MelasmaNCT07667972
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
A study testing Microfocused Ultrasound Treatment in people with Melasma and Rosacea, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This clinical study will evaluate the efficacy and safety of microfocused ultrasound treatment in patients with facial pigmentary diseases and rosacea. The study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Melasma, Rosacea, Periorbital Hyperpigmentation
- What is being tested?
- Microfocused Ultrasound Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants aged 20 to 60 years.
- Diagnosed by the investigator as having facial pigmentary disease or rosacea eligible for this study.
- Participants with rosacea must meet the diagnostic criteria of the Chinese Guideline for the Diagnosis and Treatment of Rosacea (2021 edition).
- Participants with facial pigmentary diseases must be diagnosed by two dermatologists with associate senior professional title or above, based on clinical manifestations and, when necessary, auxiliary examinations such as Wood's lamp examination, dermoscopy, or skin histopathology. Eligible pigmentary diseases may include melasma, periorbital hyperpigmentation, melanosis, lichen planus pigmentosus, or other facial pigmentary diseases considered suitable for this study.
- The skin lesions are suitable for microfocused ultrasound treatment and follow-up assessment.
- Able to comply with study treatment, follow-up visits, photography, and related assessments during the study.
- Able to understand the study procedures, voluntarily participate in the study, and sign written informed consent.
Who cannot join
- Pregnant or lactating women, or women planning to become pregnant during the study period.
- Known allergy to ultrasound coupling gel or any of its excipients.
- Presence of other obvious active inflammatory skin diseases, infectious skin diseases, or other facial skin conditions that may affect efficacy evaluation, apart from the target disease of this study.
- Use within 1 month before screening of topical medications or procedures that may affect study evaluation, including but not limited to corticosteroids, calcineurin inhibitors, depigmenting agents, or energy-based treatments.
- Severe cardiac, hepatic, renal, or other important organ dysfunction, or other severe systemic diseases that, in the investigator's judgment, may affect the safety or efficacy evaluation of this study.
- Participation in another clinical trial within 30 days before screening.
- History of prolonged intense sun exposure within 1 month before screening, or expected inability to avoid significant sun exposure or outdoor exposure during the study period, which may affect study evaluation.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Sham-controlled, Assessor-blinded, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Microfocused Ultrasound in Patients With Facial Pigmentary Diseases and Rosacea
This clinical study will evaluate the efficacy and safety of microfocused ultrasound treatment in patients with facial pigmentary diseases and rosacea.
The study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomly assigned to receive either active microfocused ultrasound treatment or sham stimulation. Sham stimulation will follow the same treatment procedure as active treatment but will not deliver effective therapeutic ultrasound energy.
Participants will receive one treatment session per month for 6 months and will be followed for up to 12 months. The study will assess changes in clinical severity scores, digital skin imaging parameters, patient-reported symptoms, quality of life, and safety outcomes, including adverse events.
Read the detailed description
This is a prospective, randomized, sham-controlled, assessor-blinded, parallel-group clinical study designed to evaluate the efficacy and safety of microfocused ultrasound in patients with facial pigmentary diseases and rosacea.
The study consists of two independent disease cohorts. The facial pigmentary disease cohort will include participants with eligible facial pigmentary disorders, such as melasma, periorbital hyperpigmentation, melanosis, and lichen planus pigmentosus. The rosacea cohort will include participants who meet the diagnostic criteria for rosacea. Each cohort will be randomized separately in a 1:1 ratio to either the active microfocused ultrasound group or the sham stimulation control group.
Participants assigned to the active treatment group will receive microfocused ultrasound treatment once monthly for 6 months. The planned treatment parameters include a power range of 3.76 to 5.12 W and a frequency of 8 Hz, with each session stopped after the preset treatment endpoint is reached. Participants assigned to the sham stimulation group will undergo the same procedure, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic energy.
Efficacy assessments will include investigator-assessed clinical severity scores, patient-reported outcome measures, VISIA digital skin analysis, dermatology-related quality of life assessment, and psychological symptom assessment. Safety will be evaluated through physical examination, vital signs, and monitoring of adverse events and serious adverse events throughout the study.
An exploratory tissue sample substudy may be conducted in participants who voluntarily provide additional informed consent. This substudy is exploratory and will not affect participation in the main study or the primary efficacy analysis.
