Seborrheic DermatitisPHENOTYPICNCT07297446
Phenotypic and Functional Profile of Peripheral Blood Lymphomonocytes in Seborrheic Dermatitis.
An observational study of Seborrheic Dermatitis and Dietary Habits, run by San Gallicano Dermatological Institute IRCCS at 1 site in Italy.
Trial summary
The protocol describes a prospective, monocentric pilot study conducted at the Istituto Dermatologico San Gallicano (IFO-ISG) aimed at investigating the phenotypic and functional profile of peripheral-blood lymphomonocytes in individuals with seborrheic dermatitis (SD) compared with non-affected controls. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Dermatitis, Dietary Habits
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2024to 10 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of people affected by SD (Seborrheic Dermatitis), both female and male, aged between 45 and 75 years, and healthy subjects selected from personnel undergoing routine examinations by the IFO Occupational Health Unit (Medicina del Lavoro IFO) and among members, friends, and relatives of the personnel of the Cutaneous Physiopathology Unit (UOC Fisiopatologia Cutanea).
Who may be able to join
- Patients affected by Facial Seborrheic Dermatitis (SD) of mild to moderate severity; other sebaceous areas of the body may also be affected.
- Both sexes. Age 45-75 years. Treatments for SD, topical and/or systemic, suspended for at least two (2) weeks.
- Willingness to comply with the appointments/procedures required by the study. Signature of the informed consent.
Who cannot join
- Concomitant dermatological conditions, such as, for example, atopic dermatitis, rosacea, acne, psoriasis, besides the inclusion condition (Seborrheic Dermatitis).
- Diagnosed neurodegenerative diseases. Ongoing pharmacological treatment, topical or systemic, for Seborrheic Dermatitis (SD).
- Immunosuppression. HIV seropositivity.
Trial locations and contacts
1 site in 1 country.
About this study
The protocol describes a prospective, monocentric pilot study conducted at the Istituto Dermatologico San Gallicano (IFO-ISG) aimed at investigating the phenotypic and functional profile of peripheral-blood lymphomonocytes in individuals with seborrheic dermatitis (SD) compared with non-affected controls. A secondary objective is to explore dietary habits in subjects with SD.
Seborrheic dermatitis is a chronic-relapsing inflammatory skin disease, common in infancy, puberty, and adulthood (40-60 years). Its multifactorial etiology involves:
Read more
Sebaceous gland hyperactivity and altered lipid composition promoting Malassezia proliferation;
Metabolic activation of sebaceous glands by Malassezia, which generates irritating fatty acids;
Immune dysregulation, influencing keratinocyte activation and differentiation;
Barrier disruption, clinically resulting in erythema, scaling, and pruritus.
Previous research on immune cells in barrier tissues (gut, lung, skin) suggests that environmental factors-particularly dietary fatty acids and salt intake-modulate the functional polarization of Th17 vs. Treg cells, with implications for autoimmunity. Tissue-resident memory T cells (TRM), abundant in barrier organs, display site-specific homing markers such as CCR4, CCR10, CXCR4, GATA6, and BCL6. In contrast, circulating TEM and TEMRA subsets share common profiles across tissues.
Protocollo_Profilo fenotipico e…
In skin, Th17 cells exhibit variable transcriptional states that may reflect tissue-dependent functional states rather than fixed subtypes. Studies in SD have mainly focused on cutaneous immune responses, highlighting roles for Tγδ cells, cytokines (IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α), and β-defensins, linked to dendritic-cell maturation driven by sebaceous lipids and activation of the NLRP3 inflammasome. Malassezia can also induce IL-1β release from dendritic cells in vitro. However, little is known about how SD affects circulating immune cells or how dietary patterns influence systemic immune responses in this disease.
Study population
The study will include 15 SD patients and 15 non-affected (NA) controls, aged 45-75 years, of both sexes. SD patients must have mild-to-moderate facial involvement and must have stopped topical or systemic treatments for at least two weeks. Exclusion criteria include other skin diseases, neurodegenerative disorders, immunosuppression, ongoing treatments, or HIV positivity. Controls are selected from IFO staff, relatives, and individuals undergoing routine dermatologic examinations.
