Immune Mediated Inflammatory DiseasesPhase 1NCT05003089
A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row in Healthy Male Participants
A Phase 1 study testing BAY1834845, BAY1830839 and Prednisolone in people with Immune Mediated Inflammatory Diseases, run by Bayer at 1 site in Netherlands.
Trial summary
The immune system helps protect the body from diseases. But, sometimes the immune system can be too sensitive and overreact to very small allergens, like dust and pet dander. This can cause skin conditions like dermatitis and eczema. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Mediated Inflammatory Diseases
- What is being tested?
- BAY1834845, BAY1830839 and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jun 2021to 20 Jan 2022
- Phase
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Overtly healthy as determined by medical evaluation including medical and surgical history, physical examination, laboratory tests, ECG and vital signs.
- Participant has Fitzpatrick skin phototypes I (very fair), II (fair), or III (darker white skin).
- Body weight must be above 50 kg and body mass index (BMI) above or equal 18.5 and lower or equal 28 kg/m2 at the screening visit.
- Male.
Who cannot join
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator
- A history of relevant diseases of vital organs, of the central nervous system including neuropsychiatric illness or other organs, previous syncope or autoimmune disease such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune-inflammatory diseases.
- Unintended weight loss or gain of at least 5 kg in 4 weeks at screening.
- Any serious concomitant illness that anticipates the need of systemic medication interfering with the study medication.
- A history of trauma with likely damage to the spleen, surgery to spleen or congenital abnormalities of the spleen.
- Hemorrhagic diathesis (easy bruising, epistaxis, gastro-intestinal bleeding).
Show all 30Show fewer
- History of known pulmonary embolism or known anti-phospholipid syndrome.
- Previous participation in a systemic (i.v./inhalative) lipopolysaccharide (LPS) challenge trial within one year before start of treatment.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal (cholecystectomy permitted).
- Any infection requiring hospitalization, systemic antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months prior to treatment period.
- Any active or ongoing chronic infectious disease including periodontitis with the exception of common viral or fungal skin infections such as plantar warts or athlete's foot.
- Febrile illness within 30 days before the start of the first study intervention.
- Medical history of sepsis, tuberculosis, increased frequency of infections, immunodeficiency diseases, with recent febrile diseases and anamnestic and/or laboratory signs of an impaired immune status or latent infections (hepatitis B, hepatitis C, and human immunodeficiency virus [HIV]).
- History of COVID-19 within 6 months prior to treatment period or in case of clinically relevant sequela of former COVID-19 (such as fatigue or exercise dyspnea)
- Contact with SARS-CoV-2- positive or COVID-19 patient within the last 2 weeks prior to SARS-CoV-2 viral PCR test (at visit 2).
- History of major surgery within 8 weeks prior to treatment period or scheduled (elective) surgery, planned hospitalization and surgical dental treatment within study and 4 weeks after final follow-up.
- History of or acute atopic dermatitis with active eczematous lesions, bronchial asthma or allergic rhino-conjunctivitis symptomatic during screening period.
- History of other concomitant skin conditions (chronic inflammatory dermatoses) that would interfere with the evaluation of the effect of the study medication on contact dermatitis.
- History of hypersensitivity to any of the components of the study interventions.
- History of malignant tumors (except treated basal cell carcinoma).
- Any clinical contraindications to treatment with steroids, such as uncontrolled hypertension, chronic liver disease (Child-Pugh scores B or C), latent diabetes mellitus, history of gastrointestinal bleeding.
- Use of topical and systemic drugs (prescription or over-the-counter [OTC]) within 30 days or within 5 half-lives (whichever is longer) before start of treatment.
- Use of other investigational drugs within 30 days or within 5 halflives (whichever is longer) of the investigational product before screening.
- Receipt of live or attenuated vaccine (with the exception of adenovirus-vectored SARS-CoV-2 vaccinations) 90 days before start of treatment.
- Vaccination completion (completion of 2nd vaccination shot if applicable) against SARS-CoV-2 or influenza vaccinations less than 15 days prior to first study drug administration. (Vaccines with a single-dose scheme: Receipt of vaccination < 29 days before the planned first administration of the study intervention).
