Skin AgeingNCT07010549

Clinical and Instrumental Evaluation of the Face Biorevitalization Effect With the Medical Device Foliage Hydrofil

A study testing Hyaluronic Acid injections in people with Skin Ageing, run by Phitogen Beauty Labs SRL at 1 site in Italy.

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

Who is it for?: Ages 30 to 55 years
Conditions the study is for: Skin Ageing
What is being tested?: Hyaluronic Acid injections
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteItaly
Study dates: 27 Sep 2022to 9 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects presenting all the following inclusion criteria will be eligible to enter the study:
Generally healthy man and women, aged between 30 and 55 years (inclusive), looking for aesthetic procedures to improve the aspect of their face.
Caucasian race (skin type from I to IV as per Fitzpatrick Skin Type scale)
Visible signs of skin aging in the face (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion;
Corneometer Capacitance of the area treated < 80
Subjects wishing not to modify their lifestyle during the study period;
Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks, side effects and discomforts and willing to adhere to the study schedule (including attendance to the planned visits) and study prescriptions;
Written informed consent release prior to any study-related procedures. -

Who cannot join

Subjects presenting one or more of the following exclusion criteria will not be eligible to enter the study:
Pregnancy or breastfeeding woman or woman of childbearing potential not practicing adequate contraception.
Subjects with Fitzpatrick skin type from V to VI
Subjects with known allergy/hypersensitivity to product components.
Extensively photo damaged and aged skin according to the Investigators opinion.
Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.

Show all 23Show fewer

Immune system disorders
History of or active collagenosis (e.g. systemic lupus, erythematosis, rheumatic arthritis, skin or systemic sclerosis).
Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the first product administration.
History of cancerous or pre-cancerous lesions in the face, neck and décolletage.
Tattoo/s on the skin around the treatment site
Previous tissue augmenting therapy with non-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit.
Use of injectable revitalization preparations within 12 months prior to the baseline visit.
Use of retinoic acid within 6 months prior to the baseline visit.
Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
History of treatment with permanent filling materials.
Participation in any other clinical study within 30 days prior to the first visit or plan to participate in another clinical study during this study period.
Planned or ongoing weight reduction program during the study.
Known history of drug or alcohol abuse within 6 months prior to the baseline visit.
Known hypersensitivity to one or more components of anesthetic creams
Nicotine use during the study or stopped within 12 months before the first visit.
Any medical condition that in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, malignancy, bleeding disorder, skin diseases etc).
Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects anticipated to be unreliable, unable to return for the follow-up visits, not likely to avoid other prohibited treatments or procedures or incapable of understanding the information or instructions. -

Trial locations and contacts

1 site in 1 country.

Italy1 site

Poliambulatorio di Medicina Estetica Casa della Salute SPA, Largo XII Ottobre, 62
Genova, 16121

Other trials in Italy

About this study

this is a Post market, prospective, single arm, clinical investigation. Foliage Hydrofil is a CE marked, class III, resorbable medical device (sterile, non-pyrogenic and physiological gel) to be used for the hydration of the skin and for the correction of superficial skin imperfections of the face and body and in the process of repairing the dermal tissue. The main component of Foliage Hydrofil is HA sodium salt of non-animal origin, produced by bacterial fermentation. Each subject will receive three treatments, one vial 2mL (1.6% HA formulation) each, with Foliage Hydrofil, 3 weeks apart. Foliage Hydrofil will be injected with needles 30G 4mm only. The area treated with the study treatment will be the face. The device administration could be done after an anesthetic cream application, according to Investigator's judgement.

Primary objective

To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline. Secondary objectives
To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area at Day 21 and 42, from baseline;
To evaluate the improvement of the skin texture, skin tone, smoothing of fine lines and wrinkles in the treated area at Day 21, 42 and 98, from baseline;
To evaluate the aesthetic change from baseline as judged by the Investigator at Day 21, 42 and 98;
To evaluate the aesthetic change from baseline as judged by the subject at Day 21, 42 and 98;
To evaluate the subject's satisfaction at Day 21, 42 and 98

Safety objectives

To assess the local safety at injection site (pain, erythema, edema, bruising) of the treatment with Foliage Hydrofil;
To assess the systemic safety of the treatment with Foliage Hydrofil.

