AtopicPhase 4NCT05324618
Tacrolimus Versus Hydrocortisone in Atopic Dermatitis
A Phase 4 study testing Tacrolimus and Hydrocortisone in people with Atopic and Dermatitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Atopic, Dermatitis
- What is being tested?
- Tacrolimus and Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2022to 30 Apr 2023
- Phase
- Phase 4
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients
- 2-16 years old
- diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria
Who cannot join
- patients with serious skin disorder other than Atopic Dermatitis
- patients taking systemic corticosteroids or anti-inflammatory medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology Clinic of National Hepatology and Tropical Medicine Research Institute
Cairo, 123456
About this study
Official title: A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis
Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Corticosteroids are the first line and the mainstay therapy in management of atopic dermatitis but have many local and systemic adverse effects. The study aims to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in management of children diagnosed with atopic dermatitis.
Read the detailed description
Atopic dermatitis is a common pruritic inflammatory skin disorder. The prevalence of atopic dermatitis increased in the last three decades by two or three folds worldwide. In the developed countries, atopic dermatitis is estimated to affect 15% to 30% of children and 2% to 10% of adults. This type of dermatitis is usually associated with family history of other atopic disorders such as allergic rhinitis or asthma.
The clinical presentation of Atopic dermatitis differs depending on the age of the patient, it usually begins in infancy with erythematous, papular skin rash that may first appear on the cheeks and chin. In childhood, the skin appears dry, flaky, rough, cracked, and may bleed because of scratching, in adults the lesions are more diffuse with underlying erythema.
This condition is characterized by acute phase where the skin has red scaly patches and chronic phase in which the skin thickens.
Atopic dermatitis is a complex genetic disease where the exact etiology is not entirely known, but it is most probably due to interaction between environmental and genetic factors. The two major groups of involved genes are the genes encoding for epidermal and epithelial structural proteins and the genes regulating the production of cytokines for the immune response.
In atopic dermatitis patients, imbalance occurs between T helper-1 (TH1) and T helper-2 (TH2) immune responses, increased TH2 activity causes the release of interleukin (IL)-3, IL-4, IL-5, IL-10, and IL-13 which results in blood eosinophilia, increased total serum immunoglobulin (Ig) E, and increased growth and development of mast cells.
Atopic dermatitis patients are more likely to develop different skin infections as compared to healthy individuals, including: staphylococcal secondary bacterial infections and herpes simplex viral infection.
Topical corticosteroids (TCS) are the mainstay for management of atopic dermatitis to which other treatments are compared, they act by many pathways to reduce inflammation. Although TCS are effective treatment, they have both local adverse effects as skin thinning, striae, perioral dermatitis, acne, rosacea, telangiectasias, purpura and focal hypertrichosis. Moreover, systemic absorption can lead to systemic effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression, infections, hyperglycemia, cataracts, glaucoma, and growth retardation (in children).
All these side effects are more likely to occur with prolonged use and so seeking for other treatment options is crucial.
Topical calcineurin inhibitors (TCI) as tacrolimus and pimecrolimus are immunosuppressives that help to control the acute flares and decrease the severity of the new flares by acting as immunomodulators. They inhibit the calcineurin so inhibit the T-cell proliferation that produces many inflammatory cytokines such as IL-2, IL-3, IL-4, IL-17, tumor necrosis factor (TNF). TCI is more selective as compared to TCS with less adverse effects so it is considered as an acceptable alternative to TCS.
Tacrolimus 0.03% ointment is approved for moderate to severe atopic dermatitis for ages 2 years and older, with the 0.1% ointment limited to ages 16 years and older; pimecrolimus 1% cream is approved for mild-to-moderate atopic dermatitis for ages 2 years and older. There is limited data comparing TCS with tacrolimus or pimecrolimus.
The FDA has a black box warning for both tacrolimus ointment and pimecrolimus cream about their potential local skin carcinogenesis as seen in animal studies. However, till now there is no causal relationship has been proven between use of a TCI and the development of lymphoma or non-melanoma skin cancer.
