Atopic DermatitisGERONIMONCT07295678
URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis
A study testing Treatment period with dermocorticoid alone, Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid and Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid in people with Atopic Dermatitis, run by CEN Biotech at 2 sites in Poland.
Trial summary
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Treatment period with dermocorticoid alone, Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid and Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesPoland
- Study dates
- 5 Jan 2026to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject.
- Aged 18 or more.
- With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).
- Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.
- Having given her/his informed, written consent,
- Cooperative, fully informed of the treatment procedures, and aware of the importance and schedule of follow-up visits, ensuring expected full adherence to the study protocol.
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- Psychologically capable of understanding the study information and providing informed consent.
- Affiliated to a health social security system.
- Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end and must have a negative urine pregnancy test before the first treatment.
Who cannot join
- Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
- Subject unable to understand the information provided - including study procedures - due to linguistic or psychiatric reasons, and therefore unable to give written informed consent or to complete the study diary as required.
- Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.
- Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.
- Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study.
- Subject with a known contraindication to topical corticosteroids, such as hypersensitivity to desonide, betamethasone, or any component of the prescribed corticosteroid formulations.
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- Subject with broken or ulcerated skin, acne, rosacea (including perioral dermatitis), any untreated or active skin infection (viral, bacterial, or fungal), or skin thinning at the application sites.
- Subject with a skin disease, abnormality, or dermatological condition in the study area that may interfere with study assessments.
- Subject with acute, chronic, or progressive disease, or relevant medical history, considered by the investigator to be hazardous for the subject, incompatible with the study, or likely to interfere with study assessments.
- Any systemic treatment, including oral corticosteroids, that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit, ongoing, or planned to start during the study.
- Any topical treatment on the tested area that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Eurofins Dermscan Poland
Gdansk
Joanna PAŁUBICKA, +48 58 732 02 99, JPA@dermscan.pl
Justyna Sowińska, MD, +48 58 732 02 90, jso@dermscan.pl
Private Practice
Malbork
Ewa Karamon, MD, +48 603 977 986, ewaczek20@wp.pl
Ewa Karamon, MD
About this study
Official title: Open-label Clinical Investigation to Evaluate the Performance and Safety of Medical Device "Urgo Filmocream Eczema" in Association With Dermocorticoids on Atopic Dermatitis Lesions
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. The main questions the study seeks to answer are:
- Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment?
- How do eczema lesions treated with topical corticosteroids alone progress and heal compared to those treated with topical corticosteroids plus URGO FilmoCream Eczema? To investigate this, patients with at least two similar eczema lesions are enrolled. One lesion is treated with topical corticosteroids alone, while the other is treated with topical corticosteroids plus URGO FilmoCream Eczema.
The progression of both lesions is monitored throughout treatment, until healing, and for 28 days after the last application of topical corticosteroids.
Read the detailed description
This study has two parts.
- Treatment phase (up to 30 days):
- For the lesions treated with the combination of both products, URGO FilmoCream Eczema is applied at least twice a day, in the morning and evening. In the evening, it is applied after topical corticosteroid (Desonide 0.1% or, if needed, betamethasone 0.05%).
- For the lesion treated with topical corticosteroid only: treatment starts with Desonide 0.1% and may switch to betamethasone 0.05% if needed.
This part lasts until the skin is fully healed.
- Conditions
- Atopic Dermatitis
- Being tested
- Treatment period with dermocorticoid alone, Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid, Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid, Follow-up period after dermocorticoid treatment alone
- Keywords
- eczema lesions, adjuvant treatment to dermocorticoids, URGO FilmoCream Eczema
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment period with dermocorticoid aloneDrug
Until lesion resolution, for a maximum of 30 consecutive days Treatment with dermocorticoids - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.
Treatment period with combination of URGO FilmoCream Eczema and dermocorticoidCombination product
Until lesion resolution, for a maximum of 30 consecutive days URGO FilmoCream Eczema is applied at least twice daily (morning and evening) in a thin layer over the entire surface of the selected lesion, extending 1 cm beyond the edges, and left to dry for about 30 seconds to form a protective film. Reapplication is allowed if the film is disturbed (e.g., due to water exposure), with a maximum of 20 pump pressures per day. In the evening, it is applied after the dermocorticoid - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.
Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoidCombination product
During the 28-day follow-up period, in case of relapse, URGO FilmoCream Eczema is reapplied twice daily (morning and evening). If there is no improvement or worsening, the combined treatment must be reinitiated under the same conditions as during the treatment period.
Follow-up period after dermocorticoid treatment aloneDrug
During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary.
| Study group | Role | What they receive |
|---|---|---|
| URGO FilmoCream Eczema plus dermocorticoid | Experimental | During the treatment period, URGO FilmoCream Eczema is used alone in the morning and in combination with a topical corticosteroid in the evening.
During the follow-up phase, it is applied only in case of relapse, twice daily. If the lesion does not improve or worsens, it must be combined with a dermocorticoid in the evening, as during the treatment period. Receives: Combination Product: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid; Combination Product: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid |
| Dermocorticoid alone | Active comparator | During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse. Receives: Drug: Treatment period with dermocorticoid alone; Drug: Follow-up period after dermocorticoid treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in local SCORAD Index at end of treatment
The local SCORAD Index includes the intensity part of SCORAD (SCORing Atopic Dermatitis) index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
The variations from baseline in the Local SCORAD Index are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Measured: up to 30 days
Change from baseline in local SCORAD Index at 3 days
The variations from baseline at 3 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
Measured: 3 days
Change from baseline in local SCORAD Index at 7 days
The variations from baseline at 7 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
Measured: 7 days
Secondary outcomes (8)
Change from baseline in pruritus severity at 3 days
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch.
The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Measured: 3 days
Change from baseline in pruritus severity at 7 days
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch.
The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Measured: 7 days
Change from baseline in pruritus severity at end of treatment
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch.
The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Measured: up to 30 days
Time to complete lesion resolution
Complete resolution is subjectively assessed by the investigator. The time to complete resolution is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test.
Measured: 30 days
Dermocorticoid use during the treatment period
The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between lesions treated with combination therapy and those treated with dermocorticoid alone.
Measured: 30 days
Relapse rate after initial treatment
Proportions of lesions that relapse after having achieved resolution during the treatment period are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Measured: 28 days
Time to the first relapse after initial treatment
The time to the first relapse after initial treatment is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test
Measured: 28 days
Dermocorticoid use in relapsed lesions
The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between relapsed lesions initially treated with the combination therapy and those initially treated with dermocorticoid alone.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- In this intra-individual randomized design, each subject will have two comparable AD lesions, each randomized to receive either URGO FilmoCream Eczema + Desonide 0.1% cream or Desonide 0.1% cream alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan, URGO Recherche, Innovation et Développement
- Responsible party
- Sponsor
- Investigators
- Ewa Karamon, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295678
- Sponsor's protocol ID
- 22E4474
- Acronym
- GERONIMO
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is not anonymized. To comply with European regulations, patients are informed that no sharing of IPD is planned in order to protect their personal data. Only aggregated data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Clinical Investigation to Evaluate the Performance and Safety of Medical Device "Urgo Filmocream Eczema" in Association With Dermocorticoids on Atopic Dermatitis Lesions
- ClinicalTrials.gov ID
- NCT07295678
- Acronym / sponsor ID
- GERONIMO / 22E4474
- Conditions
- Atopic Dermatitis
- Keywords
- eczema lesions, adjuvant treatment to dermocorticoids, URGO FilmoCream Eczema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan, URGO Recherche, Innovation et Développement
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 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.
The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. The main questions the study seeks to answer are:
- Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment?
- How do eczema lesions treated with topical corticosteroids alone progress and heal compared to those treated with topical corticosteroids plus URGO FilmoCream Eczema? To investigate this, patients with at least two similar eczema lesions are enrolled. One lesion is treated with topical corticosteroids alone, while the other is treated with topical corticosteroids plus URGO FilmoCream Eczema.
The progression of both lesions is monitored throughout treatment, until healing, and for 28 days after the last application of topical corticosteroids.
Detailed description
This study has two parts.
- Treatment phase (up to 30 days):
- For the lesions treated with the combination of both products, URGO FilmoCream Eczema is applied at least twice a day, in the morning and evening. In the evening, it is applied after topical corticosteroid (Desonide 0.1% or, if needed, betamethasone 0.05%).