- Phototherapy and extensive sun/ ultraviolet (UV) exposure within 4 weeks prior screening and throughout study.
- Clinically relevant findings in the ECG, blood pressure and pulse rate, which in the opinion of the investigator(s), may put the participant at risk because of his participation in the trial
- Clinically relevant findings in the physical examination, especially skin abnormalities in the application area.
- Clinically relevant deviations of the laboratory parameters from reference ranges at screening, ALT>1.1 x ULN, AST>1.2 x ULN, total bilirubin > ULN, CRP>5 mg/L (above ULN or clinical or laboratory signs of infection) or other clinically relevant laboratory abnormalities.
- Whole blood or red blood cell donation, or any blood loss > 500 mL within 3 months prior to screening or donation of plasma within 14 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Partial-blind, Parallel-group Study Evaluating the Effect of Oral Administration of BAY 1834845 and BAY 1830839 Twice Daily for 7 Consecutive Days on Local and Systemic IRAK4 Pathway-related Challenges in Healthy Male Participants
The immune system helps protect the body from diseases. But, sometimes the immune system can be too sensitive and overreact to very small allergens, like dust and pet dander. This can cause skin conditions like dermatitis and eczema. People with these skin conditions have inflammation that can cause dry, red, and itchy skin. These symptoms often "flare up", meaning that the symptoms come back after being gone for some time.
Researchers are looking for a different way to treat people who have skin conditions caused by an overreaction of the immune system. Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works.
Read more
In this trial, the researchers will learn more about how BAY1834845 and BAY1830839 work and how safe they are in healthy male participants.
The trial will include about 72 healthy male participants who are between the ages of 18 and 55.
The researchers will use a computer program to randomly choose the treatment each participant will take. This will help make sure the treatments are chosen fairly. Researchers do this so that comparing the results of the treatments is accurate as possible. The participants will be randomly put into 1 of 4 groups. The participants will take their trial treatment 2 times a day for 7 days in a row.
- Group 1: BAY1834845 as tablets by mouth
- Group 2: BAY1830839 as tablets by mouth
- Group 3: A placebo as tablets by mouth
- Group 4: Prednisolone as tablets by mouth A placebo looks like a treatment but does not have any medicine in it. Prednisolone is a steroid treatment that is already available for doctors to prescribe to people with skin conditions caused by an overreaction of the immune system.
All the participants will also receive imiquimod applied as a cream to their back. All participants will also receive lipopolysaccharide as an intravenous infusion. Imiquimod and lipopolysaccharide will be used to cause irritation and inflammation of the skin and in the blood. The researchers want to see if treatment with BAY1834845 and BAY1830939 can then help reduce these symptoms of irritation and inflammation.
In this trial, the researchers will look at:
- the change in the amount of blood flow in the participants after imiquimod
- the change in how red the participants' skin is after imiquimod
- the change in the amount of inflammation applying the participants have after receiving lipopolysaccharide infusion
- Conditions
- Immune Mediated Inflammatory Diseases
- Being tested
- BAY1834845, BAY1830839, Prednisolone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1834845Drug
Tablet, oral.
BAY1830839Drug
Tablet, oral.
PrednisoloneDrug
Tablet, oral.
PlaceboDrug
Tablet, oral.
| Study group | Role | What they receive |
|---|---|---|
| BAY1834845 arm | Experimental | BAY1834845 will be administered twice daily for 7 consecutive days (Days 1 - 7). Receives: Drug: BAY1834845 |
| BAY1830839 arm | Experimental | BAY1830839 will be administered twice daily for 7 consecutive days (Days 1 - 7). Receives: Drug: BAY1830839 |
| Prednisolone arm | Active comparator | Prednisolone will be administered twice daily for 7 consecutive days (Days 1 - 7). Receives: Drug: Prednisolone |
| Placebo arm | Placebo comparator | Placebo will be administered twice daily for 7 consecutive days (Days 1 - 7). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change of perfusion/basal flow
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments
Measured: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Average change of erythema score
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments. Erythema score will be measured by Antera 3D camera.
