KeloidNCT04824612
Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery.
A study testing Photobiomodulation with blue led and Triamcinolone Hexacetonide in people with Keloid and Cicatrix, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
A randomized, controlled, double-blind, clinical trial will be conducted to study the evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Photobiomodulation with blue led and Triamcinolone Hexacetonide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2021to 30 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years;
- Fitzpatrick skin phototype I-VI;
- Keloid with no type of previous treatment;
- Recurring keloid after surgical excision;
- Recurring keloid after use of other therapies and at least three months without treatment.
Who cannot join
- Keloid in treatment;
- Pregnant and lactating women;
- Keloid with primary synthesis of the skin and no possibility of excision.
- Contraindications for undergoing surgery (e.g.: coagulopathies, diabetes myellitus, drug allergies);
- Contraindications for the use of corticosteroids;
- All types of Collagenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Combination of Photobiomodulation Therapy and the Intralesional Administration of Corticoid in the Preoperative and Postoperative Periods of Keloid Surgery: a Randomized, Controlled, Double-blind Trial
A randomized, controlled, double-blind, clinical trial will be conducted to study the evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery.
Read the detailed description
Keloid scars are characterized by the excessive proliferation of fibroblasts and an imbalance between the production and degradation of collagen, leading to its buildup in the dermis. Although the genesis of this condition is not yet fully clarified, keloids are known to have a genetic component and are related to an increase in the expression of transforming growth factor beta (TGF-β). There is no "gold standard" treatment and recurrence is frequent. Therefore, novel treatment options are needed. In vitro studies have demonstrated that photobiomodulation (PBM) reduces the multiplication velocity and quantity of fibroblasts as well as the expression of TGF-β. This is a low-cost, noninvasive therapy with no side effects that has proved to be a good tool to complement the most established treatment. Therefore, the purpose of this study is to evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery. A randomized, controlled, double-blind, clinical trial will be conducted involving two groups: 1) Sham (N = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and 2) active PBM combined with IAC (N = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). The patients will answer two questionnaires: one for the assessment of quality of life (Qualifibro-UNIFESP) and one for the assessment of satisfaction with the scar (PSAQ). The team of plastic surgeons will answer the Vancouver Scar Scale (VSS). All questionnaires will be administered one, three, six, and twelve months postoperatively. The keloids will be molded in silicone prior to the onset of treatment and prior to excision to assess pre-treatment and post-treatment size. The same will be performed for the remaining scar at one, three, six, and twelve months postoperatively. The removed keloid will be sent for histopathological analysis for the determination of the quantity of fibroblasts, the organization and distribution of collagen (picrosirius staining), and the expression of TGF-β. All data will be submitted to statistical analysis.
- Being tested
- Photobiomodulation with blue led, Triamcinolone Hexacetonide, Sham LED
- Keywords
- keloid, photobiomodulation, corticoid
- Medical subject headings
- Keloid, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation with blue ledDevice
Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J).
Triamcinolone HexacetonideDrug
intralesional injection of 20 mg/ml. two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies.
Sham LEDDevice
A blue LED without power and biologic effect.
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | intralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide (Triancil®, Apsen Farmacêutica S.A.) - two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies.
Sham PBM in the preoperative and postoperative periods of keloid removal surgery: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. Receives: Drug: Triamcinolone Hexacetonide; Device: Sham LED |
| Experimental Group | Experimental | Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). Frequency: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month.
Intralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide: two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies. Receives: Device: Photobiomodulation with blue led; Drug: Triamcinolone Hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar assessment by specialists (change in the scar of is being evaluated)
Blinded, calibrated, certified plastic surgeons will answer the Vancouver Scar Scale (VSS), which was translated into Portuguese by Santos et al. This scale focuses on four parameters:
scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 points. The VSS set a precedent for the systematic evaluation of scars, taking a semiquantitative approach to organize a collection of subjective assessments.
Measured: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
Quality of Life of the patients (change in quality of life is being evaluated)
The Quality of Life of Patients with Keloid and Hypertrophic Scarring questionnaire. The participants will answer the questionnaires. Answer choices are on a Likert Scale with the following choices: -5 (totally inaccurate), -3 (inaccurate), -1 (somewhat inaccurate), 1 (fairly accurate), 3 (accurate), 5 (completely accurate).
