Alopecia AreataPhase 4NCT06399783
Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata
A Phase 4 study testing Simvastatin, Mometasone Furoate and Fractional CO2 laser in people with Alopecia Areata, run by Assiut University at 1 site in Egypt.
Trial summary
Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring hair loss of the scalp or any hair-bearing surface. Alopecia areata affects approximately 2% of the general population. AA has a significant influence on patients' quality of life and may induce psychological disorders. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Simvastatin, Mometasone Furoate and Fractional CO2 laser
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Dec 2027
- Phase
- Phase 4
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with patchy alopecia areata involving < 50% of the total scalp.
Who cannot join
- Alopecia totalis and alopecia universalis.
- Cicatricial alopecia.
- Other causes of hair loss such as; endocrine or immunological disease.
- Skin disease in the affected area.
- Hypersensitivity or allergy to any of the treatment products used.
- Patient using treatment (topical or systemic) for alopecia areata in the last 2 months.
Show all 9Show fewer
- Pregnant and lactating females.
- Patients with history of hypertrophic scars or keloid formation.
- Patients with active infection at the site of the lesion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut, 73333
Alaa M Ghazally, PHD, 00201007224787, alaa_ghazally@aun.edu.eg
About this study
Official title: Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata: Clinical, Dermoscopic and Immunohistochemical Study
Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring hair loss of the scalp or any hair-bearing surface.
Alopecia areata affects approximately 2% of the general population. AA has a significant influence on patients' quality of life and may induce psychological disorders.
Read more
In AA, CD4+ and CD8+ T-cells violate the immune privilege of the anagen hair follicle, leading to loss of the growing hair shaft. A genome-wide association study demonstrated a genetic predisposition to AA . Additionally, environmental insults, such as viral infections, trauma, or psychosocial stress, have also been suspected to possibly contribute to the development of the disease .
The clinical manifestations of AA vary from small well-defined patches of hair loss to the diffuse involvement of the scalp or the entire body. The majority of AA patients experience unpredictable relapsing and remitting episodes. In a number of patients, it can be persistent, especially when the hair loss is extensive.
Read the detailed description
There are many treatment modalities for AA including topical treatment, intralesional injections, systemic corticosteroids, systemic immunosuppressants like methotrexate or cyclosporine, excimer laser and photochemotherapy . To date, the majority of traditional treatments for AA are of limited efficacy with a high risk of adverse effects .
Topical corticosteroids are widely used in the treatment of limited patchy AA and as a first-line therapy for children. They are also recommended as an adjunctive therapy to systemic treatments in more severe forms .
Statins are well known lipid-lowering medications. They have anti-inflammatory and immunomodulatory effects. Simvastatin belongs to the statin family. Lately, Simvastatin is utilized in treatment of several dermatological diseases . It showed efficacy in treatment of psoriasis, vitiligo, xanthomas , atopic dermatitis and acne vulgaris.
In several case reports, AA patients were successfully treated with systemic simvastatin . DelCanto, 2020 studied the effect of topical simvastatin in animal model of AA and concluded that it induced hair re-growth, suggesting that it could be a new efficient therapy for AA.
Statins are theorized to induce hair regrowth in AA by inhibiting signal transducers and activators of transcription (STAT) phosphorylation that activates several important inflammatory cytokines and also by altering the balance of Th1/Th2, suppressing IL-17, and inhibiting lymphocyte migration.
Fractional laser has been reported to be successful in treating AA. Fractional CO2 laser is assumed to help in treatment of AA through stimulation of T-cell apoptosis, arrest of hair follicles in the telogen stage, and promotion of the anagen stage. Also, Fractional CO2 laser creates microchannels in the epidermis to improve drug delivery into the skin.
- Conditions
- Alopecia Areata
- Being tested
- Simvastatin, Mometasone Furoate, Fractional CO2 laser
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Group of patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months, while another group will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin.
Mometasone FuroateDrug
Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of Mometasone Furoate.
Fractional CO2 laserProcedure or surgery
Fractional CO2 laser will be used for assisted drug delivery for both topical simvastatin and mometasone Furoate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hair regrowth in alopecia areata using SALT score.
