Oral Lichen PlanusPhase 2NCT03386643
Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus
A Phase 2 study testing Bifidobacterium animalis subsp. lactis HN019 and Clobetasol propionate 0.05% in people with Oral Lichen Planus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1 to 4% of the general population, with a higher incidence in women, around the 4th and 5th decades of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Bifidobacterium animalis subsp. lactis HN019 and Clobetasol propionate 0.05%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2017to 6 Dec 2019
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical inclusion
- Adults ≥ 18 years old, both genres, who consent to participate of the study;
- Presence of symptomatic reticular lesion and/or white-gray papules. In afro-descendent individuals, reticular lesions may be associated with hyperpigmented lesions;
- Additional clinical features such as ulcerative, erythematous, plaque and bullous lesions will be accepted in the presence of bilateral and symmetrical reticular lesions.
- Histopathological inclusion criteria
- Presence of subepithelial infiltrate predominantly lymphocytic, in band and confined to the subepithelial area.
- Liquefaction degeneration of the basal cells layer.
Who cannot join
- Clinical exclusion criteria
- Exclusion of contact lichenoid lesions: the pattern of reticular lesion and / or papules should not be present only in areas of physical contact with restorative materials;
- Exclusion of lichenoid reaction to the drug: difficult to differentiate from OLP, however it is necessary to report all drugs in use by the patient; the comparison between patients on medication, and those who do not use medication is important to establish subgroups of OLP;
- Exclusion of chronic graft versus host disease (GVHD): differentiation between OLP and GVHD is established in most cases by medical history;
- Exclusion of immunocompromised patients or patients with systemic diseases of high complexity.
- Exclusion of patients who have previously used probiotic bacteria in the last 4 weeks prior to the study.
- Histopathological criteria for exclusion • Presence of epithelial dysplasia, absence of the lymphocytic inflammatory infiltrate band and liquefaction degeneration.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Effect of the Probiotic Bifidobacterium Animalis Subsp. Lactis HN019 on Clinical, Histopathological and Immunophenotypic Features of Oral Lichen Planus
Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1 to 4% of the general population, with a higher incidence in women, around the 4th and 5th decades of life. Although the pathogenesis of OLP is related to a immune-cellular response, mainly mediated by T lymphocytes, its cause remains unknown. Considering its chronic nature, control of OLP aims to reduce symptoms and improve function, and agents with anti-inflammatory action, especially topical corticosteroids result in some degree of success in most patients, depending on the clinical presentation. However, some cases are resistant to the use of corticosteroids, thus justifying the search for new therapeutic options. The immunomodulation proved to be one of the main functions of probiotic bacteria, and recent studies have shown effect of probiotics on decreasing the expression of inflammatory markers, which enables the study of this therapy as an alternative to the control of OLP. Thus, this project aims to evaluate the effects of therapy with Bifidobacterium animalis subsp. lactis HN019 comparing with clobetasol propionate 0.05% in symptomatic patients with OLP referred for diagnosis and treatment of School of Dentistry of Ribeirão Preto - University of São Paulo (USP). The impact of the topical therapy (probiotic or corticosteroid) on the clinical, histopathological and immunopathological features will be evaluated. This project was previously submitted and approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto/USP, and all patients must give informed consent to participate in this study.
Read the detailed description
This is a randomized double-blind clinical trial with symptomatic patients presenting OLP, which will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol propionate 0.05%. The selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 (experimental group) or 0.05% clobetasol propionate (control group) for mouth washing, twice a day for 4 weeks. Patients will be instructed to maintain normal brushing and not to use or consume another corticosteroid and /or probiotic during the study. Outcomes measures will be symptoms (VAS and Likert-like scale), quality of life (SF-36 form), and clinical changes (erythema, reticulation, erosion/ulcer based on clinical photographs), which will be performed at baseline, 15 days (only VAS, Likert-like scale and photographs) and and at one month of treatment. All patients will undergo biopsies for the diagnosis of OLP, and those who consent will be submitted to an optional biopsy at the end of the topical treatment for histopathological and immunopathological characterization.
- Conditions
- Oral Lichen Planus
- Being tested
- Bifidobacterium animalis subsp. lactis HN019, Clobetasol propionate 0.05%
- Keywords
- Oral lichen planus, Probiotics, Immunomodulation.
