal study
| Arm | Type | Receives |
|---|---|---|
| Treatment of device 1 on left side | Other | Device: Princess Filler LidocaineTreatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to left NLF, Comparator is assigned to right NLF |
| Treatment of device 1 on right side | Other | Device: Princess Filler LidocaineTreatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to right NLF, Comparator is assigned to left NLF |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, 22 years of age or older, at the Screening visit
- Subjects with two fully visible, approximately symmetrical moderate to severe NLFs (same severity) with severity scores of 2 or 3 on the 5- point NLF-SRS for both NLF as judged by the treating investigator in conjunction with the independent blinded evaluating investigator.
- Females of childbearing potential must have a negative urine pregnancy test at injection visits and must agree to use an adequate method of contraception for the duration of the clinical investigation
- Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation, including botulinum toxin injections (except glabellar or forehead botulinum toxin treatment)
Key exclusion criteria (43 listed)
- For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation
- History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic
- Since Juvéderm® Ultra XC contains trace amounts of Gram-positive bacterial proteins, subjects with history of allergies to such material can not be included in this clinical investigation
- Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders
- Known human immune deficiency virus-positive individuals
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 |
|---|---|---|
| Princess Filler Lidocainecorrection of nasolabial folds | Device | Treatment of device 1 on left side, Treatment of device 1 on right side |
Primary outcome
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset
Time frame: Week 24
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence.
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset
Time frame: Week 24
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025).
6 secondary outcomes
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset
Time frame: Week 24
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset
Time frame: Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set
Time frame: Week 24
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set
Time frame: Week 24
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24
Time frame: Week 24
Improvement Over Baseline Based on Subject Assessment at Week 24
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Bank, MD principal investigator
Center of Dermatology, Cosmetic and Laser Surgery
Joel Cohen, MD principal investigator
AboutSkin research, LLC
John Joseph, MDE principal investigator
Dr. John Joseph Facial Plastic and Reconstructive Surgery
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Princess Filler Lidocaine in people with Dermatological Non-Disease, run by Croma-Pharma GmbH at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 43 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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 4 Feb 2025). 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?
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset (time frame: Week 24). 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?
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 4 Feb 2025.