- Being tested
- Microfocused Ultrasound Treatment, Sham Microfocused Ultrasound Stimulation
- Keywords
- Microfocused ultrasound, Focused ultrasound, Melasma, Rosacea, Pigmentation, Facial skin disease
- Medical subject headings
- Melanosis, Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfocused Ultrasound TreatmentDevice
Active microfocused ultrasound treatment will be administered using an ultrasound therapy device. Treatment parameters are planned as power 3.76 to 5.12 W and frequency 8 Hz. Each treatment session will stop when the preset treatment endpoint. Treatment will be performed once monthly for 6 months.
Sham Microfocused Ultrasound StimulationDevice
Sham stimulation will use the same procedure as active microfocused ultrasound treatment, including ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but will not deliver effective therapeutic ultrasound energy.
| Study group | Role | What they receive |
|---|---|---|
| Active Microfocused Ultrasound - Pigmentary Disease Cohort | Experimental | Participants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months. Receives: Device: Microfocused Ultrasound Treatment |
| Sham Stimulation - Pigmentary Disease Cohort | Sham comparator | Participants with facial pigmentary diseases will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy. Receives: Device: Sham Microfocused Ultrasound Stimulation |
| Active Microfocused Ultrasound - Rosacea Cohort | Experimental | Participants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months. Receives: Device: Microfocused Ultrasound Treatment |
| Sham Stimulation - Rosacea Cohort | Sham comparator | Participants with rosacea will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy. Receives: Device: Sham Microfocused Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6
Change from baseline to Month 6 in the Melasma Area and Severity Index (MASI)-based pigment area and severity score in the pigmentary disease cohort. The score assesses lesion area, darkness, and homogeneity across facial regions. Total scores range from 0 to 48, with higher scores indicating more severe pigmentation.
Measured: Baseline to Month 6
Change From Baseline in Clinician's Erythema Assessment Score at Month 6
Change from baseline to Month 6 in the Clinician's Erythema Assessment (CEA) score in the rosacea cohort. The CEA score ranges from 0 to 4, where 0 indicates clear or no erythema and 4 indicates severe erythema. Higher scores indicate more severe erythema.
Measured: Baseline to Month 6
Secondary outcomes (7)
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Months 2, 4, and 12
Change from baseline to Months 2, 4, and 12 in the Melasma Area and Severity Index (MASI)-based pigment area and severity score in the pigmentary disease cohort. The score assesses lesion area, darkness, and homogeneity across facial regions. Total scores range from 0 to 48, with higher scores indicating more severe pigmentation.
Measured: Baseline to Months 2, 4, and 12
Change From Baseline in Melasma Quality of Life Scale Score
Change from baseline in the Melasma Quality of Life Scale score in the pigmentary disease cohort. The scale contains 10 items scored from 1 to 7. Total scores range from 10 to 70, with higher scores indicating worse health-related quality of life and greater disease impact.
Measured: Baseline to Months 6 and 12
Change From Baseline in Clinician's Erythema Assessment Score at Months 2, 4, and 12
Change from baseline to Months 2, 4, and 12 in the Clinician's Erythema Assessment (CEA) score in the rosacea cohort. The CEA score ranges from 0 to 4, where 0 indicates clear or no erythema and 4 indicates severe erythema. Higher scores indicate more severe erythema.
Measured: Baseline to Months 2, 4, and 12
Change From Baseline in Patient-Assessed Flushing Severity Score in the Rosacea Cohort
Change from baseline in patient-assessed flushing severity score in the rosacea cohort. Flushing is assessed using the rosacea clinical study patient assessment form. Scores range from 0 to 4, where 0 indicates none and 4 indicates always present. Higher scores indicate more frequent or more severe flushing.
Measured: Baseline to Months 6 and 12
Change From Baseline in Patient- and Investigator-Assessed Rosacea Clinical Symptom Severity Scores
Change from baseline in patient- and investigator-assessed rosacea clinical symptom severity scores. Patient-assessed symptoms are evaluated using the rosacea clinical study patient assessment form, and investigator-assessed signs are evaluated using the rosacea clinical study investigator assessment form. Each item is scored from 0 to 4. For patient-assessed items, 0 indicates none and 4 indicates always present. For investigator-assessed items, 0 indicates clear or none and 4 indicates severe. Higher scores indicate more severe rosacea symptoms or signs.