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactis HN019Drug
Also called Probiotic
The selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 for mouthwash twice a day for 4 weeks.
Clobetasol propionate 0.05%Drug
Also called Topical corticosteroid
The selected patients will receive capsules to be diluted in 15ml of water containing clobetasol propionate 0.05% for mouthwash twice a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium animalis subsp. lactis | Experimental | Intervention:
Bifidobacterium animalis subsp. lactis HN019 Receives: Drug: Bifidobacterium animalis subsp. lactis HN019 |
| Clobetasol propionate 0.05% | Active comparator | Intervention:
Clobetasol propionate 0.05% Receives: Drug: Clobetasol propionate 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms intensity measure
Self reported symptoms at baseline, 15 and 30 days after therapy through an visual analogue scale (VAS). It consists of a subjective scale scoring the symptoms from 0 to 10 (0 = no symptoms and 10 = as bad as can be).
Measured: 4 weeks
Secondary outcomes (3)
Histopathological analysis
Biopsies will be collected at the baseline stage or at the time of the diagnosis of OLP (optional), consisting of a 5mm x 5mm fragment or a 4mm punch of reticular lesions. The second biopsy will be optional, with patient consent, close to the area of the first biopsy for comparative purposes. The histological findings will be determined quantitatively and qualitatively regarding the presence of epithelial hyperplasia, degeneration by liquefaction of the basal cells layer, lymphocytic infiltrate in the subepithelial connective tissue, and apoptotic cells. Photographs will be used at 400x and quantification using the Image J. program.
Measured: Before (baseline) and one month after intensive topical therapy
Immunohistochemical analysis
The population of inflammatory cells will be characterized by analysis of oral mucosa samples, with emphasis on the T cell line (CD3, CD4, CD8, CD25, CD103, perforin, granzyme B and Foxp3), B cells (CD20 / CD20), dendritic cells (CD123 and CD303), submucosal dendritic cells (CD209 and factor XIIIa), Langerhans cells (CD1a and CD207), endothelial activity (e-selectin and CD31), mast cells ), macrophages (CD68 and CD163), myeloid dendritic cells (S100 and CD11c), cell proliferation markers (Ki-67, MCM-2, MCM-5, cyclin D1) and extracellular matrix (laminin-5). For immunohistochemical reactions, histological sections of 3μm thickness will be performed, which will be placed on slides coated with organosilane (Sigma-Aldrich, St Louis, MO, USA).
Measured: After 4 weeks of intensive therapy.
Venous blood collection
10 ml of venous blood to evaluate the probiotic systemic effect, by means of the research of pro-inflammatory, anti-inflammatory and regulatory cytokines.
Measured: Before (baseline) and after 4 weeks of topical therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start6 Nov 2017
- Primary completion5 Apr 2018
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Symptomatic patients presenting OLP will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol propionate 0.05%, and they will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 (experimental group) or 0.05% clobetasol propionate (control group) for mouth washing, twice a day for 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo
- Investigators
- Michel Reis Messora, DDS, PhD, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Sergio L. Souza Salvador, DDS, PhD, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Átila V. Vitor Nobre, DDS, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Cristhiam de J. Hernández Martínez, DDS, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Kleber Tanaka Suzuki, DDS, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Marina C. Gabriel Del Arco, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Lara Maria A Innocentini, DDS,PhD, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.Gilberto A Silva, MS, Study chair, University of São Paulo, Ribeirão Preto, SP, Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386643
- Sponsor's protocol ID
- CAAE: 63003716.2.0000.5419
- Status last verified
- Mar 2020
- First submitted
- 2 Dec 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data available to other researchers.
Publications
Han X, Zhang J, Tan Y, Zhou G. Probiotics: A non-conventional therapy for oral lichen planus. Arch Oral Biol. 2017 Sep;81:90-96. doi: 10.1016/j.archoralbio.2017.04.026. Epub 2017 Apr 26.
PubMed 28499235Garcia-Pola MJ, Gonzalez-Alvarez L, Garcia-Martin JM. Treatment of oral lichen planus. Systematic review and therapeutic guide. Med Clin (Barc). 2017 Oct 23;149(8):351-362. doi: 10.1016/j.medcli.2017.06.024. Epub 2017 Jul 28. English, Spanish.