The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40% (0.40), right side = 18% (0.18), left side = 18% (0.18) and the posterior aspect = 24% (0.24). Percentage of hair loss in any of the four areas is multiplied by the percentage of the scalp covered in that area. The SALT score is the sum of the percentage of hair loss in all the areas mentioned above.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Patients will be divided randomly into three groups: Group A: Patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months. Group B: Patients will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin. Group C: Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of topical steroid.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Ahmed Makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399783
- Sponsor's protocol ID
- Sim vs Cs
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Adami M, Prudente Ada S, Mendes DA, Horinouchi CD, Cabrini DA, Otuki MF. Simvastatin ointment, a new treatment for skin inflammatory conditions. J Dermatol Sci. 2012 May;66(2):127-35. doi: 10.1016/j.jdermsci.2012.02.015. Epub 2012 Mar 3.
PubMed 22455735Ahmadvand A, Yazdanfar A, Yasrebifar F, Mohammadi Y, Mahjub R, Mehrpooya M. Evaluating the Effects of Oral and Topical Simvastatin in the Treatment of Acne Vulgaris: A Double-blind, Randomized, Placebo-controlled Clinical Trial. Curr Clin Pharmacol. 2018;13(4):279-283. doi: 10.2174/1574884713666180821143545.
PubMed 30129417Al Salman M, Ghiasi M, Farid AS, Taraz M, Azizpour A, Mahmoudi H. Oral simvastatin combined with narrowband UVB for the treatment of psoriasis: A randomized controlled trial. Dermatol Ther. 2021 Sep;34(5):e15075. doi: 10.1111/dth.15075. Epub 2021 Aug 19.
PubMed 34327798Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013.
PubMed 29273101Cheung K, Powers EM, McKillip J, Powers JG. Effect of statin use on incidence of eczema and atopic dermatitis: A retrospective cohort study. J Am Acad Dermatol. 2021 Feb;84(2):534-535. doi: 10.1016/j.jaad.2020.05.015. Epub 2020 May 11. No abstract available.
PubMed 32407738Childs JM, Sperling LC. Histopathology of scarring and nonscarring hair loss. Dermatol Clin. 2013 Jan;31(1):43-56. doi: 10.1016/j.det.2012.08.001. Epub 2012 Sep 26.
PubMed 23159175Cho S, Choi MJ, Zheng Z, Goo B, Kim DY, Cho SB. Clinical effects of non-ablative and ablative fractional lasers on various hair disorders: a case series of 17 patients. J Cosmet Laser Ther. 2013 Apr;15(2):74-9. doi: 10.3109/14764172.2013.764436. Epub 2013 Mar 6.
PubMed 23464363Choi JW, Suh DW, Lew BL, Sim WY. Simvastatin/Ezetimibe Therapy for Recalcitrant Alopecia Areata: An Open Prospective Study of 14 Patients. Ann Dermatol. 2017 Dec;29(6):755-760. doi: 10.5021/ad.2017.29.6.755. Epub 2017 Oct 30.
PubMed 29200765El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.
PubMed 32478930Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015 Feb;14(2):81-9. doi: 10.1016/j.autrev.2014.10.014. Epub 2014 Oct 12.
PubMed 25315746Issa MC, Pires M, Silveira P, Xavier de Brito E, Sasajima C. Transepidermal drug delivery: a new treatment option for areata alopecia? J Cosmet Laser Ther. 2015 Feb;17(1):37-40. doi: 10.3109/14764172.2014.967778. Epub 2014 Oct 16.
PubMed 25260052Karimkhani C, Boyers LN, Prescott L, Welch V, Delamere FM, Nasser M, Zaveri A, Hay RJ, Vos T, Murray CJ, Margolis DJ, Hilton J, MacLehose H, Williams HC, Dellavalle RP. Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews. JAMA Dermatol. 2014 Sep;150(9):945-51. doi: 10.1001/jamadermatol.2014.709.
PubMed 24807687Lattouf C, Jimenez JJ, Tosti A, Miteva M, Wikramanayake TC, Kittles C, Herskovitz I, Handler MZ, Fabbrocini G, Schachner LA. Treatment of alopecia areata with simvastatin/ezetimibe. J Am Acad Dermatol. 2015 Feb;72(2):359-61. doi: 10.1016/j.jaad.2014.11.006. No abstract available.
