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Topical AMTX-100 CF for Eczema
Phase 1 & 2
Waitlist Available
Research Sponsored by Amytrx Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 28
Awards & highlights
Study Summary
This trial is to study a new drug, AMTX-100 CF, for atopic dermatitis. The first phase will test how well the drug works on 25 people with mild to moderate atopic dermatitis. The second phase will test different concentrations of the drug on 120 people with mild to moderate atopic dermatitis to see how well it works.
Who is the study for?
Adults over 18 with mild to moderate Atopic Dermatitis, covering 3-12% of their body. They must be in good health and have been using a basic emollient for at least one week before the trial. Women must not be pregnant or breastfeeding and agree to use contraception if fertile.Check my eligibility
What is being tested?
The trial is testing AMTX-100 CF cream (1.1%) against a placebo in two phases: first, determining the maximum dose that's tolerable; second, assessing its effectiveness on different skin areas affected by eczema.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to topical medications such as skin irritation, redness, itching or burning sensation at the application site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 (Phase I) Primary: Maximum Tolerable Dose
Cephalopelvic Proportion
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Group A: 1.1% w/wExperimental Treatment1 Intervention
AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
Group II: Part 1 Dose Escalation: 3% to 70% of the BSAExperimental Treatment1 Intervention
Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
Group III: Part 2 Group B: PlaceboPlacebo Group1 Intervention
Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
1.1% w/w AMTX-100 CF-part1
2020
Completed Phase 2
~100
1.1% w/w AMTX-100 CF3-part2
2020
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,591 Total Patients Enrolled
Amytrx Therapeutics, Inc.Lead Sponsor
Arezou Bayat, MD, MPHStudy DirectorAmarex Clinical Research, LLC (Amarex)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- For the first group, the affected skin area must be between 3% and 6% of the total body surface area.In cohort 2, the affected skin area is between 6% and 12% of the total body surface area.You have unusual vital signs, physical exam results, or lab test findings that are concerning to the doctor.You have been using a basic, additive-free moisturizer twice a day for at least one week before the start of the study.You have used certain skin medications within 14 days of the start of the study.Your skin condition is rated as moderate or severe by the doctor during the screening and baseline visits.You have a current skin rash or a history of severe allergic reactions.You have not received any systemic treatments, immunotherapy, biologics, or phototherapy for atopic dermatitis in the last 12 months before joining the study.Women who could get pregnant need to have a negative pregnancy test before joining the study.You have severe kidney, liver, or heart problems.You have a skin condition that could affect the assessment of the treatment areas.Women who have given birth within the last 3 months before screening.You have already been treated with AMTX-100 CF.You have severe eczema and need strong corticosteroid creams regularly to manage it.You have a serious infection in your body.You have used a tanning booth or bed within the last 4 weeks before the screening visit.You have a very severe type of atopic dermatitis, as determined by a vIGA-AD™ score higher than 3.Your skin condition is mild to moderate according to the doctor's assessment.You have mild to moderate Atopic Dermatitis (AD) confirmed by a doctor for at least 6 months before joining the study.Your body surface area is between 1.5 and 2.1 square meters.You have been diagnosed with mild to moderate Atopic Dermatitis (AD) by a doctor for at least 6 months before joining the study.You have atopic dermatitis that affects a certain percentage of your body and can be treated with topical medication.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 Group A: 1.1% w/w
- Group 2: Part 2 Group B: Placebo
- Group 3: Part 1 Dose Escalation: 3% to 70% of the BSA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study looking for new participants?
"The clinicaltrials.gov website indicates that this study has completed patient recruitment as of September 27th, 2020. This particular trial was originally posted on March 10th, 2020. Although this specific trial is not enrolling patients, there are still 256 other open trials seeking participants."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Amytrx Investigational site
What portion of applicants met pre-screening criteria?
Met criteria
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