PubMed 28756997Sivaraman S, Santham K, Nelson A, Laliytha B, Azhalvel P, Deepak JH. A randomized triple-blind clinical trial to compare the effectiveness of topical triamcinolone acetonate (0.1%), clobetasol propionate (0.05%), and tacrolimus orabase (0.03%) in the management of oral lichen planus. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S86-S89. doi: 10.4103/0975-7406.191976.
PubMed 27829754Ricoldi MST, Furlaneto FAC, Oliveira LFF, Teixeira GC, Pischiotini JP, Moreira ALG, Ervolino E, de Oliveira MN, Bogsan CSB, Salvador SL, Messora MR. Effects of the probiotic Bifidobacterium animalis subsp. lactis on the non-surgical treatment of periodontitis. A histomorphometric, microtomographic and immunohistochemical study in rats. PLoS One. 2017 Jun 29;12(6):e0179946. doi: 10.1371/journal.pone.0179946. eCollection 2017.
PubMed 28662142Gerhard D, Sousa FJDSS, Andraus RAC, Pardo PE, Nai GA, Neto HB, Messora MR, Maia LP. Probiotic therapy reduces inflammation and improves intestinal morphology in rats with induced oral mucositis. Braz Oral Res. 2017 Jul 3;31:e71. doi: 10.1590/1807-3107BOR-2017.vol31.0071.
PubMed 28678976
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Probiotic Bifidobacterium Animalis Subsp. Lactis HN019 on Clinical, Histopathological and Immunophenotypic Features of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT03386643
- Acronym / sponsor ID
- CAAE: 63003716.2.0000.5419
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, Probiotics, Immunomodulation.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 29 Dec 2017 (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.
Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1 to 4% of the general population, with a higher incidence in women, around the 4th and 5th decades of life. Although the pathogenesis of OLP is related to a immune-cellular response, mainly mediated by T lymphocytes, its cause remains unknown. Considering its chronic nature, control of OLP aims to reduce symptoms and improve function, and agents with anti-inflammatory action, especially topical corticosteroids result in some degree of success in most patients, depending on the clinical presentation. However, some cases are resistant to the use of corticosteroids, thus justifying the search for new therapeutic options. The immunomodulation proved to be one of the main functions of probiotic bacteria, and recent studies have shown effect of probiotics on decreasing the expression of inflammatory markers, which enables the study of this therapy as an alternative to the control of OLP. Thus, this project aims to evaluate the effects of therapy with Bifidobacterium animalis subsp. lactis HN019 comparing with clobetasol propionate 0.05% in symptomatic patients with OLP referred for diagnosis and treatment of School of Dentistry of Ribeirão Preto - University of São Paulo (USP). The impact of the topical therapy (probiotic or corticosteroid) on the clinical, histopathological and immunopathological features will be evaluated. This project was previously submitted and approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto/USP, and all patients must give informed consent to participate in this study.
Detailed description
This is a randomized double-blind clinical trial with symptomatic patients presenting OLP, which will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol propionate 0.05%. The selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 (experimental group) or 0.05% clobetasol propionate (control group) for mouth washing, twice a day for 4 weeks. Patients will be instructed to maintain normal brushing and not to use or consume another corticosteroid and /or probiotic during the study. Outcomes measures will be symptoms (VAS and Likert-like scale), quality of life (SF-36 form), and clinical changes (erythema, reticulation, erosion/ulcer based on clinical photographs), which will be performed at baseline, 15 days (only VAS, Likert-like scale and photographs) and and at one month of treatment. All patients will undergo biopsies for the diagnosis of OLP, and those who consent will be submitted to an optional biopsy at the end of the topical treatment for histopathological and immunopathological characterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Symptomatic patients presenting OLP will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol propionate 0.05%, and they will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 (experimental group) or 0.05% clobetasol propionate (control group) for mouth washing, twice a day for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium animalis subsp. lactis | Experimental | Drug: Bifidobacterium animalis subsp. lactis HN019Intervention: Bifidobacterium animalis subsp. lactis HN019 |
| Clobetasol propionate 0.05% | Active comparator | Drug: Clobetasol propionate 0.05%Intervention: Clobetasol propionate 0.05% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical inclusion
- Histopathological inclusion criteria
Key exclusion criteria (7 listed)
- Clinical exclusion criteria
- Histopathological criteria for exclusion • Presence of epithelial dysplasia, absence of the lymphocytic inflammatory infiltrate band and liquefaction degeneration.
