Atopic DermatitisPhase 2NCT05491447
A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis
A Phase 2 study testing BMX-010 in people with Atopic Dermatitis, run by BioMimetix JV, LLC at 19 sites in United States.
Trial summary
Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BMX-010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 19 sitesUnited States
- Study dates
- 8 Jan 2023to 15 Apr 2024
- 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
- Male or female, at least 18 years of age at the time of consent;
- Diagnosis of AD, as defined by the criteria of Hanifin and Rajka, stable in the last 4 weeks, with onset at least 6 months prior to screening (information obtained from medical chart or subject's physician, or directly from the subject).
- Group 1 only: Subjects should have AD covering approximately 2-5% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds). Subjects will treat approximately 5% of their BSA (excluding scalp, face palms, soles, genitals, and folds).
- Group 2 only: 4. Group 2 only: Subject has active AD lesions covering 2-25% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds from BSA calculation).
- EASI score >/= 5 (greater than or equal to 5) at screening and Day 1.
- vIGA-AD score ≥ 2 (greater than or equal to 2) at screening and Day 1.
Show all 12Show fewer
- Candidate for topical treatment of AD;
- Subjects must be willing to apply an emollient of their choice during study.
- Females of child-bearing potential must have a negative urine pregnancy test at screening and on the day of the first drug administration;
- Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study.
- Ability to complete the study in compliance with the protocol, including agreement in writing to apply IP only to the assigned areas.
- Ability to understand and provide written informed consent.
Who cannot join
- Subjects with AD only located on the hands and feet.
- Subjects with clinically infected AD.
- Subjects for which systemic pharmacotherapy or phototherapy for the treatment of AD is indicated or required.
- Treatment with systemic retinoids, corticosteroids, immunomodulators or immunosuppressive agents (e.g., methotrexate, cyclosporine), cytotoxic agents, interferon, upadacitinib, abrocitinib, or baricitinib within 4 weeks of the Baseline visit or anticipated need for any of these therapies during the study period.
- Treatment with topical corticosteroids, crisaborole, ruxolitinib, Vitamin D analogs, keratolytics, coal tar, calcineurin inhibitors, antihistamines or any other therapeutic agents besides bland emollients within 2 weeks of the Baseline visit or anticipated need for any of these.
- Treatment with a biological agent (such as a monoclonal antibody) within a period of time of 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
Show all 26Show fewer
- Subject has used systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Day 1. Of note, subjects with herpes labialis or genitalis and use of antivirals for these diseases are allowed.
- Subject has used dupilumab within 26 weeks prior to Day 1.
- Subject has used doxepin within 1 week prior to Day 1.
- Subject has used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
- Subject has used topical products containing urea within 1 week prior to Day 1.
- Subject has used medical devices, and bleach baths within 2 weeks prior to Day 1.
- Subject has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (except on treated lesions) and protective apparel are recommended when sun exposure cannot be avoided.
- Subject has received an intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Day 1.
- AD triggered by an unavoidable environmental allergen or irritant.
- Contact dermatitis or drug-induced skin reactions.
- Concomitant skin disease that could confound clinical evaluations or increase risk to the subject.
- Systemic or skin infection requiring antimicrobial therapy within 14 days prior to Baseline.
- Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit.
- Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome, including patients receiving immune therapy.
- Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator.
- Active drug or alcohol dependence.
- Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study; clinically significant renal or hepatic insufficiency.
- History of malignancy, unless clinically cured for more than 5 years prior to Baseline. This exclusion does not apply to basal and squamous cell carcinomas of skin and carcinoma in situ of the cervix if they have been adequately treated and are clinically judged to be cured.
- Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participation in another investigational drug or vaccine trial concurrently or within 4 weeks for nonbiological investigational products or devices or 12 weeks (or 5 half-lives) for biological investigational products prior to Screening visit.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, 35244
Skin Care Research
Boca Raton, Florida, 33486
Dermatology Trial Associates
Bryant, Arkansas, 72022
J&S Studies, Inc.
College Station, Texas, 77845
Driven Research LLC
Coral Gables, Florida, 33134
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Colorado Skin Care
Englewood, Colorado, 80113
Johnson Dermatology
Fort Smith, Arkansas, 72916
Axon Clinical Research
Inglewood, California, 90301
Skin Sciences, Pllc
Louisville, Kentucky, 40241
Clinical Trials Management, LLC
Mandeville, Louisiana, 70448
RM Medical Research
Miami Lakes, Florida, 33014
National Allergy and Asthma Research, LLC.
North Charleston, South Carolina, 29420
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Dermatology Specialists of Spokane (Dermatology Specialists of Spokane, PLLC)
Spokane, Washington, 99202
Lenus Research
Sweetwater, Florida, 33172
Revival Research Institute, LLC
Troy, Michigan, 48084
Physicians Research Group
West Lafayette, Indiana, 47906
About this study
Official title: A Phase 2 Clinical Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 Ointment in Adult Subjects With Atopic Dermatitis
Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.
