Abstract:
BACKGROUND:Safe and efficacious topical treatments are needed for atopic dermatitis (AD). OBJECTIVE:We assessed the safety and efficacy of tapinarof cream (2 concentrations and 2 application frequencies) in patients with AD. METHODS:A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline. Primary end points included an Investigator's Global Assessment score of clear or almost clear (0 or 1) and a minimum 2-grade improvement (treatment success) at week 12. Secondary analyses included a 75% or greater improvement in Eczema Area and Severity Index score, reduction of numeric rating scale (NRS) score for itch from baseline, and other prespecified end points. RESULTS:The rates of treatment success with tapinarof cream at week 12 were 53% (a concentration of 1% twice daily), 46% (a concentration of 1% once daily), 37% (a concentration of 0.5% twice daily), 34% (0.5% once daily), 24% (vehicle twice daily), and 28% (vehicle once daily). The rate with a concentration of 1% twice daily (53%) was statistically significantly higher than the rate with vehicle twice daily (24%). Treatment success was maintained for 4 weeks after the end of tapinarof treatment. The rate of treatment-emergent adverse events was higher with tapinarof (93 of 165 [56%]) than with vehicle (34 of 82 [41%]), and the events were mild to moderate in intensity. LIMITATIONS:Large confirmation trials are needed. CONCLUSIONS:Tapinarof cream is efficacious and well tolerated in adolescent and adult patients with AD.
journal_name
J Am Acad Dermatoljournal_title
Journal of the American Academy of Dermatologyauthors
Peppers J,Paller AS,Maeda-Chubachi T,Wu S,Robbins K,Gallagher K,Kraus JEdoi
10.1016/j.jaad.2018.06.047subject
Has Abstractpub_date
2019-01-01 00:00:00pages
89-98.e3issue
1eissn
0190-9622issn
1097-6787pii
S0190-9622(18)32203-5journal_volume
80pub_type
杂志文章,随机对照试验abstract::A patient with acquired immunodeficiency syndrome presented with multiple pruritic papules and nodules over the trunk and extremities. Biopsy specimens from two of these lesions contained granules within abscesses of the papillary dermis. There were numerous gram-positive cocci within the granules. Culture of one lesi...
journal_title:Journal of the American Academy of Dermatology
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doi:10.1016/s0190-9622(87)80072-5
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abstract::Palpable purpura in a follicular localization developed in association with acute epididymitis in a white man who was seropositive for the human immunodeficiency virus (HIV). Biopsy specimens revealed a leukocytoclastic vasculitis with follicular accentuation. With antibiotic therapy the vasculitis resolved, but it re...
journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
pub_type: 杂志文章,评审
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