Androgenetic AlopeciaPhase 2/3NCT03742518
A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia
A Phase 2/3 study testing Topical SM04554 0.15% solution and Topical SM04554 0.25% solution in people with Androgenetic Alopecia, run by Biosplice Therapeutics, Inc. at 14 sites in Turkey (Türkiye).
Trial summary
This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Topical SM04554 0.15% solution and Topical SM04554 0.25% solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 14 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 31 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Being a Turkish citizen
- Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 3V or 4
- Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
- Willing and able to attend all study visits
- Willing to maintain the same hair style and length as at the study start for the duration of the study
- Willing to not use semi-permanent hair products (e.g., color, texturizers, relaxers) for the duration of the study; daily styling products (e.g., hair gel, mousse, styling spray) will be allowed on non-study visit days
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- Willing to use mild non-medicated shampoo and conditioner for the duration of the study
- Able to read and understand Turkish
- Ability to comprehend and willing to sign an informed consent form
Who cannot join
- Males who are sexually active, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use condom or whose partner is not using a highly effective method of birth control that includes double barrier, intrauterine device, or hormonal contraceptive combined with single barrier, or abstinence during the study treatment period until 90 days post last dose of study medication
- Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- History of surgical correction (e.g., hair transplantation, scalp reduction) of hair loss on the scalp
- Previous exposure to SM04554
- Use of any products (e.g., finasteride, minoxidil, platelet rich plasma, biotin) or devices (e.g., laser light therapy) purported to promote scalp hair growth within 24 weeks prior to the start of the study
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- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 12 weeks prior to the start of the study
- Use of medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within 12 weeks prior to the start of the study
- Current use of an occlusive wig, hair extensions, or hair weaves
- History of hypersensitivity or allergies to any ingredient of the study medication
- Participation in any other investigational drug or medical device trial, which includes or included administration of an investigational study medication or medical device, within 30 days or 5 half-lives of the investigational agent, whichever is longer, prior to the start of the study
- Use of semi-permanent hair products (e.g., color, texturizers, relaxers) within 30 days prior to the start of the study
- Use of medicated shampoo or conditioner (medicated shampoo and conditioner refers to any prescription shampoo or conditioner as well as any over-the-counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth) within 30 days prior to the start of the study
- Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
- Subjects employed by Samumed, LLC or Samumed Turkey, or any of its affiliates or development partners (i.e., an employee, temporary contract worker, or designee) responsible for the conduct of the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Turkey (Türkiye)14 sites
Research Site
Ankara, 06100
Research Site
Ankara, 06110
Research Site
Ankara, 06680
Research Site
Bursa, 16059
Research Site
Denizli, 20070
Research Site
Istanbul, 34098
Research Site
Istanbul, 34668
Research Site
Izmir, 35180
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Research Site
Mersin, 33343
Research Site
Samsun, 55139
Research Site 1
Trabzon, 61080
Research Site 2
Trabzon, 61080
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 0.15% & 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia
This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.
Read the detailed description
This study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in Turkey of 2 different strengths of topical SM04554 solution applied QD to the scalp of male androgenetic alopecia (AGA) subjects - otherwise known as male pattern baldness.
Following a screening period of up to 2 weeks, subjects participated in the study for 54 weeks (48 weeks of treatment and 6 weeks of follow-up). Subjects were randomized into 1 of 3 groups in a 2:2:1 randomization scheme: SM04554 0.15% solution, SM04554 0.25% solution, and vehicle placebo.
Primary outcome of this study was change in absolute hair count as assessed by phototrichogram, a non-invasive and reproducible method to measure changes in hair.
- Conditions
- Androgenetic Alopecia
- Being tested
- Topical SM04554 0.15% solution, Topical SM04554 0.25% solution, Topical vehicle solution
- Keywords
- male pattern baldness, SM04554, AGA
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SM04554 0.15% solutionDrug
Study medication application will be performed by the individual subject at approximately the same time each day.
Topical SM04554 0.25% solutionDrug
Study medication application will be performed by the individual subject at approximately the same time each day.
Topical vehicle solutionDrug
Vehicle solution application will be performed by the individual subject at approximately the same time each day.
| Study group | Role | What they receive |
|---|---|---|
| Topical SM04554 0.15% solution | Experimental | Topical SM04554 0.15% solution, once daily for up to 48 weeks Receives: Drug: Topical SM04554 0.15% solution |
| Topical SM04554 0.25% solution | Experimental | Topical SM04554 0.25% solution, once daily for up to 48 weeks Receives: Drug: Topical SM04554 0.25% solution |
| Vehicle | Placebo comparator | Topical vehicle solution, once daily for up to 48 weeks Receives: Drug: Topical vehicle solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Non-vellus Hair Count in Target Area
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Week 48
Secondary outcomes (10)
Absolute Non-vellus Hair Count in Target Area
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Weeks 12, 24, and 36
Absolute Vellus Hair Count in Target Area
Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Weeks 12, 24, 36 and 48
Absolute Total Hair Count in Target Area
Total hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Weeks 12, 24, 36 and 48
Change From Baseline in Non-vellus Hair Count in Target Area
Change from baseline in non-vellus hair count in target area by PTG analysis.
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Vellus Hair Count in Target Area
Change from baseline in vellus hair count in target area by PTG analysis.
Vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Total Hair Count in Target Area
Change from baseline in total hair count in target area by PTG analysis.
Vellus and non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area
Change from baseline in average non-vellus hair shaft thickness in target area by PTG analysis.
Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
Measured: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Average Non-vellus Hair Density in Target Area
Change from baseline in average non-vellus hair density (cumulative non-vellus hair shaft thickness) in target area by PTG analysis.
Non-vellus hair shaft thickness was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
For this outcome, the cumulative non-vellus hair shaft thickness in the measurement area was summarized.
Measured: Baseline, and Weeks 12, 24, 36 and 48
Improvement in Subject Assessment of Hair Growth
Subjects will complete a questionnaire for hair growth while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). Improvement is defined as +1, +2, and +3: Much Better.
Measured: Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Change From Baseline in Subject Assessment of Hair Satisfaction
Subjects will complete a questionnaire for hair satisfaction while referencing the global scalp photograph taken at the visit as compared to their baseline global scalp photograph. The scale for the questionnaire ranges from -3 to +3 (-3 indicates the worst outcome and +3 indicates the best outcome). The change from baseline is the difference between the baseline and follow-up response.
Measured: Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Androgenetic AlopeciaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Yazici, M.D., Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742518
- Sponsor's protocol ID
- SM04554-AGA-05
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2018
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 0.15% & 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT03742518
- Acronym / sponsor ID
- SM04554-AGA-05
- Conditions
- Androgenetic Alopecia
- Keywords
- male pattern baldness, SM04554, AGA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 1 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.
Detailed description
This study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in Turkey of 2 different strengths of topical SM04554 solution applied QD to the scalp of male androgenetic alopecia (AGA) subjects - otherwise known as male pattern baldness.
Following a screening period of up to 2 weeks, subjects participated in the study for 54 weeks (48 weeks of treatment and 6 weeks of follow-up). Subjects were randomized into 1 of 3 groups in a 2:2:1 randomization scheme: SM04554 0.15% solution, SM04554 0.25% solution, and vehicle placebo.
Primary outcome of this study was change in absolute hair count as assessed by phototrichogram, a non-invasive and reproducible method to measure changes in hair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical SM04554 0.15% solution | Experimental | Drug: Topical SM04554 0.15% solutionTopical SM04554 0.15% solution, once daily for up to 48 weeks |
| Topical SM04554 0.25% solution | Experimental | Drug: Topical SM04554 0.25% solutionTopical SM04554 0.25% solution, once daily for up to 48 weeks |
| Vehicle | Placebo comparator | Drug: Topical vehicle solutionTopical vehicle solution, once daily for up to 48 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being a Turkish citizen
- Clinical diagnosis of AGA with Norwood-Hamilton Classification score of 3V or 4
- Willing to inform females, with whom they may interact, that they are using a topical investigational product and direct contact should be avoided as potential harm to a fetus is unknown
- Willing and able to attend all study visits
- Willing to maintain the same hair style and length as at the study start for the duration of the study
Key exclusion criteria (15 listed)
- Males who are sexually active, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use condom or whose partner is not using a highly effective method of birth control that includes double barrier, intrauterine device, or hormonal contraceptive combined with single barrier, or abstinence during the study treatment period until 90 days post last dose of study medication
- Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- History of surgical correction (e.g., hair transplantation, scalp reduction) of hair loss on the scalp
- Previous exposure to SM04554
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 |
|---|---|---|
| Topical SM04554 0.15% solutionStudy medication application will be performed by the individual subject at approximately the same time each day. | Drug | Topical SM04554 0.15% solution |
| Topical SM04554 0.25% solutionStudy medication application will be performed by the individual subject at approximately the same time each day. | Drug | Topical SM04554 0.25% solution |
| Topical vehicle solutionVehicle solution application will be performed by the individual subject at approximately the same time each day. | Drug | Vehicle |
Primary outcome
Absolute Non-vellus Hair Count in Target Area
Time frame: Week 48
Non-vellus hair count was determined by phototrichogram. Standardized phototrichogram images of the treatment area were taken on Visit Day 1 (pre-treatment), as well as at visits occuring at Weeks 12, 24, 36, and 48. A rectangular area of the subject's hair with dimensions 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length prior to performing the phototrichogram. Virtual tattoo technology was used to anchor the phototrichogram. Images were uploaded from sites to the blinded vendor where assessment of the phototrichogram took place.
10 secondary outcomes
Absolute Non-vellus Hair Count in Target Area
Time frame: Weeks 12, 24, and 36
Absolute Vellus Hair Count in Target Area
Time frame: Weeks 12, 24, 36 and 48
Absolute Total Hair Count in Target Area
Time frame: Weeks 12, 24, 36 and 48
Change From Baseline in Non-vellus Hair Count in Target Area
Time frame: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Vellus Hair Count in Target Area
Time frame: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Total Hair Count in Target Area
Time frame: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Average Non-vellus Hair Shaft Thickness in Target Area
Time frame: Baseline, and Weeks 12, 24, 36 and 48
Change From Baseline in Average Non-vellus Hair Density in Target Area
Time frame: Baseline, and Weeks 12, 24, 36 and 48
Improvement in Subject Assessment of Hair Growth
Time frame: Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Change From Baseline in Subject Assessment of Hair Satisfaction
Time frame: Baseline, and Weeks 6, 12, 18, 24, 30, 36, 42 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
Yusuf Yazici, M.D. study director
Biosplice Therapeutics, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical SM04554 0.15% solution and Topical SM04554 0.25% solution in people with Androgenetic Alopecia, run by Biosplice Therapeutics, Inc. at 14 sites in Turkey (Türkiye).
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 9 inclusion and 15 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Turkey (Türkiye). 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2026). 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?
Absolute Non-vellus Hair Count in Target Area (time frame: Week 48). 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 1 Oct 2026.