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactis HN019Also: ProbioticThe selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 for mouthwash twice a day for 4 weeks. | Drug | Bifidobacterium animalis subsp. lactis |
| Clobetasol propionate 0.05%Also: Topical corticosteroidThe selected patients will receive capsules to be diluted in 15ml of water containing clobetasol propionate 0.05% for mouthwash twice a day for 4 weeks. | Drug | Clobetasol propionate 0.05% |
Primary outcome
Change in symptoms intensity measure
Time frame: 4 weeks
Self reported symptoms at baseline, 15 and 30 days after therapy through an visual analogue scale (VAS). It consists of a subjective scale scoring the symptoms from 0 to 10 (0 = no symptoms and 10 = as bad as can be).
3 secondary outcomes
Histopathological analysis
Time frame: Before (baseline) and one month after intensive topical therapy
Immunohistochemical analysis
Time frame: After 4 weeks of intensive therapy.
Venous blood collection
Time frame: Before (baseline) and after 4 weeks of topical therapy
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 27 Mar 2020.
- Background: PubMed 28499235Han X, Zhang J, Tan Y, Zhou G. Probiotics: A non-conventional therapy for oral lichen planus. Arch Oral Biol. 2017 Sep;81:90-96. doi: 10.1016/j.archoralbio.2017.04.026. Epub 2017 Apr 26.
- Background: PubMed 28756997Garcia-Pola MJ, Gonzalez-Alvarez L, Garcia-Martin JM. Treatment of oral lichen planus. Systematic review and therapeutic guide. Med Clin (Barc). 2017 Oct 23;149(8):351-362. doi: 10.1016/j.medcli.2017.06.024. Epub 2017 Jul 28. English, Spanish.
- Background: PubMed 27829754Sivaraman S, Santham K, Nelson A, Laliytha B, Azhalvel P, Deepak JH. A randomized triple-blind clinical trial to compare the effectiveness of topical triamcinolone acetonate (0.1%), clobetasol propionate (0.05%), and tacrolimus orabase (0.03%) in the management of oral lichen planus. J Pharm Bioallied Sci. 2016 Oct;8(Suppl 1):S86-S89. doi: 10.4103/0975-7406.191976.
- Background: PubMed 28662142Ricoldi MST, Furlaneto FAC, Oliveira LFF, Teixeira GC, Pischiotini JP, Moreira ALG, Ervolino E, de Oliveira MN, Bogsan CSB, Salvador SL, Messora MR. Effects of the probiotic Bifidobacterium animalis subsp. lactis on the non-surgical treatment of periodontitis. A histomorphometric, microtomographic and immunohistochemical study in rats. PLoS One. 2017 Jun 29;12(6):e0179946. doi: 10.1371/journal.pone.0179946. eCollection 2017.
- Background: PubMed 28678976Gerhard D, Sousa FJDSS, Andraus RAC, Pardo PE, Nai GA, Neto HB, Messora MR, Maia LP. Probiotic therapy reduces inflammation and improves intestinal morphology in rats with induced oral mucositis. Braz Oral Res. 2017 Jul 3;31:e71. doi: 10.1590/1807-3107BOR-2017.vol31.0071.
- Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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.
Michel Reis Messora, DDS, PhD study chair
University of São Paulo, Ribeirão Preto, SP, Brazil.
Sergio L. Souza Salvador, DDS, PhD study chair
University of São Paulo, Ribeirão Preto, SP, Brazil.
Átila V. Vitor Nobre, DDS study chair
University of São Paulo, Ribeirão Preto, SP, Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bifidobacterium animalis subsp. lactis HN019 and Clobetasol propionate 0.05% in people with Oral Lichen Planus, run by University of Sao Paulo at 1 site in Brazil.
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 7 inclusion and 7 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 27 Mar 2020. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 symptoms intensity measure (time frame: 4 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 NCT03386643, which also lists 5 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 27 Mar 2020.