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Study Summary
This trial tests a product for AD: Subjects get 2 doses/day for 28 days, weekly visits to check progress, followed by a final visit 2 weeks later. Clinical assessors will be blind.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a weakened immune system, HIV, or AIDS.I have used dupilumab within the last 6 months.I haven't used systemic antibiotics in the last 2 weeks or topical antibiotics in the last week, except for herpes treatment.I have had IVIg therapy in the last 12 weeks.You have allergic dermatitis caused by something in your environment that cannot be avoided.I haven't taken antibiotics for an infection in the last 14 days.I am willing to use two forms of birth control during and for a month after the trial.I do not have any major health issues that could make this study unsafe for me.My eczema is only on my hands and feet.I haven't used specific skin treatments like steroids or antihistamines in the last 2 weeks.I have not been in a drug or vaccine study within the last 4 to 12 weeks.I haven't taken any biological treatments like monoclonal antibodies for the longer of 12 weeks or 5 half-lives before Day 1.I have eczema affecting 2-5% of my body, not including sensitive areas.I have been exposed to a lot of sun recently or plan to be, and can't avoid it during the study.I am willing to use a moisturizer of my choice during the study.I have been diagnosed with atopic dermatitis for at least 6 months and it has been stable for the last 4 weeks.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I haven't taken strong immune or cancer drugs in the last 4 weeks.I am a woman who can have children and have tested negative for pregnancy.I am 18 years old or older.I am a candidate for cream or ointment treatment for my skin condition.You have skin reactions caused by contact with certain substances or medications.I have a clinically confirmed infection in my atopic dermatitis.I need medication or light therapy for my skin condition.I have taken doxepin in the last week.I have active eczema covering 2-25% of my body, not including my scalp, face, hands, feet, genitals, or folds.I have taken hydroxyzine or diphenhydramine in the last week.I do not have a skin condition that could affect study results or increase my risk.I have used skin products with urea in the last week.You are currently dependent on drugs or alcohol.I had major surgery less than 8 weeks ago or have one planned soon.I have been cancer-free for over 5 years, except for certain skin cancers and cervical pre-cancers that were treated.
- Group 1: Study Drug Treated, BMX-010 0.5%
- Group 2: Study Drug Treated, BMX-010 0.1%
- Group 3: Placebo Treated
- Screening: It may take up to 31 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 28 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 15 Months after you stop receiving the treatment.
Frequently Asked Questions
What objectives is the trial attempting to fulfill?
"This 28-day trial seeks to analyse the prevalence of treatment related adverse events, alterations in vital signs and laboratory parameters. Secondary objectives include determining the proportion of subjects achieving Eczema Area and Severity Index (EASI) 50% or 75% improvement at weeks 1, 2, 3 & 4 when using BMX-010 0.5 %/0.1%, changes from baseline EASI scores at weeks 1,2 &3; as well as Body Surface Area x validated Investigator Global Assessment of Atopic dermatitis score modification at week intervals up until Week 4 for those receiving BMX-010 0.5 %"
Has the FDA sanctioned BMX-010 0.1% for medical use?
"The safety of BMX-010 0.1%, as evaluated by Power's team, was ranked 2 due to the lack of clinical data and efficacy concerning this Phase 2 trial."
In which geographical regions can participants access this research trial?
"Lenus Research in Sweetwater, Utah, Jordan Valley Dermatology Center in South Jordan, Indiana, and Physicians Research Group in West Lafayette, Texas are three of the sites currently enlisting patients for this trial. Additionally, there are 5 other locations recruiting participants as well."
Are any fresh participants being sought for this trial?
"Herein, the trial is still on the lookout for participants. According to clinicaltrials.gov, it was first posted on November 8th 2022 and the most recent amendment occurred 6 days later."
What is the enrollment count for this exploration?
"Affirmative. According to the information provided on clinicaltrials.gov, this trial is currently seeking recruits with its initial posting date being 8th November 2022 and latest edit taking place 16th November of the same year. For successful completion, 224 participants need to be recruited from 5 medical sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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