Study in Subjects With Moderate Atopic Dermatitis

Exclusion Criteria

• •1. Subject has spontaneously improving or rapidly deteriorating AD
• •2. Subject has clinically infected AD
• •3. Subject has any signs or symptoms associated with topical AD therapy which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
• •4. Subject has any clinically significant laboratory abnormality, medical condition or physical/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results
• •5. Subjects with a past history of cancer or lymphoproliferative disease within 5 years prior to Visit 2 (baseline) (subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded)
• •6. Subject is known to have immune deficiency or is immunocompromised
• •7. Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus)
• •8. Subject had major surgery within 8 weeks prior to Visit 2 (baseline) or has a major surgery planned during the study.
• •9. Topical medications, including but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices and bleach bath within 2 weeks prior to Visit 2 (baseline)
• •10. Subject has used any non-medicated topical product (e.g., lotions, gels, creams, ointments) in the planned treatment area 4 hours prior to Visit 2 (baseline)
• •11. Subject has used the following systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Visit 2 (baseline) (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide \[hydroxyurea\], azathioprine, oral/injectable corticosteroids) within 4 weeks prior to Screening. Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
• •12. Subject has used any systemic antibiotics within 2 weeks prior to Visit 2 (baseline)
• •13. Subject has used hydroxyzine or diphenhydramine within 1 week prior to Visit 2 (baseline), unless on a stable dose.
• •14. Subject has used topical doxepin within 1 week prior to Visit 2 (baseline).
• •15. Subject has used topical products containing urea within 1 week prior to Visit 2 (baseline)
• •16. Subject has used or is planning to use any phototherapy (e.g., UVA/UVB therapy, or PUVA therapy), excessive natural or artificial ultraviolent radiation (e.g., sunlight, tanning beds) which, in the investigator's opinion, might affect AD within 4 weeks prior to Visit 2 (baseline)
• •17. Biologic therapies (e.g., Dupilumab) within 12 weeks or 5 half-lives prior to Visit 2 (baseline)
• •18. Subject has a history of sensitivity to any of the ingredients in the study medications
• •19. Subject has any known concomitant dermatologic or medical condition which, in the investigator's opinion, might impair evaluation of the areas of AD being treated or which exposes the subject to an unacceptable risk by study participation (e.g., psoriasis, rosacea, lichen planus, lichen simplex chronicus,…)
• •20. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• •21. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Visit 2 (baseline)
• •22. Subject has participated in a nonbiological investigational drug trial in which administration of an investigational study medication occurred within 4 weeks prior to Visit 2 (baseline)