PubMed 25592347Lee HH, Gwillim E, Patel KR, Hua T, Rastogi S, Ibler E, Silverberg JI. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis. J Am Acad Dermatol. 2020 Mar;82(3):675-682. doi: 10.1016/j.jaad.2019.08.032. Epub 2019 Aug 19.
PubMed 31437543Li A, Meng X, Xing X, Tan H, Liu J, Li C. Efficacy and Influence Factors of 308-nm Excimer Lamp with Minoxidil in the Treatment of Alopecia Areata. Lasers Surg Med. 2020 Oct;52(8):761-767. doi: 10.1002/lsm.23210. Epub 2020 Jan 9.
PubMed 31919885
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata: Clinical, Dermoscopic and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT06399783
- Acronym / sponsor ID
- Sim vs Cs
- Conditions
- Alopecia Areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 May 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.
Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring hair loss of the scalp or any hair-bearing surface.
Alopecia areata affects approximately 2% of the general population. AA has a significant influence on patients' quality of life and may induce psychological disorders.
In AA, CD4+ and CD8+ T-cells violate the immune privilege of the anagen hair follicle, leading to loss of the growing hair shaft. A genome-wide association study demonstrated a genetic predisposition to AA . Additionally, environmental insults, such as viral infections, trauma, or psychosocial stress, have also been suspected to possibly contribute to the development of the disease .
The clinical manifestations of AA vary from small well-defined patches of hair loss to the diffuse involvement of the scalp or the entire body. The majority of AA patients experience unpredictable relapsing and remitting episodes. In a number of patients, it can be persistent, especially when the hair loss is extensive.
Detailed description
There are many treatment modalities for AA including topical treatment, intralesional injections, systemic corticosteroids, systemic immunosuppressants like methotrexate or cyclosporine, excimer laser and photochemotherapy . To date, the majority of traditional treatments for AA are of limited efficacy with a high risk of adverse effects .
Topical corticosteroids are widely used in the treatment of limited patchy AA and as a first-line therapy for children. They are also recommended as an adjunctive therapy to systemic treatments in more severe forms .
Statins are well known lipid-lowering medications. They have anti-inflammatory and immunomodulatory effects. Simvastatin belongs to the statin family. Lately, Simvastatin is utilized in treatment of several dermatological diseases . It showed efficacy in treatment of psoriasis, vitiligo, xanthomas , atopic dermatitis and acne vulgaris.
In several case reports, AA patients were successfully treated with systemic simvastatin . DelCanto, 2020 studied the effect of topical simvastatin in animal model of AA and concluded that it induced hair re-growth, suggesting that it could be a new efficient therapy for AA.
Statins are theorized to induce hair regrowth in AA by inhibiting signal transducers and activators of transcription (STAT) phosphorylation that activates several important inflammatory cytokines and also by altering the balance of Th1/Th2, suppressing IL-17, and inhibiting lymphocyte migration.
Fractional laser has been reported to be successful in treating AA. Fractional CO2 laser is assumed to help in treatment of AA through stimulation of T-cell apoptosis, arrest of hair follicles in the telogen stage, and promotion of the anagen stage. Also, Fractional CO2 laser creates microchannels in the epidermis to improve drug delivery into the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Model description
- Patients will be divided randomly into three groups: Group A: Patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months. Group B: Patients will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin. Group C: Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of topical steroid.
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with patchy alopecia areata involving < 50% of the total scalp.
Key exclusion criteria (9 listed)
- Alopecia totalis and alopecia universalis.
- Cicatricial alopecia.
- Other causes of hair loss such as; endocrine or immunological disease.
- Skin disease in the affected area.
- Hypersensitivity or allergy to any of the treatment products used.
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 |
|---|---|---|
| SimvastatinGroup of patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months, while another group will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin. | Drug | – |
| Mometasone FuroatePatients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of Mometasone Furoate. | Drug | – |
| Fractional CO2 laserFractional CO2 laser will be used for assisted drug delivery for both topical simvastatin and mometasone Furoate. | Procedure or surgery | – |
Primary outcome
Evaluation of hair regrowth in alopecia areata using SALT score.
