Dermatitis, AtopicNCT06553417
Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis
A study testing Aqua posae and microresyl and Urea 10% in people with Dermatitis, Atopic, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is: " To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Aqua posae and microresyl and Urea 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 29 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years
- AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
- Patients with mild-moderate AD according to the SCORAD index.
- Patients who have AD lesions on the hands and/or feet.
- Patients with good general condition.
- Patients are willing to participate in the study and sign the informed consent.
Who cannot join
- Pregnant and lactating patients.
- Patients with a history of allergies to ingredients contained in moisturizers
- Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
- Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
- Patients receiving topical and/or systemic antibiotic therapy
- Patients receiving systemic antihistamine therapy (patients who require antihistamines during the study will be recorded on the observation sheet)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerability of an Emollient 'Plus' Compared to Urea 10% in Patients With Mild-moderate Atopic Dermatitis
The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:
" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.
- Conditions
- Dermatitis, Atopic
- Being tested
- Aqua posae and microresyl, Urea 10%
- Keywords
- atopic dermatitis, skin barrier, moisturizer, bacterial lysate, clinical efficacy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua posae and microresylOther
- This intervention involves the use of two topical products:
- Aqua posae - a moisturizing agent
- Microresyl - an active ingredient with potential therapeutic effects
- Subjects in Group A will be instructed to apply these two products (aqua posae and microresyl) twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin.
The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.
Urea 10%Other
Intervention 2: Urea 10%
- This intervention involves the use of a 10% urea-based topical moisturizing product.
- Subjects in Group B will be instructed to apply the 10% urea moisturizer twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin.
The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| Aqua posae + microresyl | Experimental | • Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl. Receives: Other: Aqua posae and microresyl |
| 10% Urea | Active comparator | • Participants in this arm will receive the moisturizer formulation containing 10% urea. Receives: Other: Urea 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD (Scoring Atopic Dermatitis)
- The SCORAD is a composite score that evaluates the extent and severity of atopic dermatitis.
- The SCORAD scale ranges from 0 to 103, with higher scores indicating more severe disease. The ranges of the SCORAD (0-25 for 'mild' disease, and 25-50 for 'moderate' disease, >50 for severe disease)
Measured: Through study completion, 12 week
PVAS (Pruritus Visual Analog Scale)
- The PVAS is a 100 mm visual analog scale that assesses the severity of pruritus (itching) experienced by the patient.
- The PVAS ranges from 0 (no itch) to 100 (worst imaginable itch).
Measured: Through study completion, 12 week
EASI (Eczema Area and Severity Index)
- The EASI is a tool that measures the extent and severity of atopic dermatitis lesions.
- The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe
Measured: Through study completion, 12 week
DLQI (Dermatology Life Quality Index)
- The DLQI is a questionnaire that assesses the impact of skin diseases on a patient's quality of life.
- The DLQI score ranges from 0 to 30, with higher scores indicating a greater impairment of quality of life.
Measured: Through study completion, 12 week
Secondary outcomes (3)
Transepidermal Water Loss (TEWL)
- TEWL is a measure of the barrier function of the skin, with higher values indicating a more compromised skin barrier.
- TEWL is typically measured in g/m^2/h.
Measured: Through study completion, 12 week
Skin Hydration
- Skin hydration is a measure of the moisture content of the skin, with higher values indicating more hydrated skin.
- Skin hydration is typically measured using corneometry, with the values reported in arbitrary units (a.u.).
Measured: Through study completion, 12 week
Skin pH
- Skin pH is a measure of the acidity of the skin surface, with normal skin having a slightly acidic pH around 5.5.
- Skin pH is measured on a scale from 0 to 14, with lower values indicating more acidic skin.
Measured: Through study completion, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jun 2023
- Primary completion29 Sep 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- L'Oreal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553417
- Sponsor's protocol ID
- 2141/112/2/V/2023
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
PubMed 22310478Zelenkova H, Kerob D, Salah S, Demessant-Flavigny AL. Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:27-34. doi: 10.1111/jdv.18947. Epub 2023 Apr 24.
PubMed 37092256Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, Gieler U, Girolomoni G, Lau S, Muraro A, Czarnecka-Operacz M, Schafer T, Schmid-Grendelmeier P, Simon D, Szalai Z, Szepietowski JC, Taieb A, Torrelo A, Werfel T, Ring J; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients' Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS). Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018 May;32(5):657-682. doi: 10.1111/jdv.14891.
