Pilot StudyEarly Phase 1NCT06555497
Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis
A Early Phase 1 study testing topical 1% methotrexate gel and clobetasol propionate 0.05% ointment in people with Pilot Study and Psoriasis, run by Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium at 1 site in Philippines.
Trial summary
A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pilot Study, Psoriasis
- What is being tested?
- topical 1% methotrexate gel and clobetasol propionate 0.05% ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Early Phase 1
- 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
- patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease,
- involving less than 30% of the body surface area (BSA)
- negative pregnancy test for female participants of reproductive age
Who cannot join
- patients with psoriatic lesions on the face and/or scalp,
- administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study.
- Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers
- patients planning a pregnancy with their spouses/partners in the next three months.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
Caloocan, National Capital Region, 1427
About this study
Official title: A Pilot Study of Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Mild-moderate Plaque-type Psoriasis
A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Blood chemistry parameters, whole abdomen ultrasound, and adverse drug reactions while on treatment and after eight weeks were monitored as secondary outcome measures.
Read the detailed description
This is a pilot study done for a year at the dermatologic clinic of a tertiary hospital. The study was approved by the Institutional Review Board and followed the declaration of Helsinki Principles for patient rights.
Patients clinically diagnosed with psoriasis were chosen for the study. Inclusion criteria for the participants include the following: patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease, involving less than 30% of the body surface area (BSA) with a negative pregnancy test for female participants of reproductive age. On the other hand, the exclusion criteria for the participants include the following: patients with psoriatic lesions on the face and/or scalp, administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study. Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers, and patients planning a pregnancy with their spouses/partners in the next three months.
The gathered patients with psoriasis were randomly and equally divided, by a tossed coin, into two groups according to the type of treatment the participant received. Group I was treated with the MTX 1% gel while the other group was treated with clobetasol propionate 0.05% ointment. The sampling method used was complete enumeration sampling was used for patients with psoriasis from 2022 to 2023. Should the number of willing participants for the study exceed the determined sample size, only the first patients to satisfy the inclusion criteria were included in the study. The study blinded the participants, the investigators, and the statistician when it came to the treatment involved until the trial was finished.
After the patient agreed to the set guidelines of the study, photographs of the lesions, PASI score, and laboratory parameters including blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and whole abdomen ultrasound were taken at baseline of the study. These laboratories were once again done on week 6 at the end of the application of the assigned topical. The participants were asked to return for follow-up after two weeks of wash-out period, week 8, to see if there was sustained remission defined as no new psoriatic lesion after two weeks of discontinuation of the assigned topical medication. The procedure for this study is detailed in Figure 1.
The withdrawal criteria for the participants in the study were as follows: experienced exacerbation defined as a 125% increase of PASI from the baseline, failure to apply the medication for two consecutive days, failure to appear in one of the follow-up consultations which was done every two weeks. Appearance of adverse drug reactions such as, but not limited to: new lesions, increase in erythema, scaling, or thickening of previous lesions, and intractable pruritus. If any of the abovementioned criteria were present, the participant was asked to discontinue the use of the trial medication and was given the standard treatment therapy (topical corticosteroid) instead.
The intervention used in the study comprised of identical blue-green containers filled with either MTX 1% gel or clobetasol propionate 0.05% ointment and were given to the study participants. They were instructed to apply only to the psoriatic lesion. Participants were educated to recognize common side effects such as stings of dermatitis, irritation, and burning. Each Participant was instructed to apply the given topical formula twice daily for six weeks. No occlusion dressings were used. Avoidance to prolonged sunlight exposure as well as the use of other emollients were advised.
Primary endpoints is the BSA involved in the psoriasis lesions and PASI score. Secondary endpoints include the result of the laboratory parameters of the patient after week six and determination of noted adverse drug reactions on both treatment arms.
The PASI scores of the participants were assessed with an independent sample t-test for comparison between variables.7 Data were analyzed on Statistical Package for Social Science (SPSS) version 11. A p-value of less than 0.05 was considered as significant.
- Conditions
- Pilot Study, Psoriasis
- Being tested
- topical 1% methotrexate gel, clobetasol propionate 0.05% ointment
- Keywords
- topical methotrexate gel, Clobetasol
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical 1% methotrexate gelDrug
Also called clobetasol propionate 0.05% ointment
topical 1% methotrexate gel
clobetasol propionate 0.05% ointmentDrug
clobetasol propionate 0.05% ointment
| Study group | Role | What they receive |
|---|---|---|
| topical 1% methotrexate gel | Experimental | topical 1% methotrexate gel 2x a day for 6 weeks Receives: Drug: topical 1% methotrexate gel |
| clobetasol propionate 0.05% ointment | Active comparator | clobetasol propionate 0.05% ointment 2x a day for 6 weeks Receives: Drug: clobetasol propionate 0.05% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area and Severity Index (PASI) score computed
Psoriasis Area and Severity Index scores range from 0 to 72. In general, the higher the PASI score, the more severe is the disease
Measured: 8 weeks
Secondary outcomes (5)
Change in baseline laboratory results
blood urea nitrogen (BUN)
Measured: 8 weeks
Change in baseline laboratory results
creatinine
Measured: 8 weeks
Change in baseline laboratory results
alanine aminotransferase (ALT)
Measured: 8 weeks
Change in baseline laboratory results
aspartate aminotransferase (AST)
Measured: 8 weeks
Change in baseline laboratory results
whole abdomen ultrasound
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pilot StudyStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Benjamin B. Gochoco, Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
- Investigators
- John Benjamin B Gochoco, MD, Principal investigator, Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555497
- Sponsor's protocol ID
- JNRodriguezMHS
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole study will be available
Publications
Kimwell MJM, de Guzman DC, Onda AJM, Dofitas BL, Frez MLF, Mendoza CG, Rivera FD 4th, Almirol BJQ, Malaluan MJQ, Guce K. Economic Evaluation of Selected Interleukin Inhibitors Versus Methotrexate for Moderate-to-Severe Plaque Psoriasis From the Philippine Payer Perspective. Value Health Reg Issues. 2023 Mar;34:100-107. doi: 10.1016/j.vhri.2022.12.001. Epub 2023 Jan 11.