Time frame: 24 weeks
The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40% (0.40), right side = 18% (0.18), left side = 18% (0.18) and the posterior aspect = 24% (0.24). Percentage of hair loss in any of the four areas is multiplied by the percentage of the scalp covered in that area. The SALT score is the sum of the percentage of hair loss in all the areas mentioned above.
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 6 May 2024.
- Background: PubMed 22455735Adami M, Prudente Ada S, Mendes DA, Horinouchi CD, Cabrini DA, Otuki MF. Simvastatin ointment, a new treatment for skin inflammatory conditions. J Dermatol Sci. 2012 May;66(2):127-35. doi: 10.1016/j.jdermsci.2012.02.015. Epub 2012 Mar 3.
- Background: PubMed 30129417Ahmadvand A, Yazdanfar A, Yasrebifar F, Mohammadi Y, Mahjub R, Mehrpooya M. Evaluating the Effects of Oral and Topical Simvastatin in the Treatment of Acne Vulgaris: A Double-blind, Randomized, Placebo-controlled Clinical Trial. Curr Clin Pharmacol. 2018;13(4):279-283. doi: 10.2174/1574884713666180821143545.
- Background: PubMed 34327798Al Salman M, Ghiasi M, Farid AS, Taraz M, Azizpour A, Mahmoudi H. Oral simvastatin combined with narrowband UVB for the treatment of psoriasis: A randomized controlled trial. Dermatol Ther. 2021 Sep;34(5):e15075. doi: 10.1111/dth.15075. Epub 2021 Aug 19.
- Background: PubMed 29273101Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013.
- Background: PubMed 32407738Cheung K, Powers EM, McKillip J, Powers JG. Effect of statin use on incidence of eczema and atopic dermatitis: A retrospective cohort study. J Am Acad Dermatol. 2021 Feb;84(2):534-535. doi: 10.1016/j.jaad.2020.05.015. Epub 2020 May 11. No abstract available.
- Background: PubMed 23159175Childs JM, Sperling LC. Histopathology of scarring and nonscarring hair loss. Dermatol Clin. 2013 Jan;31(1):43-56. doi: 10.1016/j.det.2012.08.001. Epub 2012 Sep 26.
- Background: PubMed 23464363Cho S, Choi MJ, Zheng Z, Goo B, Kim DY, Cho SB. Clinical effects of non-ablative and ablative fractional lasers on various hair disorders: a case series of 17 patients. J Cosmet Laser Ther. 2013 Apr;15(2):74-9. doi: 10.3109/14764172.2013.764436. Epub 2013 Mar 6.
- Background: PubMed 29200765Choi JW, Suh DW, Lew BL, Sim WY. Simvastatin/Ezetimibe Therapy for Recalcitrant Alopecia Areata: An Open Prospective Study of 14 Patients. Ann Dermatol. 2017 Dec;29(6):755-760. doi: 10.5021/ad.2017.29.6.755. Epub 2017 Oct 30.
- Background: PubMed 32478930El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.
- Background: PubMed 25315746Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015 Feb;14(2):81-9. doi: 10.1016/j.autrev.2014.10.014. Epub 2014 Oct 12.
- Background: PubMed 25260052Issa MC, Pires M, Silveira P, Xavier de Brito E, Sasajima C. Transepidermal drug delivery: a new treatment option for areata alopecia? J Cosmet Laser Ther. 2015 Feb;17(1):37-40. doi: 10.3109/14764172.2014.967778. Epub 2014 Oct 16.
- Background: PubMed 24807687Karimkhani C, Boyers LN, Prescott L, Welch V, Delamere FM, Nasser M, Zaveri A, Hay RJ, Vos T, Murray CJ, Margolis DJ, Hilton J, MacLehose H, Williams HC, Dellavalle RP. Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews. JAMA Dermatol. 2014 Sep;150(9):945-51. doi: 10.1001/jamadermatol.2014.709.
- Individual participant dataSharing planned: Yes
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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.
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 Simvastatin, Mometasone Furoate and Fractional CO2 laser in people with Alopecia Areata, run by Assiut 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 1 inclusion and 9 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 6 May 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 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?
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 Hana A Morsy, professor (00201064447881, hanan_morsy2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of hair regrowth in alopecia areata using SALT score. (time frame: 24 weeks). 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 NCT06399783, which also lists 26 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 6 May 2024.