Measured: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
patient satisfaction with the scar (change in the quality of scar is being evaluated)
The participants will also answer Part II (classification of satisfaction) of the Patient Scar Assessment Questionnaire (PSAQ) Participant answer: Very satisfied, Satisfied Dissatisfied and Very Dissatisfied.
Measured: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
Secondary outcomes (4)
keloid and remaining scar size
Molds will be made of the scars in light condensation silicone (Zhermack, Badia Polesine, Italy). The material will be stored in acrylic dishes and sent for analysis (optical coherence tomography) for the determination of area and volume.
Measured: These procedures will be performed in baseline (preoperatively) as well as one, three, six, and twelve months postoperatively.
Fibroblasts analysis
Quantitative analysis of the fibroblasts of the keloid specimens will be performed. For such, the histological slides with the samples will be stained with hematoxylin-eosin (H.E.). This analysis is to verify the number of fibroblasts only trough visual analysis.
Measured: one time up to 4 weeks after preoperative treatment
analysis of collagen
analysis of collagen fibers will also be performed using additional slices stained with Picrosirius Red. This analysis is to verify the number of fibers of collagen and your organization only trough visual analysis.
Measured: one time up to 4 weeks after preoperative treatment
analysis of TGF-β
and RNA extraction
Measured: one time up to 4 weeks after preoperative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Aug 2021
- Primary completion1 Oct 2023
- Study completion30 Nov 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 KeloidStudies 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
- 58 patients will be allocated in the experimental and control groups: sham (N = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and experimental group with active PBM combined with IAC (N = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4 W, 24J per point on 10 linear points, total 240J).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Raquel AM Ferrari, Phd, Principal investigator, Nove de Julho University (Uninove)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824612
- Sponsor's protocol ID
- Keloid
- Status last verified
- Aug 2024
- First submitted
- 24 Mar 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pires JA, Bragato EF, Momolli M, Guerra MB, Neves LM, de Oliveira Bruscagnin MA, Ratto Tempestini Horliana AC, Porta Santos Fernandes K, Kalil Bussadori S, Agnelli Mesquita Ferrari R. Effect of the combination of photobiomodulation therapy and the intralesional administration of corticoid in the preoperative and postoperative periods of keloid surgery: A randomized, controlled, double-blind trial protocol study. PLoS One. 2022 Feb 15;17(2):e0263453. doi: 10.1371/journal.pone.0263453. eCollection 2022.
PubMed 35167583
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combination of Photobiomodulation Therapy and the Intralesional Administration of Corticoid in the Preoperative and Postoperative Periods of Keloid Surgery: a Randomized, Controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT04824612
- Acronym / sponsor ID
- Keloid
- Keywords
- keloid, photobiomodulation, corticoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 1 Apr 2021 (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.
A randomized, controlled, double-blind, clinical trial will be conducted to study the evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery.
Detailed description
Keloid scars are characterized by the excessive proliferation of fibroblasts and an imbalance between the production and degradation of collagen, leading to its buildup in the dermis. Although the genesis of this condition is not yet fully clarified, keloids are known to have a genetic component and are related to an increase in the expression of transforming growth factor beta (TGF-β). There is no "gold standard" treatment and recurrence is frequent. Therefore, novel treatment options are needed. In vitro studies have demonstrated that photobiomodulation (PBM) reduces the multiplication velocity and quantity of fibroblasts as well as the expression of TGF-β. This is a low-cost, noninvasive therapy with no side effects that has proved to be a good tool to complement the most established treatment. Therefore, the purpose of this study is to evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery. A randomized, controlled, double-blind, clinical trial will be conducted involving two groups: 1) Sham (N = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and 2) active PBM combined with IAC (N = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). The patients will answer two questionnaires: one for the assessment of quality of life (Qualifibro-UNIFESP) and one for the assessment of satisfaction with the scar (PSAQ). The team of plastic surgeons will answer the Vancouver Scar Scale (VSS). All questionnaires will be administered one, three, six, and twelve months postoperatively. The keloids will be molded in silicone prior to the onset of treatment and prior to excision to assess pre-treatment and post-treatment size. The same will be performed for the remaining scar at one, three, six, and twelve months postoperatively. The removed keloid will be sent for histopathological analysis for the determination of the quantity of fibroblasts, the organization and distribution of collagen (picrosirius staining), and the expression of TGF-β. All data will be submitted to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 58 patients will be allocated in the experimental and control groups: sham (N = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and experimental group with active PBM combined with IAC (N = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4 W, 24J per point on 10 linear points, total 240J).
