|
|||||
|
|
Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry |
|
| Authors: | Elaine C. Siegfried MD Jennifer C. Jaworski MS Lawrence F. Eichenfield MD Amy Paller MD MS Adelaide A. Hebert MD Eric L. Simpson MD MCR Emily Altman MD Charles Arena MD Andrew Blauvelt MD MBA Julie Block BA Mark Boguniewicz MD Suephy Chen MD MS Kelly Cordoro MD Diane Hanna DNP Kimberly Horii MD Thomas Hultsch MD PhD James Lee MD PhD Donald Y. Leung MD PhD Peter Lio MD Joshua Milner MD Theodore Omachi MD Christine Schneider PhD LSC Lynda Schneider MD Robert Sidbury MD MPH Timothy Smith MPP Jeffrey Sugarman MD PhD Sharif Taha PhD Susan Tofte RN MS FNP‐C Megha Tollefson MD Wynnis L. Tom MD Dennis P. West PhD FCCP CIP Lucinda Whitney DNP APRN PMHNP‐BC Lee Zane MD MAS |
| Affiliation: | 1. Department of Pediatrics, Saint Louis University and Cardinal Glennon Children's Hospital, St. Louis, MO, USA;2. Prescott Medical Communications Group, Chicago, IL, USA;3. Department of Dermatology, School of Medicine, University of California, and Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital‐San Diego, San Diego, CA, USA;4. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA;5. Division of Dermatology, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA;6. Department of Dermatology, UTHealth McGovern Medical School at Houston, Houston, TX, USA;7. Department of Dermatology, Oregon Health & Science University, Portland, OR, USA;8. Summit Medical Group, Berkeley Heights, NJ, USA;9. Clinical Development & Medical Affairs, Regeneron Pharmaceuticals, Tarrytown, NY, USA;10. Oregon Medical Research Center, Portland, OR, USA;11. National Eczema Association, San Rafael, CA, USA;12. Department of Pediatrics, National Jewish Health and Division of Pediatric Allergy‐Immunology, University of Colorado School of Medicine, Denver, CO, USA;13. Department of Dermatology, Emory University, and Division of Dermatology, Atlanta Veterans Affairs Medical Center, Atlanta, GA, USA;14. Department of Dermatology, University of California, San Francisco, CA, USA;15. Medical Affairs, Regeneron Pharmaceuticals, Tarrytown, NY, USA;16. Division of Dermatology, Children's Mercy and University of Missouri, Kansas City, MO, USA;17. Translational Medicine, Sanofi‐Genzyme, Cambridge, MA, USA;18. Dermavant Sciences, Raleigh‐Durham, NC, USA;19. Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA;20. Immunology/Respiratory, Genentech, Inc., San Francisco, CA, USA;21. Kreider Services, Dixon, IL, USA;22. Department of Pediatrics, Harvard Medical School and Division of Allergy and Immunology, Boston Children's Hospital, Boston, MA, USA;23. Division of Dermatology, Seattle Children's Hospital and Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA;24. Department of Dermatology, Mayo Clinic, Rochester, MN, USA;25. School of Nursing, University of Kansas Medical Center, Kansas City, KS, USA;26. Anacor Pharmaceuticals, Palo Alto, CA, USA |
| Abstract: | Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high‐level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for “the Agency's current thinking on a particular subject.” Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). |
| Keywords: | atopic dermatitis clinical trials drug development eczema FDA IGA therapy‐systemic therapy‐topical |