PubMed 36638606Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
PubMed 19641206Sarac G, Koca TT, Baglan T. A brief summary of clinical types of psoriasis. North Clin Istanb. 2016 Jun 14;3(1):79-82. doi: 10.14744/nci.2016.16023. eCollection 2016.
PubMed 28058392Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.
PubMed 22250239Haider S, Wahid Z, Najam-Us-Saher, Riaz F. Efficacy of Methotrexate in patients with plaque type psoriasis. Pak J Med Sci. 2014 Sep;30(5):1050-3. doi: 10.12669/pjms.305.4451.
PubMed 25225524Pinto MF, Moura CC, Nunes C, Segundo MA, Costa Lima SA, Reis S. A new topical formulation for psoriasis: development of methotrexate-loaded nanostructured lipid carriers. Int J Pharm. 2014 Dec 30;477(1-2):519-26. doi: 10.1016/j.ijpharm.2014.10.067. Epub 2014 Nov 1.
PubMed 25445970Dawson, B., & Trapp, R. G. (2001). Basic et clinical biostatistics. Buch. Lange Med. Books/Mcgraw-Hill.
Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.
PubMed 25396122Zhou Y, Yang L, Lyu Y, Wu D, Zhu Y, Li J, Jiang D, Xin X, Yin L. Topical Delivery of ROS-Responsive Methotrexate Prodrug Nanoassemblies by a Dissolvable Microneedle Patch for Psoriasis Therapy. Int J Nanomedicine. 2023 Feb 18;18:899-915. doi: 10.2147/IJN.S394957. eCollection 2023.
PubMed 36824414
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Mild-moderate Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT06555497
- Acronym / sponsor ID
- JNRodriguezMHS
- Conditions
- Pilot Study, Psoriasis
- Keywords
- topical methotrexate gel, Clobetasol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dr. Jose N. Rodriguez Memorial Hospital and SanitariumUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 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.
A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Blood chemistry parameters, whole abdomen ultrasound, and adverse drug reactions while on treatment and after eight weeks were monitored as secondary outcome measures.
Detailed description
This is a pilot study done for a year at the dermatologic clinic of a tertiary hospital. The study was approved by the Institutional Review Board and followed the declaration of Helsinki Principles for patient rights.
Patients clinically diagnosed with psoriasis were chosen for the study. Inclusion criteria for the participants include the following: patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease, involving less than 30% of the body surface area (BSA) with a negative pregnancy test for female participants of reproductive age. On the other hand, the exclusion criteria for the participants include the following: patients with psoriatic lesions on the face and/or scalp, administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study. Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers, and patients planning a pregnancy with their spouses/partners in the next three months.
The gathered patients with psoriasis were randomly and equally divided, by a tossed coin, into two groups according to the type of treatment the participant received. Group I was treated with the MTX 1% gel while the other group was treated with clobetasol propionate 0.05% ointment. The sampling method used was complete enumeration sampling was used for patients with psoriasis from 2022 to 2023. Should the number of willing participants for the study exceed the determined sample size, only the first patients to satisfy the inclusion criteria were included in the study. The study blinded the participants, the investigators, and the statistician when it came to the treatment involved until the trial was finished.
After the patient agreed to the set guidelines of the study, photographs of the lesions, PASI score, and laboratory parameters including blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and whole abdomen ultrasound were taken at baseline of the study. These laboratories were once again done on week 6 at the end of the application of the assigned topical. The participants were asked to return for follow-up after two weeks of wash-out period, week 8, to see if there was sustained remission defined as no new psoriatic lesion after two weeks of discontinuation of the assigned topical medication. The procedure for this study is detailed in Figure 1.
The withdrawal criteria for the participants in the study were as follows: experienced exacerbation defined as a 125% increase of PASI from the baseline, failure to apply the medication for two consecutive days, failure to appear in one of the follow-up consultations which was done every two weeks. Appearance of adverse drug reactions such as, but not limited to: new lesions, increase in erythema, scaling, or thickening of previous lesions, and intractable pruritus. If any of the abovementioned criteria were present, the participant was asked to discontinue the use of the trial medication and was given the standard treatment therapy (topical corticosteroid) instead.