PubMed 29676534Ch'ng CC. Rebalancing of the skin microbiome with an emollient 'plus' for effective management of atopic dermatitis: A mini review. Med J Malaysia. 2024 Mar;79(2):203-205.
PubMed 38553927Gueniche A, Knaudt B, Schuck E, Volz T, Bastien P, Martin R, Rocken M, Breton L, Biedermann T. Effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study. Br J Dermatol. 2008 Dec;159(6):1357-63. doi: 10.1111/j.1365-2133.2008.08836.x. Epub 2008 Sep 15.
PubMed 18795916Wollenberg A, Kinberger M, Arents B, Aszodi N, Barbarot S, Bieber T, Brough HA, Pinton PC, Christen-Zaech S, Deleuran M, Dittmann M, Fosse N, Gaspar K, Gerbens LAA, Gieler U, Girolomoni G, Gregoriou S, Mortz CG, Nast A, Nygaard U, Rehbinder EM, Ring J, Rossi M, Roxburgh C, Serra-Baldrich E, Simon D, Szalai ZZ, Szepietowski JC, Torrelo A, Werfel T, Flohr C. First update of the living European guideline (EuroGuiDerm) on atopic eczema. J Eur Acad Dermatol Venereol. 2023 Nov;37(11):e1283-e1287. doi: 10.1111/jdv.19269. Epub 2023 Jul 17. No abstract available.
PubMed 37328919Seite S, Zelenkova H, Martin R. Clinical efficacy of emollients in atopic dermatitis patients - relationship with the skin microbiota modification. Clin Cosmet Investig Dermatol. 2017 Jan 12;10:25-33. doi: 10.2147/CCID.S121910. eCollection 2017.
PubMed 28138262Magnolo N, Jaenicke T, Tsianakas A, Czech W, Thaci D, Pinter A, Kerob D, Salah S, Luger TA. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:18-26. doi: 10.1111/jdv.18949. Epub 2023 Apr 24.
PubMed 37092275
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of an Emollient 'Plus' Compared to Urea 10% in Patients With Mild-moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06553417
- Acronym / sponsor ID
- 2141/112/2/V/2023
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, skin barrier, moisturizer, bacterial lysate, clinical efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- L'Oreal
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 14 Aug 2024 (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 trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:
" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqua posae + microresyl | Experimental | Other: Aqua posae and microresyl• Participants in this arm will receive the moisturizer formulation containing aqua posae and microresyl. |
| 10% Urea | Active comparator | Other: Urea 10%• Participants in this arm will receive the moisturizer formulation containing 10% urea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥18 years
- AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
- Patients with mild-moderate AD according to the SCORAD index.
- Patients who have AD lesions on the hands and/or feet.
- Patients with good general condition.
Key exclusion criteria (6 listed)
- Pregnant and lactating patients.
- Patients with a history of allergies to ingredients contained in moisturizers
- Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
- Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
- Patients receiving topical and/or systemic antibiotic therapy
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 |
|---|---|---|
| Aqua posae and microresyl* This intervention involves the use of two topical products: * Aqua posae - a moisturizing agent * Microresyl - an active ingredient with potential therapeutic effects * Subjects in Group A will be instructed to apply these two products (aqua posae and microresyl) twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin. The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects. | Other | Aqua posae + microresyl |
| Urea 10%Intervention 2: Urea 10% * This intervention involves the use of a 10% urea-based topical moisturizing product. * Subjects in Group B will be instructed to apply the 10% urea moisturizer twice daily to the upper and lower limbs, including both lesional and non-lesional areas of the skin. The use of these interventions will be evaluated over a 12-week period, with assessments of Transepidermal Water Loss (TEWL), skin hydration, skin pH, index scoring of atopic dermatitis (SCORAD), erythema area severity index (EASI), pruritus visual analogue scale (PVAS), quality of life (DLQI), and any adverse effects. | Other | 10% Urea |
Primary outcome
SCORAD (Scoring Atopic Dermatitis)
Time frame: Through study completion, 12 week
* The SCORAD is a composite score that evaluates the extent and severity of atopic dermatitis. * The SCORAD scale ranges from 0 to 103, with higher scores indicating more severe disease. The ranges of the SCORAD (0-25 for 'mild' disease, and 25-50 for 'moderate' disease, >50 for severe disease)
PVAS (Pruritus Visual Analog Scale)
Time frame: Through study completion, 12 week
* The PVAS is a 100 mm visual analog scale that assesses the severity of pruritus (itching) experienced by the patient. * The PVAS ranges from 0 (no itch) to 100 (worst imaginable itch).
