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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Timeline
Screening 31 days
Treatment Varies
Follow Up 15 days
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.
Who is the study for?
Adults at least 18 years old with stable Atopic Dermatitis (AD) covering 2-25% of their body, excluding certain areas. They must have an EASI score of ≥5 and a vIGA-AD score of ≥2. Women must use two contraception methods during the trial and one month after. Participants cannot have AD only on hands/feet, used certain treatments recently, or be pregnant.
What is being tested?
The trial is testing BMX-010 applied twice daily for 28 days against a placebo in adults with Atopic Dermatitis. It's blinded so neither participants nor assessors know who gets the real treatment. The study checks how the drug moves in the body and its effectiveness.
What are the potential side effects?
Potential side effects are not specified here but generally could include skin irritation, redness, itching or worsening of dermatitis symptoms due to either BMX-010 or placebo application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with atopic dermatitis for at least 6 months and it has been stable for the last 4 weeks.
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I have eczema affecting 2-5% of my body, not including sensitive areas.
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I am a candidate for cream or ointment treatment for my skin condition.
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I am willing to use a moisturizer of my choice during the study.
Timeline
Screening ~ 31 days1 visit
Treatment ~ Varies
Follow Up ~ 15 days1 visit
Screening ~ 31 days
Treatment ~ Varies
Follow Up ~15 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Eczema Area and Severity Index at Week 4
Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters
Secondary study objectives
Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4
Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.
Change from baseline in Modified Pruritus Numerical Rating Scale (Current Itch Intensity; 30 minutes and 4 hours post-dose) on Day 1.
+6 moreOther study objectives
Change and percent change from baseline of subject-reported Patient-Oriented Eczema Measure (POEM) scores to Week 4.
Change from baseline in answers on the subject reported PRO questions regarding itching at Weeks 1, 2, 3 and 4
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Study Drug Treated, BMX-010 0.5%Active Control1 Intervention
n=72
Group II: Study Drug Treated, BMX-010 0.1%Active Control1 Intervention
n=72
Group III: Placebo TreatedPlacebo Group1 Intervention
n=72
Find a Location
Who is running the clinical trial?
Innovaderm Research Inc.OTHER
48 Previous Clinical Trials
3,117 Total Patients Enrolled
BioMimetix JV, LLCLead Sponsor
10 Previous Clinical Trials
594 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Study Drug Treated, BMX-010 0.5%
- Group 2: Study Drug Treated, BMX-010 0.1%
- Group 3: Placebo Treated
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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