The intervention used in the study comprised of identical blue-green containers filled with either MTX 1% gel or clobetasol propionate 0.05% ointment and were given to the study participants. They were instructed to apply only to the psoriatic lesion. Participants were educated to recognize common side effects such as stings of dermatitis, irritation, and burning. Each Participant was instructed to apply the given topical formula twice daily for six weeks. No occlusion dressings were used. Avoidance to prolonged sunlight exposure as well as the use of other emollients were advised.
Primary endpoints is the BSA involved in the psoriasis lesions and PASI score. Secondary endpoints include the result of the laboratory parameters of the patient after week six and determination of noted adverse drug reactions on both treatment arms.
The PASI scores of the participants were assessed with an independent sample t-test for comparison between variables.7 Data were analyzed on Statistical Package for Social Science (SPSS) version 11. A p-value of less than 0.05 was considered as significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical 1% methotrexate gel | Experimental | Drug: topical 1% methotrexate geltopical 1% methotrexate gel 2x a day for 6 weeks |
| clobetasol propionate 0.05% ointment | Active comparator | Drug: clobetasol propionate 0.05% ointmentclobetasol propionate 0.05% ointment 2x a day for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease,
- involving less than 30% of the body surface area (BSA)
- negative pregnancy test for female participants of reproductive age
Key exclusion criteria (4 listed)
- patients with psoriatic lesions on the face and/or scalp,
- administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study.
- Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers
- patients planning a pregnancy with their spouses/partners in the next three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical 1% methotrexate gelAlso: clobetasol propionate 0.05% ointmenttopical 1% methotrexate gel | Drug | topical 1% methotrexate gel |
| clobetasol propionate 0.05% ointmentclobetasol propionate 0.05% ointment | Drug | clobetasol propionate 0.05% ointment |
Primary outcome
Change in Psoriasis Area and Severity Index (PASI) score computed
Time frame: 8 weeks
Psoriasis Area and Severity Index scores range from 0 to 72. In general, the higher the PASI score, the more severe is the disease
5 secondary outcomes
Change in baseline laboratory results
Time frame: 8 weeks
Change in baseline laboratory results
Time frame: 8 weeks
Change in baseline laboratory results
Time frame: 8 weeks
Change in baseline laboratory results
Time frame: 8 weeks
Change in baseline laboratory results
Time frame: 8 weeks
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 16 Aug 2024.
- Background: PubMed 36638606Kimwell MJM, de Guzman DC, Onda AJM, Dofitas BL, Frez MLF, Mendoza CG, Rivera FD 4th, Almirol BJQ, Malaluan MJQ, Guce K. Economic Evaluation of Selected Interleukin Inhibitors Versus Methotrexate for Moderate-to-Severe Plaque Psoriasis From the Philippine Payer Perspective. Value Health Reg Issues. 2023 Mar;34:100-107. doi: 10.1016/j.vhri.2022.12.001. Epub 2023 Jan 11.
- Background: PubMed 19641206Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Background: PubMed 28058392Sarac G, Koca TT, Baglan T. A brief summary of clinical types of psoriasis. North Clin Istanb. 2016 Jun 14;3(1):79-82. doi: 10.14744/nci.2016.16023. eCollection 2016.
- Background: PubMed 22250239Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.
- Background: PubMed 25225524Haider S, Wahid Z, Najam-Us-Saher, Riaz F. Efficacy of Methotrexate in patients with plaque type psoriasis. Pak J Med Sci. 2014 Sep;30(5):1050-3. doi: 10.12669/pjms.305.4451.
- Background: PubMed 25445970Pinto MF, Moura CC, Nunes C, Segundo MA, Costa Lima SA, Reis S. A new topical formulation for psoriasis: development of methotrexate-loaded nanostructured lipid carriers. Int J Pharm. 2014 Dec 30;477(1-2):519-26. doi: 10.1016/j.ijpharm.2014.10.067. Epub 2014 Nov 1.
- BackgroundDawson, B., & Trapp, R. G. (2001). Basic et clinical biostatistics. Buch. Lange Med. Books/Mcgraw-Hill.
- Background: PubMed 25396122Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.
- Background: PubMed 36824414Zhou Y, Yang L, Lyu Y, Wu D, Zhu Y, Li J, Jiang D, Xin X, Yin L. Topical Delivery of ROS-Responsive Methotrexate Prodrug Nanoassemblies by a Dissolvable Microneedle Patch for Psoriasis Therapy. Int J Nanomedicine. 2023 Feb 18;18:899-915. doi: 10.2147/IJN.S394957. eCollection 2023.
- Individual participant dataSharing planned: Yes. The whole study will be available
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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.
John Benjamin B Gochoco, MD principal investigator
Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing topical 1% methotrexate gel and clobetasol propionate 0.05% ointment in people with Pilot Study and Psoriasis, run by Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium at 1 site in Philippines.
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 4 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 16 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 Philippines. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Psoriasis Area and Severity Index (PASI) score computed (time frame: 8 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 NCT06555497, which also lists 9 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 16 Aug 2024.