- For the lesion treated with topical corticosteroid only: treatment starts with Desonide 0.1% and may switch to betamethasone 0.05% if needed.
This part lasts until the skin is fully healed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this intra-individual randomized design, each subject will have two comparable AD lesions, each randomized to receive either URGO FilmoCream Eczema + Desonide 0.1% cream or Desonide 0.1% cream alone.
| Arm | Type | Receives |
|---|---|---|
| URGO FilmoCream Eczema plus dermocorticoid | Experimental | Combination Product: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid, Combination Product: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoidDuring the treatment period, URGO FilmoCream Eczema is used alone in the morning and in combination with a topical corticosteroid in the evening. During the follow-up phase, it is applied only in case of relapse, twice daily. If the lesion does not improve or worsens, it must be combined with a dermocorticoid in the evening, as during the treatment period. |
| Dermocorticoid alone | Active comparator | Drug: Treatment period with dermocorticoid alone, Drug: Follow-up period after dermocorticoid treatment aloneDuring the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject.
- Aged 18 or more.
- With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).
- Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.
- Having given her/his informed, written consent,
Key exclusion criteria (11 listed)
- Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.
- Subject unable to understand the information provided - including study procedures - due to linguistic or psychiatric reasons, and therefore unable to give written informed consent or to complete the study diary as required.
- Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.
- Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.
- Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the 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 |
|---|---|---|
| Treatment period with dermocorticoid aloneUntil lesion resolution, for a maximum of 30 consecutive days Treatment with dermocorticoids - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required. | Drug | Dermocorticoid alone |
| Treatment period with combination of URGO FilmoCream Eczema and dermocorticoidUntil lesion resolution, for a maximum of 30 consecutive days URGO FilmoCream Eczema is applied at least twice daily (morning and evening) in a thin layer over the entire surface of the selected lesion, extending 1 cm beyond the edges, and left to dry for about 30 seconds to form a protective film. Reapplication is allowed if the film is disturbed (e.g., due to water exposure), with a maximum of 20 pump pressures per day. In the evening, it is applied after the dermocorticoid - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required. | Combination product | URGO FilmoCream Eczema plus dermocorticoid |
| Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoidDuring the 28-day follow-up period, in case of relapse, URGO FilmoCream Eczema is reapplied twice daily (morning and evening). If there is no improvement or worsening, the combined treatment must be reinitiated under the same conditions as during the treatment period. | Combination product | URGO FilmoCream Eczema plus dermocorticoid |
| Follow-up period after dermocorticoid treatment aloneDuring the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary. | Drug | Dermocorticoid alone |
Primary outcome
Change from baseline in local SCORAD Index at end of treatment
Time frame: up to 30 days
The local SCORAD Index includes the intensity part of SCORAD (SCORing Atopic Dermatitis) index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation. The variations from baseline in the Local SCORAD Index are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Change from baseline in local SCORAD Index at 3 days
Time frame: 3 days
The variations from baseline at 3 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
Change from baseline in local SCORAD Index at 7 days
Time frame: 7 days
The variations from baseline at 7 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
8 secondary outcomes
Change from baseline in pruritus severity at 3 days
Time frame: 3 days
Change from baseline in pruritus severity at 7 days
Time frame: 7 days
Change from baseline in pruritus severity at end of treatment
Time frame: up to 30 days
Time to complete lesion resolution
Time frame: 30 days
Dermocorticoid use during the treatment period
Time frame: 30 days
Relapse rate after initial treatment
Time frame: 28 days
Time to the first relapse after initial treatment
Time frame: 28 days
Dermocorticoid use in relapsed lesions
Time frame: 28 days
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 26 Dec 2025.
- Individual participant dataSharing planned: No. Patient data is not anonymized. To comply with European regulations, patients are informed that no sharing of IPD is planned in order to protect their personal data. Only aggregated data can be shared.
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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.
Ewa Karamon principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment period with dermocorticoid alone, Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid and Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid in people with Atopic Dermatitis, run by CEN Biotech at 2 sites in Poland.
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 11 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: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
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?
Contact Christelle FOUCHER (+33380447049, c.foucher@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in local SCORAD Index at end of treatment (time frame: up to 30 days). 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?
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 26 Dec 2025.