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Drug: Triamcinolone Hexacetonide, Device: Sham LEDintralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide (Triancil®, Apsen Farmacêutica S.A.) - two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies. Sham PBM in the preoperative and postoperative periods of keloid removal surgery: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. |
| Experimental Group | Experimental | Device: Photobiomodulation with blue led, Drug: Triamcinolone HexacetonideTranscutaneous PBM will be performed on the keloid in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). Frequency: Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. Intralesional administration of corticoid (IAC): intralesional injection of 20 mg/ml triamcinolone hexacetonide: two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 65 years;
- Fitzpatrick skin phototype I-VI;
- Keloid with no type of previous treatment;
- Recurring keloid after surgical excision;
- Recurring keloid after use of other therapies and at least three months without treatment.
Key exclusion criteria (6 listed)
- Keloid in treatment;
- Pregnant and lactating women;
- Keloid with primary synthesis of the skin and no possibility of excision.
- Contraindications for undergoing surgery (e.g.: coagulopathies, diabetes myellitus, drug allergies);
- Contraindications for the use of corticosteroids;
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 |
|---|---|---|
| Photobiomodulation with blue ledPreoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J). | Device | Experimental Group |
| Triamcinolone Hexacetonideintralesional injection of 20 mg/ml. two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies. | Drug | Experimental Group, Sham Group |
| Sham LEDA blue LED without power and biologic effect. | Device | Sham Group |
Primary outcome
scar assessment by specialists (change in the scar of is being evaluated)
Time frame: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
Blinded, calibrated, certified plastic surgeons will answer the Vancouver Scar Scale (VSS), which was translated into Portuguese by Santos et al. This scale focuses on four parameters: scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 points. The VSS set a precedent for the systematic evaluation of scars, taking a semiquantitative approach to organize a collection of subjective assessments.
Quality of Life of the patients (change in quality of life is being evaluated)
Time frame: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
The Quality of Life of Patients with Keloid and Hypertrophic Scarring questionnaire. The participants will answer the questionnaires. Answer choices are on a Likert Scale with the following choices: -5 (totally inaccurate), -3 (inaccurate), -1 (somewhat inaccurate), 1 (fairly accurate), 3 (accurate), 5 (completely accurate).
patient satisfaction with the scar (change in the quality of scar is being evaluated)
Time frame: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.
The participants will also answer Part II (classification of satisfaction) of the Patient Scar Assessment Questionnaire (PSAQ) Participant answer: Very satisfied, Satisfied Dissatisfied and Very Dissatisfied.
4 secondary outcomes
keloid and remaining scar size
Time frame: These procedures will be performed in baseline (preoperatively) as well as one, three, six, and twelve months postoperatively.
Fibroblasts analysis
Time frame: one time up to 4 weeks after preoperative treatment
analysis of collagen
Time frame: one time up to 4 weeks after preoperative treatment
analysis of TGF-β
Time frame: one time up to 4 weeks after preoperative treatment
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 22 Aug 2024.
- Derived from this study: PubMed 35167583Pires JA, Bragato EF, Momolli M, Guerra MB, Neves LM, de Oliveira Bruscagnin MA, Ratto Tempestini Horliana AC, Porta Santos Fernandes K, Kalil Bussadori S, Agnelli Mesquita Ferrari R. Effect of the combination of photobiomodulation therapy and the intralesional administration of corticoid in the preoperative and postoperative periods of keloid surgery: A randomized, controlled, double-blind trial protocol study. PLoS One. 2022 Feb 15;17(2):e0263453. doi: 10.1371/journal.pone.0263453. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Keloid
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
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.
Raquel AM Ferrari, Phd principal investigator
Nove de Julho University (Uninove)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation with blue led and Triamcinolone Hexacetonide in people with Keloid and Cicatrix, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 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 22 Aug 2024. 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 Brazil. 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?
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?
scar assessment by specialists (change in the scar of is being evaluated) (time frame: Baseline (after the clinical evaluation prior to the intervention) as well as one, three, six, and twelve months postoperatively.). The study lists 3 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 NCT04824612, 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 22 Aug 2024.