Measured: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Average change in TNF-α
Measured: From pre-challenge up to 6 hour after the systemic challenge
Average change in IL-6
Measured: From pre-challenge up to 6 hour after the systemic challenge
Secondary outcomes (13)
Change of perfusion/basal flow
Measured: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Change of erythema score
Erythema score will be measured by Antera 3D camera.
Measured: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Average change of Clinician Erythema Assessment (CEA) score
Clinician Erythema Assessment (CEA) scale:
0 - Clear skin with no signs of erythema; 1 - Almost clear, slight redness; 2 - Mild erythema, defined redness; 3 - Moderate erythema, marked redness; 4 - Severe erythema, fiery redness.
Measured: Pre-challenge and at 24 hour / 48 hour / 72 hour after first administration of skin challenge
Changes in cytokines cells of skin suction blisters
Skin suction blisters will be induced on the tape stripping and/or treated skin areas, allowing the collection of blister exudate for cytokine cell analysis.
Measured: From baseline up to 72 hour after first administration of skin challenge
Changes in immune cells of skin suction blisters
Skin suction blisters will be induced on the tape stripping and/or treated skin areas, allowing the collection of blister exudate for immune cell analysis.
Measured: From baseline up to 72 hour after first administration of skin challenge
Changes in immune cells of blood samples
Measured: From pre-challenge up to 24 hour after systemic challenge
Changes in C-reactive protein (CRP) of blood samples
Measured: From pre-challenge up to 24 hour after systemic challenge
Changes in Procalcitonin (PCT) of blood samples
Measured: From pre-challenge up to 24 hour after systemic challenge
Changes in other inflammation markers of blood samples
Measured: From pre-challenge up to 24 hour after systemic challenge
Changes in temperature
Measured: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in pulse rate
Measured: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in systolic blood pressure
Measured: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in diastolic blood pressure
Measured: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start28 Jun 2021
- Primary completion16 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Mediated Inflammatory DiseasesStudies of the same condition, open and under way.
- More trials run by BayerThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003089
- Sponsor's protocol ID
- 21329
- Other IDs
- 2020-003138-18
- Status last verified
- Dec 2022
- First submitted
- 16 Jul 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Partial-blind, Parallel-group Study Evaluating the Effect of Oral Administration of BAY 1834845 and BAY 1830839 Twice Daily for 7 Consecutive Days on Local and Systemic IRAK4 Pathway-related Challenges in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05003089
- Acronym / sponsor ID
- 21329
- Conditions
- Immune Mediated Inflammatory Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 12 Aug 2021 (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 immune system helps protect the body from diseases. But, sometimes the immune system can be too sensitive and overreact to very small allergens, like dust and pet dander. This can cause skin conditions like dermatitis and eczema. People with these skin conditions have inflammation that can cause dry, red, and itchy skin. These symptoms often "flare up", meaning that the symptoms come back after being gone for some time.
Researchers are looking for a different way to treat people who have skin conditions caused by an overreaction of the immune system. Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works.
In this trial, the researchers will learn more about how BAY1834845 and BAY1830839 work and how safe they are in healthy male participants.
The trial will include about 72 healthy male participants who are between the ages of 18 and 55.
The researchers will use a computer program to randomly choose the treatment each participant will take. This will help make sure the treatments are chosen fairly. Researchers do this so that comparing the results of the treatments is accurate as possible. The participants will be randomly put into 1 of 4 groups. The participants will take their trial treatment 2 times a day for 7 days in a row.
- Group 1: BAY1834845 as tablets by mouth
- Group 2: BAY1830839 as tablets by mouth
- Group 3: A placebo as tablets by mouth
- Group 4: Prednisolone as tablets by mouth A placebo looks like a treatment but does not have any medicine in it. Prednisolone is a steroid treatment that is already available for doctors to prescribe to people with skin conditions caused by an overreaction of the immune system.