Methods
After overnight fasting, participants undergo venous blood sampling (7 mL). Plasma is separated and stored at -80°C for secretory and lipidomic profiling. Lymphomonocytes are isolated using Ficoll-Hypaque gradients and analyzed by flow cytometry to characterize immunological phenotypes. Each participant completes a dietary questionnaire at enrollment. Collected data include demographics, clinical history, dietary information, laboratory findings, and SD-specific clinical data (for the patient group).
Statistical plan
As a pilot study, data will be summarized with descriptive statistics only; no formal comparisons will be performed. Findings will generate hypotheses for future research. Recruitment is planned over 18 months, with a total study duration of 24 months.
Ethical and administrative aspects
The study adheres to Good Clinical Practice, the Declaration of Helsinki, and EU/national regulations. Ethical approval is required before initiation. Participants must provide written informed consent for both study participation and data processing. Data will be handled in compliance with GDPR, using pseudonymization, secure storage, and restricted access. Authorized monitors and regulatory authorities may inspect source documents. Biologic samples will be stored until completion of analyses. Results will be published in aggregated, non-identifiable form in scientific journals and conferences.
Read the detailed description
Seborrheic dermatitis (SD) is a chronic-relapsing inflammatory skin disease with three incidence peaks: within the first three months of life, during puberty, and in adulthood (40-60 years). Its etiology is multifactorial and can be attributed to: (I) excessive sebum production by the sebaceous gland (SG) and alterations in its composition, creating an environment favorable to the growth of Malassezia; (II) activation of SG metabolism and its secretory activity by Malassezia, with the release of irritating saturated and unsaturated fatty acids; (III) impaired immune system function, leading to the induction of keratinocyte activation and differentiation; and (IV) disruption of the skin barrier, responsible for clinical manifestations such as erythema, itching, and scaling.
Studies focusing on the presence of immunocompetent cells at barrier sites (intestinal lamina propria, lungs, and skin) have shown that, at the intestinal level, diet and metabolism can influence the phenotype of Th17 lymphocytes. Indeed, dietary enrichment in short-chain fatty acids can promote differentiation toward Treg, whereas the habitual dietary intake of long-chain fatty acids, as well as higher salt consumption, is associated with an increased number of lymphocytes with a Th17 functional profile, and thus with a state of autoimmunity. Barrier sites are typically rich in TRM (tissue-resident memory T) cells, which display site-specific functional profiles tailored to local homing requirements. In the skin, TRM are characterized by high expression of CCR4, CCR10, CXCR4, GATA6, and BCL6. In contrast, the TEM (T effector memory) and TEMRA (terminally differentiated effector memory) compartments appear to share a functional profile across different barrier sites and peripheral tissues.
However, the classification of barrier-site T cells into Th1, Th17, and Th2 subtypes should be viewed in a nuanced way-as an expression of functional characteristics rather than the final outcome of a maturation and differentiation process. In particular, Th17 lymphocytes can modify their functional phenotype, exhibiting distinct transcriptional profiles associated with either homeostatic or pathogenic potential, suggesting that these should be considered tissue-dependent functional states rather than different cell types. Th17 lymphocytes are associated with secretion of IL-17A, IL-17F, and IL-22, and depend on the RORγt-dependent signaling pathway, while TGF-β and IL-6 are required for their generation from naïve T lymphocytes. Studies on the involvement of immune components in the etiopathogenesis of SD have so far focused on the skin, where a role for γδ T cells has been observed, with secretion of IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, β-defensins-likely related to the maturation of dendritic cells induced by sebaceous lipids and the subsequent induction of the NLRP3 inflammasome.
Malassezia itself can induce the release of IL-1β in vitro by dendritic cells obtained from peripheral blood.
No studies are currently available on the possible involvement, in terms of functional modulation, of peripheral blood lymphomonocytes in the pathogenesis of SD.