Read the detailed description
Group 1 is an open-label safety cohort to determine the PK profile of the active study drug, BMX-010 ointment. At least 3 and up to 12 subjects will be enrolled to analyze the safety and pharmacokinetics of BMX-010 ointment. If a subject cannot complete the required PK blood draws, another subject will be enrolled to ensure at least 3 subjects complete the PK blood draws. Subjects will not be randomized and all subjects in this group will be dispensed BMX-010. Dispensing information will be provided by IWRS. Study drug will be administered in clinic on Day 1 and also Day 8 (the first study drug application of the day) in order to obtain pre-dose PK blood draws. Once a minimum of 3 subjects complete all of the PK blood draws (through Day 8) and the data is analyzed, the Clinical Safety Committee (CSC) will review and determine if enrollment to Group 2 can begin.
Enrollment of subjects into Group 2 will not begin until the PK and safety data from a minimum of three subjects enrolled in Group 1 is obtained and analyzed, and proceeding with Group 2 has been approved by the sponsor.
Once enrollment in Group 2 begins, the subjects will be randomized into Arm A, B, or C.
Group 2 is a randomized, partially blinded (where neither the subjects nor the appropriate clinical center staff are told which treatment or intervention participants are receiving), placebo-controlled cohort designed to further test the safety and efficacy of BMX-010 ointment vs. placebo. Up to approximately 216 adult subjects with AD will be enrolled. At the baseline visit, subjects will be randomized to receive BMX-010 (0.5% or 0.1%) or placebo in a 1:1:1 ratio, by a permuted block randomization schema.
- Conditions
- Atopic Dermatitis
- Being tested
- BMX-010, Placebo
- Keywords
- AD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMX-010Drug
Ointment
PlaceboDrug
Ointment
| Study group | Role | What they receive |
|---|---|---|
| Study Drug Treated, BMX-010 0.5% | Active comparator | n=72 Receives: Drug: BMX-010 |
| Study Drug Treated, BMX-010 0.1% | Active comparator | n=72 Receives: Drug: BMX-010 |
| Placebo Treated | Placebo comparator | n=72 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Eczema Area and Severity Index at Week 4
Evaluate the change in Eczema Area and Severity Index score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle from baseline to week 4.
Measured: 28 days
Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters
Compare treatment emergent adverse events, as well as changes from baseline in vital signs and clinical laboratory parameters in subjects with active AD receiving BMX-010 0.5% and 0.1% ointment compared with vehicle.
Measured: 28 days
Secondary outcomes (9)
Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.
Evaluate the change in Eczema Area and Severity Index score subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, and 3.
Measured: 21 days
Proportion of subjects who achieve Eczema Area and Severity Index-50 and Eczema Area and Severity Index -75 at Weeks 1, 2, 3 and 4.
Eczema Area and Severity Index-50 and Eczema Area and Severity Index-75 measures indicate the proportion of subjects with active AD with improvement over 50% and 75% based on the Eczema Area and Severity Index at weeks 1, 2, 3, and 4 in subjects treating with BMX-010 0.5% and BMX-010 0.1% compared to vehicle .
Measured: 28 days
Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4
Evaluate the change in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scores in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Measured: 28 days
Change from baseline in body surface area at Weeks 1, 2, 3, and 4.
Evaluate the change in Body Surface Area in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Measured: 28 days
Change from baseline in validated Investigator Global Assessment of Atopic Dermatitis at Weeks 1, 2, 3, and 4.
Evaluate the change in validated Investigator Global Assessment of Atopic Dermatitis score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Measured: 28 days
Proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4.
Evaluate the proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle at weeks 1, 2, 3 and 4.
Measured: 28 days
Change from baseline in the Pruritus Numerical Rating Scale (NRS) at Weeks 1, 2, 3, and 4.
Evaluate the change in the Pruritus Numerical Rating Scale score from baseline to weeks 1, 2, 3, and 4 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle.
Measured: 28 days
Change from baseline in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) on Day 1.
Evaluate the change in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) compared to the pre-dose value on Day 1 in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle.
Measured: 1 day
Measurement of plasma concentrations of BMX-010 in participants receiving active treatment
Pharmacokinetic plasma samples will be collected on Day 1 and Day 8 at pre-dose and 1 and 3 hours post dose to evaluate the systemic exposure profile and pharmacokinetic (PK) behavior of BMX-010 under the conditions of this trial.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start8 Jan 2023
- Primary completion30 Dec 2023
- Study completion15 Apr 2024
Why it stopped: Funding constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Group 1, Group 2
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetix JV, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491447
- Sponsor's protocol ID
- BMX-DERM-02
- Status last verified
- Apr 2024
- First submitted
- 3 Aug 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 Ointment in Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05491447
- Acronym / sponsor ID
- BMX-DERM-02
- Conditions
- Atopic Dermatitis
- Keywords
- AD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding constraints
- Enrolment
- 103 participants (actual)
- Lead sponsor
- BioMimetix JV, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 8 Aug 2022 (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.
Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.
