Topical roflumilast in adults with atopic dermatitis

Exclusion Criteria

• 1. Has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening visit.
• 2. Has a history of AD unresponsive or poorly responsive to topical treatments.
• 3. Has a history of hypersensitivity to phosphodiesterase (PDE)-4 inhibitors or to drugs of similar chemical classes or any inactive ingredients of the trial medication.
• 4. Has clinically significant abnormal hematological parameters of hemoglobin, hematocrit or erythrocytes at Screening, in the judgment of the investigator.
• 5. Has a history or current clinically relevant allergy or idiosyncrasy to drugs or food.
• 6. Had extensive exposure to ultraviolet (UV) light in the 4 weeks prior to first application of study medication, including tanning and sun beds or is intending to have such exposure during the study treatment that may interfere with the study assessments as judged by the investigator.
• 7. Has evidence of oozing of target lesion.
• 8. Has a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated.
• 9. Had systemic treatment with corticosteroids or retinoids for studied condition within 3 months prior to the first application of study medication.
• 10. Had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 4 weeks prior to first application of study medication.
• 11. Had treatment with systemic/locally acting medications/procedures that might counter or influence the study aim within 4 weeks prior to first application of study medication and during the study (e.g., anti-histamines).
• 12. Has used emollients/moisturizers on areas to be treated within 24 hours prior to the first application of study medication.
• 13. Has used biologics at any time for treatment of AD.
• 14. Is currently enrolled in an investigational drug or device study.
• 15. Has any clinically significant illness that may influence the outcome of the trial from 4 weeks before Day 1 through trial completion.
• 16. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 × upper limit of normal (ULN), or other clinically significant abnormal laboratory test that, in the opinion of the Investigator, would compromise the participant's ability to safely complete the trial.
• 17. Has a significant medical condition and/or conditions that, in the opinion of the Investigator, would interfere with the treatment, safety or compliance with the protocol.
• 18. Has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• 19. Has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming >14 alcoholic drinks per week.
• 20. If female, is pregnant, nursing or planning a pregnancy during the study period.
• 21. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study medication. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin.
• 22. Has a chronic or clinically relevant acute infection.
• 23. Has a history of depression associated with suicidal ideation and behavior.
• 24. Has hemodynamically significant cardiac arrhythmias or heart valve deformations.
• 25. Is an immediate family member, a study site employee, in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or at risk for consenting under duress.
• 26. Was institutionalized because of a legal or regulatory order.