Likewise, despite known dietary influences on Th17 cell function at barrier sites such as the intestinal mucosa, data are lacking regarding the role of diet and lifestyle in seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis, Dietary Habits
- Keywords
- phenotypic and functional profile, peripheral-blood lymphomonocytes, seborrheic dermatitis (SD)
- Medical subject headings
- Dermatitis, Seborrheic, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Seborrheic Dermatitis (DS) | Participants aged 45-75 years with mild-to-moderate facial seborrheic dermatitis. Additional sebaceous areas may be affected. Blood samples are collected for plasma analysis (secretory and lipidomic profiling) and for lymphomonocyte isolation and flow cytometric phenotyping. Participants also complete a dietary habits questionnaire. | |
| Non-Affected Controls (NA) | Healthy volunteers aged 45-75 years with no seborrheic dermatitis or other relevant dermatologic diseases. Controls undergo the same laboratory and questionnaire procedures as the DS group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic and Functional Profile of Peripheral Blood Lymphomonocytes
Evaluation of the immunological profile of Peripheral Blood Mononuclear Cells (PBMCs) in patients with Seborrheic Dermatitis compared to healthy controls. The analysis includes:
Phenotypic Characterization (Flow Cytometry): Expression of cell surface markers to identify Regulatory T cells (CD45, CD4, CD25, CD127, FoxP3), general immune subsets (CD3, CD4, CD8, CD14, CD16, CD19, CD45, CD56), and activated T cells (CD8, HLA-DR, CD38, CD3, CD4, CD45RA, CD197).
Functional/Secretory Profile (Multiplex/ELISA): Measurement of plasma concentrations of the following cytokines: IL-4, IL-5, IL-8, IL-12, IL-13, IL-18, IL-31, TNF-a, IFN-a, IFN-g, GRO-a, IL-6, IL1a/b, IL-20, IL-23, IL-17A/F, IL-22, GM-CSF, and TSLP.
Measured: Baseline (Day 1)
Secondary outcomes (1)
Assessment of Dietary Habits
Evaluation of dietary habits and lifestyle through a self-administered food frequency and lifestyle questionnaire (including elements of the MeDiWeB questionnaire) to compare nutritional patterns between the Seborrheic Dermatitis group and the control group.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start19 Jun 2024
- Primary completion14 Feb 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- San Gallicano Dermatological Institute IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297446
- Sponsor's protocol ID
- RS 170/ISG/24
- Acronym
- PHENOTYPIC
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Functional Profile of Peripheral Blood Lymphomonocytes in Seborrheic Dermatitis.
- ClinicalTrials.gov ID
- NCT07297446
- Acronym / sponsor ID
- PHENOTYPIC / RS 170/ISG/24
- Conditions
- Seborrheic Dermatitis, Dietary Habits
- Keywords
- phenotypic and functional profile, peripheral-blood lymphomonocytes, seborrheic dermatitis (SD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- San Gallicano Dermatological Institute IRCCSUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The protocol describes a prospective, monocentric pilot study conducted at the Istituto Dermatologico San Gallicano (IFO-ISG) aimed at investigating the phenotypic and functional profile of peripheral-blood lymphomonocytes in individuals with seborrheic dermatitis (SD) compared with non-affected controls. A secondary objective is to explore dietary habits in subjects with SD.
Seborrheic dermatitis is a chronic-relapsing inflammatory skin disease, common in infancy, puberty, and adulthood (40-60 years). Its multifactorial etiology involves:
Sebaceous gland hyperactivity and altered lipid composition promoting Malassezia proliferation;
Metabolic activation of sebaceous glands by Malassezia, which generates irritating fatty acids;
Immune dysregulation, influencing keratinocyte activation and differentiation;
Barrier disruption, clinically resulting in erythema, scaling, and pruritus.
Previous research on immune cells in barrier tissues (gut, lung, skin) suggests that environmental factors-particularly dietary fatty acids and salt intake-modulate the functional polarization of Th17 vs. Treg cells, with implications for autoimmunity. Tissue-resident memory T cells (TRM), abundant in barrier organs, display site-specific homing markers such as CCR4, CCR10, CXCR4, GATA6, and BCL6. In contrast, circulating TEM and TEMRA subsets share common profiles across tissues.