Read the detailed description

Study Visits and Assessments

Visit 1 screening - baseline- treatment start (day 1):

Subjects will be evaluated with regard to the inclusion and exclusion criteria that will allow their participation into the study. Before any study specific evaluation is carried out, subjects will receive all the information about the study by the Investigator and will sign an informed consent form.

The following activities will be performed at first visit:

Collection of demographic information
Medical and surgical history
Physical examination (focused on the skin)
Previous (in the 30 days before) and concomitant medications / treatments recording
Urine pregnancy test (where applicable)
Inclusion/exclusion criteria assessment
Photos of the treated area (before injections)
Corneometer examination of treated area (before injections)
Skin surface characteristics, texture, tone, fine lines and wrinkles (before injections)
First treatment
Local and systemic adverse events after the first treatment. The following treatment session will be scheduled three weeks later, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits.

Visit 2 (Day 21 ± 4) and Visit 3 (Day 42 ± 4):

The following activities will be done at Visit 2, and 3:

Physical examination (focused on the skin)
Change in concomitant medications / treatments recording
Photos of the treated area (before second/third injection session)
Corneometer examination of treated area (before second/third injection session)
Skin surface characteristics, texture, tone, fine lines and wrinkles (before second/third injection session)
PAIS Subject
GAIS Investigator
Second/third treatment
Adverse events (occurred since previous visit) recording
Local and systemic adverse events after the second/third treatment. The second and third treatment sessions will be scheduled three weeks apart from each other, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits. The final visit will be scheduled about 2 months after last treatment session.

Visit 4 - End of study (Day 98 ±7):

The following activities will be done at Visit 4:

Physical examination (focused on the skin)
Change in concomitant medications / treatments recording
Photos of the treated area
Corneometer examination of treated area
Skin surface characteristics, texture, tone, fine lines and wrinkles
PAIS Subject
GAIS Investigator
Overall satisfaction by subject
Adverse events (occurred since previous visit) recording. Should the subject interrupt or conclude in advance the clinical study, for any reason, a Visit 4 will be completed

Conditions: Skin Ageing
Being tested: Hyaluronic Acid injections

What participants receive

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

Hyaluronic Acid injectionsDevice
Among treatments today available, bio-revitalization is a process which triggers the skin's own, natural collagen production and cell rejuvenation through the injection of hyaluronic acid serums. This substance is hydrophilic, drawing many times its weight in water. As we age, we have less naturally produced HA in our tissues and skin dehydration becomes a telltale sign of aging. The HA owns a great hydrating power, due to this property is widely used in the biorevitalization treatments. Its use results in supple, younger-looking skin with reduced wrinkles and improved elasticity.In bio-revitalization procedures that involve intradermal micro-injections of natural HA, with a molecular weight close to the endogenous one, carried out in correspondence with the imperfections, the viscoelastic properties of HA allow to rehydrate the tissues, allowing to prevent and contrast the aging process skin and promote their remodeling.

Study groups in NCT07010549
Study group	Role	What they receive
single arm for evaluation of the skin hydration modification from baseline to Day 98.	Experimental	Each treatment session will involve multiple microinjections, with needles 30G 4mm, in the face (external corner of the eye and cheek). The amount of product injected will be up to 2 mL, according to Investigator's judgement; the microinjections will be performed at a distance of 1-2 cm from each other. An anesthetic cream could be used before injections, at Investigator's discretion. Receives: Device: Hyaluronic Acid injections

What is being measured

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

To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline
The primary endpoint of the study is the change in skin hydration from baseline to Day 98, evaluated through corneometer skin examination.
Measured: day 98

Secondary outcomes (8)

clinical performance of Foliage Hydrofil in the change of the skin hydration in the treated area at Day 21 42, from baseline
the evaluation of the change in skin hydration from baseline to Day 21 and 42, through corneometer examination.
Measured: day 21 - day 42
subject overall satisfaction
The subject will be asked "Please express your degree of satisfaction with the treatment received" through a 5-points scale (1 very much satisfied, 2 satisfied,3 not satisfied nor unsatisfied, 4 unsatisfied, 5 very unsatisfied).
Measured: Day 21, 42 and 98
skin texture changement
the investigator will evaluate in his or her own judgment the skin texture as follows: poor-good-very good
Measured: Day 21, 42 and 98
Investigator's assessment
the Investigator's aesthetic change assessment using the Global Aesthetic Improvement Scale (GAIS) as follows:
1. worse tha before treatment
2. no change
3. minimal improvement
4. good improvement
5. optimal improvement
Measured: Day 21, 42 and 98
subject's assessment
the subject's aesthetic change assessment using the Patient's Aesthetic Improvement Scale (PAIS) as follows:
1. worse
2. no change
3. somewhat improved
4. moderately improved
5. very much improved
Measured: Day 21, 42 and 98
Smoothing of fine lines
the investigator will evaluate in his or her own judgment the smoothing of fine lines as follows: poor-good-very good
Measured: Day 21, 42 and 98
skin tone changement
the investigator will evaluate in his or her own judgment the skin tone as follows: poor-sufficient-middle-good
Measured: Day 21, 42 and 98
Wrinkles modification
the investigator will evaluate in his or her own judgment the wrinkles modification as follows:
1. absent
2. slight
3. Moderate
4. Severe
5. Extreme
Measured: Day 21, 42 and 98