Detailed description
Group 1 is an open-label safety cohort to determine the PK profile of the active study drug, BMX-010 ointment. At least 3 and up to 12 subjects will be enrolled to analyze the safety and pharmacokinetics of BMX-010 ointment. If a subject cannot complete the required PK blood draws, another subject will be enrolled to ensure at least 3 subjects complete the PK blood draws. Subjects will not be randomized and all subjects in this group will be dispensed BMX-010. Dispensing information will be provided by IWRS. Study drug will be administered in clinic on Day 1 and also Day 8 (the first study drug application of the day) in order to obtain pre-dose PK blood draws. Once a minimum of 3 subjects complete all of the PK blood draws (through Day 8) and the data is analyzed, the Clinical Safety Committee (CSC) will review and determine if enrollment to Group 2 can begin.
Enrollment of subjects into Group 2 will not begin until the PK and safety data from a minimum of three subjects enrolled in Group 1 is obtained and analyzed, and proceeding with Group 2 has been approved by the sponsor.
Once enrollment in Group 2 begins, the subjects will be randomized into Arm A, B, or C.
Group 2 is a randomized, partially blinded (where neither the subjects nor the appropriate clinical center staff are told which treatment or intervention participants are receiving), placebo-controlled cohort designed to further test the safety and efficacy of BMX-010 ointment vs. placebo. Up to approximately 216 adult subjects with AD will be enrolled. At the baseline visit, subjects will be randomized to receive BMX-010 (0.5% or 0.1%) or placebo in a 1:1:1 ratio, by a permuted block randomization schema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1, Group 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug Treated, BMX-010 0.5% | Active comparator | Drug: BMX-010n=72 |
| Study Drug Treated, BMX-010 0.1% | Active comparator | Drug: BMX-010n=72 |
| Placebo Treated | Placebo comparator | Drug: Placebon=72 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, at least 18 years of age at the time of consent;
- Diagnosis of AD, as defined by the criteria of Hanifin and Rajka, stable in the last 4 weeks, with onset at least 6 months prior to screening (information obtained from medical chart or subject's physician, or directly from the subject).
- Group 1 only: Subjects should have AD covering approximately 2-5% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds). Subjects will treat approximately 5% of their BSA (excluding scalp, face palms, soles, genitals, and folds).
- Group 2 only: 4. Group 2 only: Subject has active AD lesions covering 2-25% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds from BSA calculation).
- EASI score >/= 5 (greater than or equal to 5) at screening and Day 1.
Key exclusion criteria (26 listed)
- Subjects with AD only located on the hands and feet.
- Subjects with clinically infected AD.
- Subjects for which systemic pharmacotherapy or phototherapy for the treatment of AD is indicated or required.
- Treatment with systemic retinoids, corticosteroids, immunomodulators or immunosuppressive agents (e.g., methotrexate, cyclosporine), cytotoxic agents, interferon, upadacitinib, abrocitinib, or baricitinib within 4 weeks of the Baseline visit or anticipated need for any of these therapies during the study period.
- Treatment with topical corticosteroids, crisaborole, ruxolitinib, Vitamin D analogs, keratolytics, coal tar, calcineurin inhibitors, antihistamines or any other therapeutic agents besides bland emollients within 2 weeks of the Baseline visit or anticipated need for any of these.
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 |
|---|---|---|
| BMX-010Ointment | Drug | Study Drug Treated, BMX-010 0.1%, Study Drug Treated, BMX-010 0.5% |
| PlaceboOintment | Drug | Placebo Treated |
Primary outcome
Change from Baseline in Eczema Area and Severity Index at Week 4
Time frame: 28 days
Evaluate the change in Eczema Area and Severity Index score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle from baseline to week 4.
Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters
Time frame: 28 days
Compare treatment emergent adverse events, as well as changes from baseline in vital signs and clinical laboratory parameters in subjects with active AD receiving BMX-010 0.5% and 0.1% ointment compared with vehicle.
9 secondary outcomes
Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.
Time frame: 21 days
Proportion of subjects who achieve Eczema Area and Severity Index-50 and Eczema Area and Severity Index -75 at Weeks 1, 2, 3 and 4.
Time frame: 28 days
Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4
Time frame: 28 days
Change from baseline in body surface area at Weeks 1, 2, 3, and 4.
Time frame: 28 days
Change from baseline in validated Investigator Global Assessment of Atopic Dermatitis at Weeks 1, 2, 3, and 4.
Time frame: 28 days
Proportion of subjects who achieve a validated Investigator Global Assessment of Atopic Dermatitis score of Almost clear (1) and/or Clear (0) with a 2-point reduction at Weeks 1, 2, 3, and 4.
Time frame: 28 days
Change from baseline in the Pruritus Numerical Rating Scale (NRS) at Weeks 1, 2, 3, and 4.
Time frame: 28 days
Change from baseline in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) on Day 1.
Time frame: 1 day
Measurement of plasma concentrations of BMX-010 in participants receiving active treatment
Time frame: 8 days
Results and safety
The study was stopped early (reason given: Funding constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMX-010 in people with Atopic Dermatitis, run by BioMimetix JV, LLC at 19 sites in United States.
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 12 inclusion and 26 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: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 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 was stopped early (reason given: Funding constraints). Results are not available in the source record.
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 from Baseline in Eczema Area and Severity Index at Week 4 (time frame: 28 days). The study lists 2 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 18 Apr 2024.