Protocollo_Profilo fenotipico e…
In skin, Th17 cells exhibit variable transcriptional states that may reflect tissue-dependent functional states rather than fixed subtypes. Studies in SD have mainly focused on cutaneous immune responses, highlighting roles for Tγδ cells, cytokines (IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α), and β-defensins, linked to dendritic-cell maturation driven by sebaceous lipids and activation of the NLRP3 inflammasome. Malassezia can also induce IL-1β release from dendritic cells in vitro. However, little is known about how SD affects circulating immune cells or how dietary patterns influence systemic immune responses in this disease.
Study population
The study will include 15 SD patients and 15 non-affected (NA) controls, aged 45-75 years, of both sexes. SD patients must have mild-to-moderate facial involvement and must have stopped topical or systemic treatments for at least two weeks. Exclusion criteria include other skin diseases, neurodegenerative disorders, immunosuppression, ongoing treatments, or HIV positivity. Controls are selected from IFO staff, relatives, and individuals undergoing routine dermatologic examinations.
Methods
After overnight fasting, participants undergo venous blood sampling (7 mL). Plasma is separated and stored at -80°C for secretory and lipidomic profiling. Lymphomonocytes are isolated using Ficoll-Hypaque gradients and analyzed by flow cytometry to characterize immunological phenotypes. Each participant completes a dietary questionnaire at enrollment. Collected data include demographics, clinical history, dietary information, laboratory findings, and SD-specific clinical data (for the patient group).
Statistical plan
As a pilot study, data will be summarized with descriptive statistics only; no formal comparisons will be performed. Findings will generate hypotheses for future research. Recruitment is planned over 18 months, with a total study duration of 24 months.
Ethical and administrative aspects
The study adheres to Good Clinical Practice, the Declaration of Helsinki, and EU/national regulations. Ethical approval is required before initiation. Participants must provide written informed consent for both study participation and data processing. Data will be handled in compliance with GDPR, using pseudonymization, secure storage, and restricted access. Authorized monitors and regulatory authorities may inspect source documents. Biologic samples will be stored until completion of analyses. Results will be published in aggregated, non-identifiable form in scientific journals and conferences.
Detailed description
Seborrheic dermatitis (SD) is a chronic-relapsing inflammatory skin disease with three incidence peaks: within the first three months of life, during puberty, and in adulthood (40-60 years). Its etiology is multifactorial and can be attributed to: (I) excessive sebum production by the sebaceous gland (SG) and alterations in its composition, creating an environment favorable to the growth of Malassezia; (II) activation of SG metabolism and its secretory activity by Malassezia, with the release of irritating saturated and unsaturated fatty acids; (III) impaired immune system function, leading to the induction of keratinocyte activation and differentiation; and (IV) disruption of the skin barrier, responsible for clinical manifestations such as erythema, itching, and scaling.
Studies focusing on the presence of immunocompetent cells at barrier sites (intestinal lamina propria, lungs, and skin) have shown that, at the intestinal level, diet and metabolism can influence the phenotype of Th17 lymphocytes. Indeed, dietary enrichment in short-chain fatty acids can promote differentiation toward Treg, whereas the habitual dietary intake of long-chain fatty acids, as well as higher salt consumption, is associated with an increased number of lymphocytes with a Th17 functional profile, and thus with a state of autoimmunity. Barrier sites are typically rich in TRM (tissue-resident memory T) cells, which display site-specific functional profiles tailored to local homing requirements. In the skin, TRM are characterized by high expression of CCR4, CCR10, CXCR4, GATA6, and BCL6. In contrast, the TEM (T effector memory) and TEMRA (terminally differentiated effector memory) compartments appear to share a functional profile across different barrier sites and peripheral tissues.