Timeline

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

27 Sep 20229 Feb 2023

First posted8 Jun 2025
Study start27 Sep 2022
Primary completion9 Feb 2023
Study completion9 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Skin AgeingStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07010549
Sponsor's protocol ID: FOLIAGE-2022
Status last verified: May 2025
First submitted: 20 Mar 2025
Last updated: 8 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chahine S, Marozzi B, Valle A, Michellini L, Lazzari T. Efficacy and Safety of Non-cross-Linked Hyaluronic Acid Injections for Facial Skin Biorevitalization: A Single-Center, Open-Label, Single-Arm, Uncontrolled, Post-marketing Study. Cureus. 2025 Aug 13;17(8):e90005. doi: 10.7759/cureus.90005. eCollection 2025 Aug.
PubMed 40951208

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

RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging

All Skin Ageing trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Instrumental Evaluation of the Face Biorevitalization Effect With the Medical Device Foliage Hydrofil
ClinicalTrials.gov ID: NCT07010549
Acronym / sponsor ID: FOLIAGE-2022
Conditions: Skin Ageing
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Phitogen Beauty Labs SRLIndustry (pharma, biotech, devices)
Study start: 27 Sep 2022 (actual)
Primary completion: 9 Feb 2023 (actual)
Study completion: 9 Feb 2023 (actual)
First posted: 8 Jun 2025 (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.

Primary objective

To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline. Secondary objectives
To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area at Day 21 and 42, from baseline;
To evaluate the improvement of the skin texture, skin tone, smoothing of fine lines and wrinkles in the treated area at Day 21, 42 and 98, from baseline;
To evaluate the aesthetic change from baseline as judged by the Investigator at Day 21, 42 and 98;
To evaluate the aesthetic change from baseline as judged by the subject at Day 21, 42 and 98;
To evaluate the subject's satisfaction at Day 21, 42 and 98

Safety objectives

To assess the local safety at injection site (pain, erythema, edema, bruising) of the treatment with Foliage Hydrofil;
To assess the systemic safety of the treatment with Foliage Hydrofil.

Detailed description

Study Visits and Assessments

Visit 1 screening - baseline- treatment start (day 1):

The following activities will be performed at first visit:

Collection of demographic information
Medical and surgical history
Physical examination (focused on the skin)
Previous (in the 30 days before) and concomitant medications / treatments recording
Urine pregnancy test (where applicable)
Inclusion/exclusion criteria assessment
Photos of the treated area (before injections)
Corneometer examination of treated area (before injections)
Skin surface characteristics, texture, tone, fine lines and wrinkles (before injections)
First treatment
Local and systemic adverse events after the first treatment. The following treatment session will be scheduled three weeks later, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits.

Visit 2 (Day 21 ± 4) and Visit 3 (Day 42 ± 4):

The following activities will be done at Visit 2, and 3:

Physical examination (focused on the skin)
Change in concomitant medications / treatments recording
Photos of the treated area (before second/third injection session)
Corneometer examination of treated area (before second/third injection session)
Skin surface characteristics, texture, tone, fine lines and wrinkles (before second/third injection session)
PAIS Subject
GAIS Investigator
Second/third treatment
Adverse events (occurred since previous visit) recording
Local and systemic adverse events after the second/third treatment. The second and third treatment sessions will be scheduled three weeks apart from each other, with a window of ± 4 days. The subject will be solicited to contact the Investigator for any problem between visits. The final visit will be scheduled about 2 months after last treatment session.

