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Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis Lawrence F. Eichenfield, MD, Robert S. Call, MD, Douglass W. Forsha, MD, Joseph Fowler, MD, Adelaide A. Hebert, MD, Mary Spellman, MD, Linda F. Stein Gold, MD, Merrie Van Syoc, BS, Lee T. Zane, MD, Eduardo Tschen, MD, MBA Journal of the American Academy of Dermatology Volume 77, Issue 4, Pages e5 (October 2017) DOI: /j.jaad Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 1 Study design, including the phase 3 pivotal trials (AD-301, AD-302) and the extension study (AD-303). Pivotal trials AD-301 and AD-302 were identically designed, 4-week, double-blind, vehicle-controlled, safety and efficacy studies. AD-303 was a long-term (48-week), open-label, single-arm safety study. ∗Proprietary vehicle developed by Anacor Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. BID, Twice a day; ISGA, Investigator's Static Global Assessment. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions
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Fig 2 Treatment-related AEs reported by ≥1% of patients in the pivotal and long-term safety study by age group. Treatment-related AEs included general disorders and administration site conditions (A); infections, infestations, and investigations (B); and skin and subcutaneous tissue disorders (C). aApplication-site pain included burning or stinging. bInvestigations included clinical laboratory tests, radiologic tests, physical examination parameters, and physiological tests. cDermatitis atopic refers to worsening, exacerbation, flare, or flare-up of an existing condition. MedDRA, Medical Dictionary for Regulatory Activities; TEAEs, treatment-emergent adverse events. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions
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Supplemental Fig 1 Treatment-related AEs reported by ≥1% of patients with atopic dermatitis during the long-term safety study (AD-303) by 12-week time period. Treatment-related TEAEs included general disorders and administration site conditions (A) and skin and subcutaneous tissue disorders (B). aApplication-site pain included burning and/or stinging. bAll dermatitis atopic events refer to worsening, exacerbation, flare, or flare-up of an existing condition. MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event. Journal of the American Academy of Dermatology , e5DOI: ( /j.jaad ) Copyright © 2017 American Academy of Dermatology, Inc. Terms and Conditions
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