However, the classification of barrier-site T cells into Th1, Th17, and Th2 subtypes should be viewed in a nuanced way-as an expression of functional characteristics rather than the final outcome of a maturation and differentiation process. In particular, Th17 lymphocytes can modify their functional phenotype, exhibiting distinct transcriptional profiles associated with either homeostatic or pathogenic potential, suggesting that these should be considered tissue-dependent functional states rather than different cell types. Th17 lymphocytes are associated with secretion of IL-17A, IL-17F, and IL-22, and depend on the RORγt-dependent signaling pathway, while TGF-β and IL-6 are required for their generation from naïve T lymphocytes. Studies on the involvement of immune components in the etiopathogenesis of SD have so far focused on the skin, where a role for γδ T cells has been observed, with secretion of IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, β-defensins-likely related to the maturation of dendritic cells induced by sebaceous lipids and the subsequent induction of the NLRP3 inflammasome.
Malassezia itself can induce the release of IL-1β in vitro by dendritic cells obtained from peripheral blood.
No studies are currently available on the possible involvement, in terms of functional modulation, of peripheral blood lymphomonocytes in the pathogenesis of SD.
Likewise, despite known dietary influences on Th17 cell function at barrier sites such as the intestinal mucosa, data are lacking regarding the role of diet and lifestyle in seborrheic dermatitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seborrheic Dermatitis (DS) | – | –Participants aged 45-75 years with mild-to-moderate facial seborrheic dermatitis. Additional sebaceous areas may be affected. Blood samples are collected for plasma analysis (secretory and lipidomic profiling) and for lymphomonocyte isolation and flow cytometric phenotyping. Participants also complete a dietary habits questionnaire. |
| Non-Affected Controls (NA) | – | –Healthy volunteers aged 45-75 years with no seborrheic dermatitis or other relevant dermatologic diseases. Controls undergo the same laboratory and questionnaire procedures as the DS group. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of people affected by SD (Seborrheic Dermatitis), both female and male, aged between 45 and 75 years, and healthy subjects selected from personnel undergoing routine examinations by the IFO Occupational Health Unit (Medicina del Lavoro IFO) and among members, friends, and relatives of the personnel of the Cutaneous Physiopathology Unit (UOC Fisiopatologia Cutanea).
Key inclusion criteria (3 listed)
- Patients affected by Facial Seborrheic Dermatitis (SD) of mild to moderate severity; other sebaceous areas of the body may also be affected.
- Both sexes. Age 45-75 years. Treatments for SD, topical and/or systemic, suspended for at least two (2) weeks.
- Willingness to comply with the appointments/procedures required by the study. Signature of the informed consent.
Key exclusion criteria (3 listed)
- Concomitant dermatological conditions, such as, for example, atopic dermatitis, rosacea, acne, psoriasis, besides the inclusion condition (Seborrheic Dermatitis).
- Diagnosed neurodegenerative diseases. Ongoing pharmacological treatment, topical or systemic, for Seborrheic Dermatitis (SD).
- Immunosuppression. HIV seropositivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotypic and Functional Profile of Peripheral Blood Lymphomonocytes
Time frame: Baseline (Day 1)
Evaluation of the immunological profile of Peripheral Blood Mononuclear Cells (PBMCs) in patients with Seborrheic Dermatitis compared to healthy controls. The analysis includes: Phenotypic Characterization (Flow Cytometry): Expression of cell surface markers to identify Regulatory T cells (CD45, CD4, CD25, CD127, FoxP3), general immune subsets (CD3, CD4, CD8, CD14, CD16, CD19, CD45, CD56), and activated T cells (CD8, HLA-DR, CD38, CD3, CD4, CD45RA, CD197). Functional/Secretory Profile (Multiplex/ELISA): Measurement of plasma concentrations of the following cytokines: IL-4, IL-5, IL-8, IL-12, IL-13, IL-18, IL-31, TNF-a, IFN-a, IFN-g, GRO-a, IL-6, IL1a/b, IL-20, IL-23, IL-17A/F, IL-22, GM-CSF, and TSLP.
1 secondary outcome
Assessment of Dietary Habits
Time frame: Baseline (Day 1)
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 22 Dec 2025.
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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?
An observational study of Seborrheic Dermatitis and Dietary Habits, run by San Gallicano Dermatological Institute IRCCS at 1 site in Italy.
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 3 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Phenotypic and Functional Profile of Peripheral Blood Lymphomonocytes (time frame: Baseline (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.