Measured: Baseline to Months 6 and 12
Change From Baseline in Dermatology Life Quality Index Score
Change from baseline in the Dermatology Life Quality Index (DLQI) score. The DLQI is a 10-item questionnaire assessing dermatology-related quality of life. Total scores range from 0 to 30, with higher scores indicating greater impairment in quality of life.
Measured: Baseline to Months 6 and 12
Change From Baseline in Patient Health Questionnaire-9 Score
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) score. The PHQ-9 contains 9 items, each scored from 0 to 3. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline to Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- This study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomized separately in a 1:1 ratio to receive either active microfocused ultrasound treatment or sham stimulation. The study uses a parallel-group design. Efficacy analyses will be conducted separately for the two disease cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian dan, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667972
- Sponsor's protocol ID
- 202509103
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant privacy protection, the sensitive nature of facial images and clinical dermatology data, and institutional data management requirements. De-identified aggregate results may be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Sham-controlled, Assessor-blinded, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Microfocused Ultrasound in Patients With Facial Pigmentary Diseases and Rosacea
- ClinicalTrials.gov ID
- NCT07667972
- Acronym / sponsor ID
- 202509103
- Keywords
- Microfocused ultrasound, Focused ultrasound, Melasma, Rosacea, Pigmentation, Facial skin disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jun 2026 (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 clinical study will evaluate the efficacy and safety of microfocused ultrasound treatment in patients with facial pigmentary diseases and rosacea.
The study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomly assigned to receive either active microfocused ultrasound treatment or sham stimulation. Sham stimulation will follow the same treatment procedure as active treatment but will not deliver effective therapeutic ultrasound energy.
Participants will receive one treatment session per month for 6 months and will be followed for up to 12 months. The study will assess changes in clinical severity scores, digital skin imaging parameters, patient-reported symptoms, quality of life, and safety outcomes, including adverse events.
Detailed description
This is a prospective, randomized, sham-controlled, assessor-blinded, parallel-group clinical study designed to evaluate the efficacy and safety of microfocused ultrasound in patients with facial pigmentary diseases and rosacea.
The study consists of two independent disease cohorts. The facial pigmentary disease cohort will include participants with eligible facial pigmentary disorders, such as melasma, periorbital hyperpigmentation, melanosis, and lichen planus pigmentosus. The rosacea cohort will include participants who meet the diagnostic criteria for rosacea. Each cohort will be randomized separately in a 1:1 ratio to either the active microfocused ultrasound group or the sham stimulation control group.
Participants assigned to the active treatment group will receive microfocused ultrasound treatment once monthly for 6 months. The planned treatment parameters include a power range of 3.76 to 5.12 W and a frequency of 8 Hz, with each session stopped after the preset treatment endpoint is reached. Participants assigned to the sham stimulation group will undergo the same procedure, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic energy.
Efficacy assessments will include investigator-assessed clinical severity scores, patient-reported outcome measures, VISIA digital skin analysis, dermatology-related quality of life assessment, and psychological symptom assessment. Safety will be evaluated through physical examination, vital signs, and monitoring of adverse events and serious adverse events throughout the study.
An exploratory tissue sample substudy may be conducted in participants who voluntarily provide additional informed consent. This substudy is exploratory and will not affect participation in the main study or the primary efficacy analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomized separately in a 1:1 ratio to receive either active microfocused ultrasound treatment or sham stimulation. The study uses a parallel-group design. Efficacy analyses will be conducted separately for the two disease cohorts.
| Arm | Type | Receives |
|---|---|---|
| Active Microfocused Ultrasound - Pigmentary Disease Cohort | Experimental | Device: Microfocused Ultrasound TreatmentParticipants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months. |
| Sham Stimulation - Pigmentary Disease Cohort | Sham comparator | Device: Sham Microfocused Ultrasound StimulationParticipants with facial pigmentary diseases will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy. |
| Active Microfocused Ultrasound - Rosacea Cohort | Experimental | Device: Microfocused Ultrasound TreatmentParticipants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months. |
| Sham Stimulation - Rosacea Cohort | Sham comparator | Device: Sham Microfocused Ultrasound StimulationParticipants with rosacea will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female participants aged 20 to 60 years.
