Atopic Dermatitis Clinical Trials

⁃ Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:

• Participant and/or parent/legal guardian must be able to understand and provide informed consent and assent (if applicable).

• Male or female participant 6 years of age or older.

• Meet ADRN Standard Diagnostic Criteria for active AD.

• Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:

• Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.

• Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.

• Have an IGA score of two or greater.

• Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.

‣ Willing to remain abstinent from intercourse that may result in a pregnancy.

⁃ Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:

• Permanent sterilization of partner

∙ Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.

∙ Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline

∙ Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)

• Have obtained negative pregnancy test results during both the Screening and Baseline Visits.