This study aims to assess the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in children diagnosed with atopic dermatitis. The primary outcome is to evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream by estimation of the serum level of inflammatory cytokines and the effect on the dermatitis severity scale. The secondary outcome is to evaluate the tacrolimus safety as compared to hydrocortisone through the assessment of treatment related toxicities.
- Conditions
- Atopic, Dermatitis
- Being tested
- Tacrolimus, Hydrocortisone
- Keywords
- Tacrolimus, Hydrocortisone, Atopic, Dermatits, children
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.
0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months.
HydrocortisoneDrug
Also called Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.
1% hydrocortisone cream applied on the affected areas twice daily for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Active comparator | 100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months. Receives: Drug: Tacrolimus |
| Hydrocortisone group | Active comparator | 100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months. Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA)
estimation of the serum level of inflammatory cytokines (biochemical evaluation of IL-10 (pg/ml), IL-17 (pg/ml), IL-23 (pg/ml) using enzyme linked immunosorbent assay technique (ELISA)
Measured: 4 months
severity assessment
Estimation of the effect on the dermatitis severity scale using the modified Eczema Area and Severity Index (mEASI) score. It is a tool used to evaluate the severity of eczema based on body surface area affected by lesions, morphology of lesions (erythema, papules, excoriation, and lichenification), severity of lesions (0-3), and pruritus. The scores range from 0 to 72 for the main symptoms of AD and from 0 to 18 for pruritus, giving a maximum possible score of 0 (no involvement) to 90 (maximum involvement), (0-0.9 clear, 1-8.9 mild, 9.0-29.9 moderate, 30.0-90 severe).
Measured: 4 months
Secondary outcomes (4)
evaluate the tacrolimus safety
assessment of treatment related toxicities; assessment of the incidence rate of burning
Measured: 4 months
evaluation of tacrolimus safety
assessment of other tacrolimus related toxicity; the incidence rate of stinging sensation
Measured: 4 months
evaluation of safety of tacrolimus
assessment of the degree of erythema using Eczema Area and Severity Index (EASI). The EASI is a composite score comprising ratings of the severity of erythema, oedema/induration/papulation, excoriations and lichenification; each on a scale from 0 to 3.
Measured: 4 months
evaluate the hydrocortisone safety
assessment of the incidence rate of skin atrophy and skin infection.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start15 May 2022
- Primary completion20 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AtopicStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, double blinded, simply randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- National Hepatology & Tropical Medicine Research Institute
- Responsible party
- Sponsor
- Investigators
- Amal A. Mohamed, Principal investigator, Department of Biochemistry, National Hepatology and Tropical Medicine Research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324618
- Sponsor's protocol ID
- Tacrolimus vs Hydrocortisone
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alaiti S, Kang S, Fiedler VC, Ellis CN, Spurlin DV, Fader D, Ulyanov G, Gadgil SD, Tanase A, Lawrence I, Scotellaro P, Raye K, Bekersky I. Tacrolimus (FK506) ointment for atopic dermatitis: a phase I study in adults and children. J Am Acad Dermatol. 1998 Jan;38(1):69-76. doi: 10.1016/s0190-9622(98)70541-9.
PubMed 9448208Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.
PubMed 11168575Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
PubMed 11898005Mohamed AA, El Borolossy R, Salah EM, Hussein MS, Muharram NM, Elsalawy N, Khalil MG, Mahmoud MO, El-Amir RY, Elsanhory HMA, Ahmed N, Adaroas AS, Montaser M, El Kholy AA. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023 Sep 20;14:1202325. doi: 10.3389/fphar.2023.1202325. eCollection 2023.