All the participants will also receive imiquimod applied as a cream to their back. All participants will also receive lipopolysaccharide as an intravenous infusion. Imiquimod and lipopolysaccharide will be used to cause irritation and inflammation of the skin and in the blood. The researchers want to see if treatment with BAY1834845 and BAY1830939 can then help reduce these symptoms of irritation and inflammation.
In this trial, the researchers will look at:
- the change in the amount of blood flow in the participants after imiquimod
- the change in how red the participants' skin is after imiquimod
- the change in the amount of inflammation applying the participants have after receiving lipopolysaccharide infusion
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY1834845 arm | Experimental | Drug: BAY1834845BAY1834845 will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| BAY1830839 arm | Experimental | Drug: BAY1830839BAY1830839 will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| Prednisolone arm | Active comparator | Drug: PrednisolonePrednisolone will be administered twice daily for 7 consecutive days (Days 1 - 7). |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo will be administered twice daily for 7 consecutive days (Days 1 - 7). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Overtly healthy as determined by medical evaluation including medical and surgical history, physical examination, laboratory tests, ECG and vital signs.
- Participant has Fitzpatrick skin phototypes I (very fair), II (fair), or III (darker white skin).
- Body weight must be above 50 kg and body mass index (BMI) above or equal 18.5 and lower or equal 28 kg/m2 at the screening visit.
- Male.
Key exclusion criteria (30 listed)
- Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator
- A history of relevant diseases of vital organs, of the central nervous system including neuropsychiatric illness or other organs, previous syncope or autoimmune disease such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune-inflammatory diseases.
- Unintended weight loss or gain of at least 5 kg in 4 weeks at screening.
- Any serious concomitant illness that anticipates the need of systemic medication interfering with the study medication.
- A history of trauma with likely damage to the spleen, surgery to spleen or congenital abnormalities of the spleen.
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 |
|---|---|---|
| BAY1834845Tablet, oral. | Drug | BAY1834845 arm |
| BAY1830839Tablet, oral. | Drug | BAY1830839 arm |
| PrednisoloneTablet, oral. | Drug | Prednisolone arm |
| PlaceboTablet, oral. | Drug | Placebo arm |
Primary outcome
Average change of perfusion/basal flow
Time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments
Average change of erythema score
Time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
The change from baseline will be averaged over the changes at 24 hour / 48 hour / 72 hour assessments. Erythema score will be measured by Antera 3D camera.
Average change in TNF-α
Time frame: From pre-challenge up to 6 hour after the systemic challenge
Average change in IL-6
Time frame: From pre-challenge up to 6 hour after the systemic challenge
13 secondary outcomes
Change of perfusion/basal flow
Time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Change of erythema score
Time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge
Average change of Clinician Erythema Assessment (CEA) score
Time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after first administration of skin challenge
Changes in cytokines cells of skin suction blisters
Time frame: From baseline up to 72 hour after first administration of skin challenge
Changes in immune cells of skin suction blisters
Time frame: From baseline up to 72 hour after first administration of skin challenge
Changes in immune cells of blood samples
Time frame: From pre-challenge up to 24 hour after systemic challenge
Changes in C-reactive protein (CRP) of blood samples
Time frame: From pre-challenge up to 24 hour after systemic challenge
Changes in Procalcitonin (PCT) of blood samples
Time frame: From pre-challenge up to 24 hour after systemic challenge
Changes in other inflammation markers of blood samples
Time frame: From pre-challenge up to 24 hour after systemic challenge
Changes in temperature
Time frame: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in pulse rate
Time frame: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in systolic blood pressure
Time frame: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
Changes in diastolic blood pressure
Time frame: From pre-challenge to 0.5 hour / 1 hour / 2 hour / 4 hour / 6 hour and 8 hour after systemic challenge
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 Dec 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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?
A Phase 1 study testing BAY1834845, BAY1830839 and Prednisolone in people with Immune Mediated Inflammatory Diseases, run by Bayer at 1 site in Netherlands.
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 5 inclusion and 30 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 Dec 2022. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Average change of perfusion/basal flow (time frame: Pre-challenge and at 24 hour / 48 hour / 72 hour after start of skin challenge). The study lists 4 primary outcomes in all. 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 16 Dec 2022.