- Diagnosed by the investigator as having facial pigmentary disease or rosacea eligible for this study.
- Participants with rosacea must meet the diagnostic criteria of the Chinese Guideline for the Diagnosis and Treatment of Rosacea (2021 edition).
- Participants with facial pigmentary diseases must be diagnosed by two dermatologists with associate senior professional title or above, based on clinical manifestations and, when necessary, auxiliary examinations such as Wood's lamp examination, dermoscopy, or skin histopathology. Eligible pigmentary diseases may include melasma, periorbital hyperpigmentation, melanosis, lichen planus pigmentosus, or other facial pigmentary diseases considered suitable for this study.
- The skin lesions are suitable for microfocused ultrasound treatment and follow-up assessment.
Key exclusion criteria (8 listed)
- Pregnant or lactating women, or women planning to become pregnant during the study period.
- Known allergy to ultrasound coupling gel or any of its excipients.
- Presence of other obvious active inflammatory skin diseases, infectious skin diseases, or other facial skin conditions that may affect efficacy evaluation, apart from the target disease of this study.
- Use within 1 month before screening of topical medications or procedures that may affect study evaluation, including but not limited to corticosteroids, calcineurin inhibitors, depigmenting agents, or energy-based treatments.
- Severe cardiac, hepatic, renal, or other important organ dysfunction, or other severe systemic diseases that, in the investigator's judgment, may affect the safety or efficacy evaluation of this 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 |
|---|---|---|
| Microfocused Ultrasound TreatmentActive microfocused ultrasound treatment will be administered using an ultrasound therapy device. Treatment parameters are planned as power 3.76 to 5.12 W and frequency 8 Hz. Each treatment session will stop when the preset treatment endpoint. Treatment will be performed once monthly for 6 months. | Device | Active Microfocused Ultrasound - Pigmentary Disease Cohort, Active Microfocused Ultrasound - Rosacea Cohort |
| Sham Microfocused Ultrasound StimulationSham stimulation will use the same procedure as active microfocused ultrasound treatment, including ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but will not deliver effective therapeutic ultrasound energy. | Device | Sham Stimulation - Pigmentary Disease Cohort, Sham Stimulation - Rosacea Cohort |
Primary outcome
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6
Time frame: Baseline to Month 6
Change from baseline to Month 6 in the Melasma Area and Severity Index (MASI)-based pigment area and severity score in the pigmentary disease cohort. The score assesses lesion area, darkness, and homogeneity across facial regions. Total scores range from 0 to 48, with higher scores indicating more severe pigmentation.
Change From Baseline in Clinician's Erythema Assessment Score at Month 6
Time frame: Baseline to Month 6
Change from baseline to Month 6 in the Clinician's Erythema Assessment (CEA) score in the rosacea cohort. The CEA score ranges from 0 to 4, where 0 indicates clear or no erythema and 4 indicates severe erythema. Higher scores indicate more severe erythema.
7 secondary outcomes
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Months 2, 4, and 12
Time frame: Baseline to Months 2, 4, and 12
Change From Baseline in Melasma Quality of Life Scale Score
Time frame: Baseline to Months 6 and 12
Change From Baseline in Clinician's Erythema Assessment Score at Months 2, 4, and 12
Time frame: Baseline to Months 2, 4, and 12
Change From Baseline in Patient-Assessed Flushing Severity Score in the Rosacea Cohort
Time frame: Baseline to Months 6 and 12
Change From Baseline in Patient- and Investigator-Assessed Rosacea Clinical Symptom Severity Scores
Time frame: Baseline to Months 6 and 12
Change From Baseline in Dermatology Life Quality Index Score
Time frame: Baseline to Months 6 and 12
Change From Baseline in Patient Health Questionnaire-9 Score
Time frame: Baseline to Months 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant privacy protection, the sensitive nature of facial images and clinical dermatology data, and institutional data management requirements. De-identified aggregate results may be reported in scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfocused Ultrasound Treatment in people with Melasma and Rosacea, run by Xiangya Hospital of Central South University at 1 site in China.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6 (time frame: Baseline to Month 6). 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 30 Jun 2026.