PubMed 37799965
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Trial to Evaluate the Efficacy and Safety of Tacrolimus Versus Hydrocortisone in Treatment of Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05324618
- Acronym / sponsor ID
- Tacrolimus vs Hydrocortisone
- Conditions
- Atopic, Dermatitis
- Keywords
- Tacrolimus, Hydrocortisone, Atopic, Dermatits, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- National Hepatology & Tropical Medicine Research Institute
- Study start
- 15 May 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 12 Apr 2022 (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.
Atopic dermatitis (AD) is a very common inflammatory, genetic skin disorder that occurs more frequently in children. Its exact etiology is not known but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Corticosteroids are the first line and the mainstay therapy in management of atopic dermatitis but have many local and systemic adverse effects. The study aims to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in management of children diagnosed with atopic dermatitis.
Detailed description
Atopic dermatitis is a common pruritic inflammatory skin disorder. The prevalence of atopic dermatitis increased in the last three decades by two or three folds worldwide. In the developed countries, atopic dermatitis is estimated to affect 15% to 30% of children and 2% to 10% of adults. This type of dermatitis is usually associated with family history of other atopic disorders such as allergic rhinitis or asthma.
The clinical presentation of Atopic dermatitis differs depending on the age of the patient, it usually begins in infancy with erythematous, papular skin rash that may first appear on the cheeks and chin. In childhood, the skin appears dry, flaky, rough, cracked, and may bleed because of scratching, in adults the lesions are more diffuse with underlying erythema.
This condition is characterized by acute phase where the skin has red scaly patches and chronic phase in which the skin thickens.
Atopic dermatitis is a complex genetic disease where the exact etiology is not entirely known, but it is most probably due to interaction between environmental and genetic factors. The two major groups of involved genes are the genes encoding for epidermal and epithelial structural proteins and the genes regulating the production of cytokines for the immune response.
In atopic dermatitis patients, imbalance occurs between T helper-1 (TH1) and T helper-2 (TH2) immune responses, increased TH2 activity causes the release of interleukin (IL)-3, IL-4, IL-5, IL-10, and IL-13 which results in blood eosinophilia, increased total serum immunoglobulin (Ig) E, and increased growth and development of mast cells.
Atopic dermatitis patients are more likely to develop different skin infections as compared to healthy individuals, including: staphylococcal secondary bacterial infections and herpes simplex viral infection.
Topical corticosteroids (TCS) are the mainstay for management of atopic dermatitis to which other treatments are compared, they act by many pathways to reduce inflammation. Although TCS are effective treatment, they have both local adverse effects as skin thinning, striae, perioral dermatitis, acne, rosacea, telangiectasias, purpura and focal hypertrichosis. Moreover, systemic absorption can lead to systemic effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression, infections, hyperglycemia, cataracts, glaucoma, and growth retardation (in children).
All these side effects are more likely to occur with prolonged use and so seeking for other treatment options is crucial.
Topical calcineurin inhibitors (TCI) as tacrolimus and pimecrolimus are immunosuppressives that help to control the acute flares and decrease the severity of the new flares by acting as immunomodulators. They inhibit the calcineurin so inhibit the T-cell proliferation that produces many inflammatory cytokines such as IL-2, IL-3, IL-4, IL-17, tumor necrosis factor (TNF). TCI is more selective as compared to TCS with less adverse effects so it is considered as an acceptable alternative to TCS.
Tacrolimus 0.03% ointment is approved for moderate to severe atopic dermatitis for ages 2 years and older, with the 0.1% ointment limited to ages 16 years and older; pimecrolimus 1% cream is approved for mild-to-moderate atopic dermatitis for ages 2 years and older. There is limited data comparing TCS with tacrolimus or pimecrolimus.
The FDA has a black box warning for both tacrolimus ointment and pimecrolimus cream about their potential local skin carcinogenesis as seen in animal studies. However, till now there is no causal relationship has been proven between use of a TCI and the development of lymphoma or non-melanoma skin cancer.
