Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis

Part 1 Inclusion Criteria:

Subjects are required to meet ALL of the following criteria for enrollment into the Phase I (Part 1) of the study:

• Male or female subjects who are 18 years or older
• If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
• All fertile female subjects as described above need to have a negative urine pregnancy test at the screening and baseline visits
• Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements
• Subject is able to apply topical products on all treatable assigned areas by self and/or caregiver (if applicable), per the Investigator
• Subject is in general good physical/mental health per the Investigator
• Subject's Total Body Surface Area (BSA) is between 1.5 and 2.1 m2 per the Mosteller formula
• The subject has physician confirmed mild to moderate Atopic Dermatitis (AD) defined by the Eichenfield revised criteria of Hannifin and Rajka, for at least 6 months prior to study enrollment
• Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 2 or 3 (mild to moderate) at the screening and baseline visits
• Subject has Atopic Dermatitis (AD) involvement with eligible treatable percent of the BSA appropriate for topical treatment per the assigned cohort at the screening and baseline visits per below:
• Cohort 1: 3% BSA ≤ AD Affected Area ≤ 6% BSA
• Cohort 2: 6% BSA < AD Affected Area ≤ 12% BSA
• Cohort 3: 12% BSA < AD Affected Area ≤ 24% BSA
• Cohort 4: 24% BSA < AD Affected Area ≤ 48% BSA
• Cohort 5: 48% BSA < AD Affected Area ≤ 70% BSA

Note: Calculation of Treatable BSA percentage (% of the total BSA that is AD-involved, excluding the scalp, face, eyes, eyelids, neck, hands, palms, feet, groin, genitals or axillae) will be completed by the method below:

o "Handprint Method": the area represented by the palm with all five digits adducted together is approximately 1% of the subject's BSA

Part 1 Exclusion Criteria:

Subjects are required to meet NONE of the following criteria for enrollment into the Phase I (Part 1) of the study:

• Pregnant or lactating females or women who are planning for pregnancy in the next 6 months
• Women at postpartum for 3 months or less prior to screening
• Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator may interfere with the conduct of the study
• Subjects with abnormal vital signs, physical and dermatological exams or clinical laboratory evaluations considered clinically significant by the Principal Investigator, which in the opinion of the PI would significantly interfere with the study conduct
• Subjects with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator
• The subject has a planned major surgical intervention for a pre-existing condition within the duration of the study
• The subject has a history of drug or alcohol abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.
• Participation in a clinical trial within 3 months, or more than two clinical trials within 12 months prior to screening
• Concurrent or