Visit 4 - End of study (Day 98 ±7):

The following activities will be done at Visit 4:

Physical examination (focused on the skin)
Change in concomitant medications / treatments recording
Photos of the treated area
Corneometer examination of treated area
Skin surface characteristics, texture, tone, fine lines and wrinkles
PAIS Subject
GAIS Investigator
Overall satisfaction by subject
Adverse events (occurred since previous visit) recording. Should the subject interrupt or conclude in advance the clinical study, for any reason, a Visit 4 will be completed

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single arm for evaluation of the skin hydration modification from baseline to Day 98.	Experimental	Device: Hyaluronic Acid injectionsEach treatment session will involve multiple microinjections, with needles 30G 4mm, in the face (external corner of the eye and cheek). The amount of product injected will be up to 2 mL, according to Investigator's judgement; the microinjections will be performed at a distance of 1-2 cm from each other. An anesthetic cream could be used before injections, at Investigator's discretion.

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subjects presenting all the following inclusion criteria will be eligible to enter the study:
Generally healthy man and women, aged between 30 and 55 years (inclusive), looking for aesthetic procedures to improve the aspect of their face.
Caucasian race (skin type from I to IV as per Fitzpatrick Skin Type scale)
Visible signs of skin aging in the face (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion;
Corneometer Capacitance of the area treated < 80

Key exclusion criteria (23 listed)

Subjects presenting one or more of the following exclusion criteria will not be eligible to enter the study:
Pregnancy or breastfeeding woman or woman of childbearing potential not practicing adequate contraception.
Subjects with Fitzpatrick skin type from V to VI
Subjects with known allergy/hypersensitivity to product components.
Extensively photo damaged and aged skin according to the Investigators opinion.

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
Hyaluronic Acid injectionsAmong treatments today available, bio-revitalization is a process which triggers the skin's own, natural collagen production and cell rejuvenation through the injection of hyaluronic acid serums. This substance is hydrophilic, drawing many times its weight in water. As we age, we have less naturally produced HA in our tissues and skin dehydration becomes a telltale sign of aging. The HA owns a great hydrating power, due to this property is widely used in the biorevitalization treatments. Its use results in supple, younger-looking skin with reduced wrinkles and improved elasticity.In bio-revitalization procedures that involve intradermal micro-injections of natural HA, with a molecular weight close to the endogenous one, carried out in correspondence with the imperfections, the viscoelastic properties of HA allow to rehydrate the tissues, allowing to prevent and contrast the aging process skin and promote their remodeling.	Device	single arm for evaluation of the skin hydration modification from baseline to Day 98.

Primary outcome

To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline
Time frame: day 98
The primary endpoint of the study is the change in skin hydration from baseline to Day 98, evaluated through corneometer skin examination.

8 secondary outcomes

clinical performance of Foliage Hydrofil in the change of the skin hydration in the treated area at Day 21 42, from baseline
Time frame: day 21 - day 42
subject overall satisfaction
Time frame: Day 21, 42 and 98
skin texture changement
Time frame: Day 21, 42 and 98
Investigator's assessment
Time frame: Day 21, 42 and 98
subject's assessment
Time frame: Day 21, 42 and 98
Smoothing of fine lines
Time frame: Day 21, 42 and 98
skin tone changement
Time frame: Day 21, 42 and 98
Wrinkles modification
Time frame: Day 21, 42 and 98

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Derived from this study: PubMed 40951208Chahine S, Marozzi B, Valle A, Michellini L, Lazzari T. Efficacy and Safety of Non-cross-Linked Hyaluronic Acid Injections for Facial Skin Biorevitalization: A Single-Center, Open-Label, Single-Arm, Uncontrolled, Post-marketing Study. Cureus. 2025 Aug 13;17(8):e90005. doi: 10.7759/cureus.90005. eCollection 2025 Aug.

Related trials for Skin Ageing

RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging

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.

Tiziana Lazzari principal investigator

Poliambulatorio di Medicina Estetica Casa della Salute SPA Largo XII Ottobre, 62 16121 GENOVA

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

Questions about this trial

What is this clinical trial studying?

A study testing Hyaluronic Acid injections in people with Skin Ageing, run by Phitogen Beauty Labs SRL at 1 site in Italy.

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 8 inclusion and 23 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 8 Jun 2025. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the clinical performance of Foliage Hydrofil in the improvement of the skin hydration in the treated area (face) at Day 98, from baseline (time frame: day 98). 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 NCT07010549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.