This study aims to assess the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in children diagnosed with atopic dermatitis. The primary outcome is to evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream by estimation of the serum level of inflammatory cytokines and the effect on the dermatitis severity scale. The secondary outcome is to evaluate the tacrolimus safety as compared to hydrocortisone through the assessment of treatment related toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective, double blinded, simply randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Active comparator | Drug: Tacrolimus100 patients treated by thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months. |
| Hydrocortisone group | Active comparator | Drug: Hydrocortisone100 patients treated by thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female patients
- 2-16 years old
- diagnosed with Atopic Dermatitis according to Hanifin and Rajka criteria
Key exclusion criteria (2 listed)
- patients with serious skin disorder other than Atopic Dermatitis
- patients taking systemic corticosteroids or anti-inflammatory medications.
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 |
|---|---|---|
| TacrolimusAlso: Tacrolimus (Tacrolimus 0.03%®) was manufactured by AL-Andalous company for pharmaceutical and chemical industries, Egypt.0.03% topical tacrolimus ointment applied on the affected areas twice daily for 4 months. | Drug | Tacrolimus group |
| HydrocortisoneAlso: Hydrocortisone (Micort 1%®) was manufactured by Cid company for pharmaceutical and chemical industries, Egypt.1% hydrocortisone cream applied on the affected areas twice daily for 4 months. | Drug | Hydrocortisone group |
Primary outcome
evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA)
Time frame: 4 months
estimation of the serum level of inflammatory cytokines (biochemical evaluation of IL-10 (pg/ml), IL-17 (pg/ml), IL-23 (pg/ml) using enzyme linked immunosorbent assay technique (ELISA)
severity assessment
Time frame: 4 months
Estimation of the effect on the dermatitis severity scale using the modified Eczema Area and Severity Index (mEASI) score. It is a tool used to evaluate the severity of eczema based on body surface area affected by lesions, morphology of lesions (erythema, papules, excoriation, and lichenification), severity of lesions (0-3), and pruritus. The scores range from 0 to 72 for the main symptoms of AD and from 0 to 18 for pruritus, giving a maximum possible score of 0 (no involvement) to 90 (maximum involvement), (0-0.9 clear, 1-8.9 mild, 9.0-29.9 moderate, 30.0-90 severe).
4 secondary outcomes
evaluate the tacrolimus safety
Time frame: 4 months
evaluation of tacrolimus safety
Time frame: 4 months
evaluation of safety of tacrolimus
Time frame: 4 months
evaluate the hydrocortisone safety
Time frame: 4 months
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 24 Jul 2023.
- Background: PubMed 9448208Alaiti S, Kang S, Fiedler VC, Ellis CN, Spurlin DV, Fader D, Ulyanov G, Gadgil SD, Tanase A, Lawrence I, Scotellaro P, Raye K, Bekersky I. Tacrolimus (FK506) ointment for atopic dermatitis: a phase I study in adults and children. J Am Acad Dermatol. 1998 Jan;38(1):69-76. doi: 10.1016/s0190-9622(98)70541-9.
- Background: PubMed 11168575Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.
- Background: PubMed 11898005Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
- Derived from this study: PubMed 37799965Mohamed AA, El Borolossy R, Salah EM, Hussein MS, Muharram NM, Elsalawy N, Khalil MG, Mahmoud MO, El-Amir RY, Elsanhory HMA, Ahmed N, Adaroas AS, Montaser M, El Kholy AA. A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children. Front Pharmacol. 2023 Sep 20;14:1202325. doi: 10.3389/fphar.2023.1202325. eCollection 2023.
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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.
Amal A. Mohamed principal investigator
Department of Biochemistry, National Hepatology and Tropical Medicine Research institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus and Hydrocortisone in people with Atopic and Dermatitis, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 2 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 24 Jul 2023. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
evaluate the effect of topical tacrolimus ointment as compared to topical hydrocortisone cream on the serum level of different inflammatory cytokines using enzyme linked immunosorbent assay technique (ELISA) (time frame: 4 months). The study lists 2 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 NCT05324618, which also lists 4 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 24 Jul 2023.