EASI (Eczema Area and Severity Index)
Time frame: Through study completion, 12 week
* The EASI is a tool that measures the extent and severity of atopic dermatitis lesions. * The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe
DLQI (Dermatology Life Quality Index)
Time frame: Through study completion, 12 week
* The DLQI is a questionnaire that assesses the impact of skin diseases on a patient's quality of life. * The DLQI score ranges from 0 to 30, with higher scores indicating a greater impairment of quality of life.
3 secondary outcomes
Transepidermal Water Loss (TEWL)
Time frame: Through study completion, 12 week
Skin Hydration
Time frame: Through study completion, 12 week
Skin pH
Time frame: Through study completion, 12 week
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 14 Aug 2024.
- Background: PubMed 22310478Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
- Background: PubMed 37092256Zelenkova H, Kerob D, Salah S, Demessant-Flavigny AL. Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:27-34. doi: 10.1111/jdv.18947. Epub 2023 Apr 24.
- Background: PubMed 29676534Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, Gieler U, Girolomoni G, Lau S, Muraro A, Czarnecka-Operacz M, Schafer T, Schmid-Grendelmeier P, Simon D, Szalai Z, Szepietowski JC, Taieb A, Torrelo A, Werfel T, Ring J; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients' Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS). Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018 May;32(5):657-682. doi: 10.1111/jdv.14891.
- Background: PubMed 38553927Ch'ng CC. Rebalancing of the skin microbiome with an emollient 'plus' for effective management of atopic dermatitis: A mini review. Med J Malaysia. 2024 Mar;79(2):203-205.
- Background: PubMed 18795916Gueniche A, Knaudt B, Schuck E, Volz T, Bastien P, Martin R, Rocken M, Breton L, Biedermann T. Effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study. Br J Dermatol. 2008 Dec;159(6):1357-63. doi: 10.1111/j.1365-2133.2008.08836.x. Epub 2008 Sep 15.
- Background: PubMed 37328919Wollenberg A, Kinberger M, Arents B, Aszodi N, Barbarot S, Bieber T, Brough HA, Pinton PC, Christen-Zaech S, Deleuran M, Dittmann M, Fosse N, Gaspar K, Gerbens LAA, Gieler U, Girolomoni G, Gregoriou S, Mortz CG, Nast A, Nygaard U, Rehbinder EM, Ring J, Rossi M, Roxburgh C, Serra-Baldrich E, Simon D, Szalai ZZ, Szepietowski JC, Torrelo A, Werfel T, Flohr C. First update of the living European guideline (EuroGuiDerm) on atopic eczema. J Eur Acad Dermatol Venereol. 2023 Nov;37(11):e1283-e1287. doi: 10.1111/jdv.19269. Epub 2023 Jul 17. No abstract available.
- Background: PubMed 28138262Seite S, Zelenkova H, Martin R. Clinical efficacy of emollients in atopic dermatitis patients - relationship with the skin microbiota modification. Clin Cosmet Investig Dermatol. 2017 Jan 12;10:25-33. doi: 10.2147/CCID.S121910. eCollection 2017.
- Background: PubMed 37092275Magnolo N, Jaenicke T, Tsianakas A, Czech W, Thaci D, Pinter A, Kerob D, Salah S, Luger TA. Comparison of different skin care regimens in patients with moderate to severe atopic dermatitis receiving systemic treatment: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Jun;37 Suppl 5:18-26. doi: 10.1111/jdv.18949. Epub 2023 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqua posae and microresyl and Urea 10% in people with Dermatitis, Atopic, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 6 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 14 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 Indonesia. 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?
SCORAD (Scoring Atopic Dermatitis) (time frame: Through study completion, 12 week). The study lists 4 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 NCT06553417, which also lists 8 linked publications.
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 14 Aug 2024.