Journal of the American Academy of Dermatology
Tacrolimus Ointment: Advancing the Treatment of Atopic DermatitisA 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients☆,☆☆,★,★★,♢,♢♢
Section snippets
Study design
This randomized, double-blind, parallel group, 3-arm, vehicle-controlled study was conducted at 23 centers in the United States between August 1997 and June 1998. Pediatric patients applied either vehicle control (ointment base), 0.03% tacrolimus ointment, or 0.1% tacrolimus ointment. Patients who met entry criteria were randomized with a 1:1:1 allocation ratio and were stratified before randomization by age (≤ 6 years or ≥ 7 years) within each center. The investigator, patient,
Patient disposition and characteristics
A total of 351 patients were enrolled and received at least one dose of randomized study medication; 116 patients received vehicle, 117 received 0.03% tacrolimus ointment, and 118 received 0.1% tacrolimus ointment. A total of 105 patients did not complete the study, the majority (n = 65) of whom were in the vehicle treatment group. Of these vehicle-treated patients, 71% discontinued because of lack of efficacy. The most common reason for discontinuation in either tacrolimus ointment treatment
Discussion
Both concentrations of tacrolimus ointment (0.03% and 0.1%) were demonstrated to be safe and effective for the treatment of moderate to severe atopic dermatitis in children 2 to 15 years of age. Both concentrations of tacrolimus ointment produced substantial clinical improvement and rapidly (generally during the first week of treatment) decreased the amount of affected body surface area while relieving such signs and symptoms as pruritus, edema, erythema, excoriation, lichenification, oozing,
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2021, Anais Brasileiros de DermatologiaCitation Excerpt :Therefore, it inhibits the transcription of some inflammatory cytokines, such as IL-2, IL-3, IL-4, TNF-alpha, and the activation of T lymphocytes, reduces the population of dendritic cells, which are antigen-presenting and can trigger an allergic inflammatory response, reduces mast cell and basophil mediators (histamine), reduces pruritus by decreasing the production of substance P and neuronal growth factor.5,6 It shows less skin absorption compared to glucocorticoids, which increases its safety of use, due to the lower potential for systemic adverse effects.7,8 This is a study about its topical use, on unaesthetic scars, to investigate whether it would promote apoptosis and suppression of fibroblast activity.6
Phosphodiesterase 4 inhibitors
2018, Journal of the American Academy of Dermatology
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Supported by an educational grant from Fujisawa Healthcare, Inc, Deerfield, Illinois
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This article is part of a supplement sponsored by Fujisawa Healthcare, Inc.
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Dr Paller has received grant support, been a consultant, and has been on the speaker's bureau of Fujisawa Healthcare, Inc. Dr Eichenfeld has received grant/research support and been a consultant for Fujisawa. Dr Leung has received grant/research support from Tanox, Fujisawa Healthcare, and Novartis and has been on the speakers' bureaus of Glaxo and Schering. Dr Stewart has received grant/research support from Fujisawa. Dr Appell has received support via Hill Top Research, Inc.
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Reprint requests: Amy Paller, MD, Division of Dermatology #107, Children's Memorial Hospital, 2300 Children's Plaza, Chicago, IL 60614. E-mail: [email protected].
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Additional members of the Tacrolimus Ointment Study Group: Maggie Ayers, Fujisawa Healthcare, Inc, Deerfield, Ill; Mark Boguniewicz, MD, National Jewish Medical and Research Center, Denver, Colo; Debra Breneman, MD, University Dermatology Consultants, Inc, Cincinnati, Ohio; Kevin D. Cooper, MD, University Hospital of Cleveland, Cleveland, Ohio; Loretta Davis, MD, Medical College of Georgia, Augusta, Ga; Lynn Drake, MD, Oklahoma University Health Sciences Center, Oklahoma City, Okla; Jay Erdman, Fujisawa Healthcare, Inc, Deerfield, Ill; Alan Fleischer, MD, Wake Forest University School of Medicine, Winston-Salem, NC; Jon M. Hanifin, MD, Oregon Health Sciences University, Portland, Ore; Ellen Hodosh, PhD, Fujisawa Healthcare, Inc, Deerfield, Ill; Eileen Jaracz, PharmD, Fujisawa Healthcare, Inc, Deerfield, Ill; Teri Kahn, MD, Cleveland Clinic Foundation, Cleveland, Ohio; Sewon Kang, MD, University of Michigan Medical Center, Ann Arbor, Mich; Gerald T. Kilpatrick, MD, Hill Top Research, Inc, West Palm Beach, Fla; Ira D. Lawrence, MD, Fujisawa Healthcare, Inc, Deerfield, Ill; Mark R. Ling, MD, PhD, Emory University (currently at MedaPhase), Atlanta, Ga; Jan M. Logan, Fujisawa Healthcare, Inc, Deerfield, Ill; Anne W. Lucky, MD, Dermatology Research Associates, Cincinnati, Ohio; Rochelle M. Maher, Fujisawa Healthcare, Inc, Deerfield, Ill; Calvin O. McCall, MD, Emory University, Atlanta, Ga; Mamoru Miyake, Fujisawa Healthcare, Inc, Deerfield, Ill; Eugene Monroe, MD, Advanced HealthCare, SC, Milwaukee, Wis; David Pariser, MD, Eastern Virginia Medical School, Norfolk, Va; Linda Pedersen, Fujisawa Healthcare, Inc, Deerfield, Ill; Scott Phillips, MD, University of Chicago, Chicago, Ill; Elyse Rafal, MD, University Medical Center at Stony Brook, Stony Brook, NY; Yoichi Satoi, Fujisawa Healthcare, Inc, Deerfield, Ill; Ronald Savin, MD, Savin Dermatology Center, New Haven, Conn; Lynda C. Schneider, MD, Children's Hospital—Harvard Medical School, Boston, Mass; Daniel Shrager, MD, Fujisawa Healthcare, Inc, Deerfield, Ill; Elaine Siegfried, MD, Saint Louis University Health Sciences Center, St Louis, Mo; Atsushi Tanase, PharmD, Fujisawa Pharmaceutical Ltd, Osaka, Japan; Suzanne Zheng, Fujisawa Healthcare, Inc, Deerfield, Ill.
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J Am Acad Dermatol 2001;44:S47-57.