Publications by authors named "David Berk"

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Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials.
Kim A Papp, James Q Del Rosso, Mark G Lebwohl, Melinda J Gooderham, Adelaide A Hebert, David R Berk

Dermatol Ther (Heidelb)· December 2025

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Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks.
Andrew F Alexis, Michael Bukhalo, Fran E Cook-Bolden, James Q Del Rosso, Zoe D Draelos, David R Berk

Am J Clin Dermatol· November 2025

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Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years.
Adelaide A Hebert, Shireen V Guide, Vlada Groysman, Mercedes E Gonzalez, Daisy Blanco, David R Berk

Pediatr Dermatol· August 2025

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Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial.
Melinda J Gooderham, Javier Alonso-Llamazares, Jerry Bagel, Neal Bhatia, Michael Bukhalo, David R Berk

JAMA Dermatol· July 2025

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Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial.
Lawrence F Eichenfield, Rocco Serrao, Vimal H Prajapati, John C Browning, Lisa Swanson, David R Berk

Pediatr Dermatol· March 2025

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Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial.
Eric L Simpson, Lawrence F Eichenfield, Kim A Papp, Seth B Forman, Adelaide A Hebert, David R Berk

Dermatitis· January 2025

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Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials.
Eric L Simpson, Lawrence F Eichenfield, Javier Alonso-Llamazares, Zoe D Draelos, Laura K Ferris, David R Berk

JAMA Dermatol· November 2024

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Assessment of the Vehicle for Roflumilast Cream Compared to a Ceramide-Containing Moisturizing Cream in Mild Eczema.
Zoe Diana Draelos, Robert C Higham, David W Osborne, Melissa S Seal, Patrick Burnett, David R Berk

J Drugs Dermatol· October 2024

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Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial.
Linda Stein Gold, David N Adam, Lorne Albrecht, Javier Alonso-Llamazares, Laura K Ferris, David R Berk

J Am Acad Dermatol· August 2024

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Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial.
Andrew Blauvelt, Zoe D Draelos, Linda Stein Gold, Javier Alonso-Llamazares, Neal Bhatia, David R Berk

J Am Acad Dermatol· May 2024

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Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study.
Leon H Kircik, Javier Alonso-Llamazares, Neal Bhatia, Michael Bukhalo, Alim R Devani, David R Berk

Br J Dermatol· September 2023

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Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial.
Matthew J Zirwas, Zoe D Draelos, Janet DuBois, Leon H Kircik, Angela Y Moore, David R Berk

JAMA Dermatol· June 2023

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Efficacy and safety of roflumilast cream for chronic plaque psoriasis with facial/neck and intertriginous area involvement: a post hoc analysis from a randomized controlled trial.
Zoe D Draelos, David N Adam, H Chih-Ho Hong, Mark G Lebwohl, Charles W Lynde, David R Berk

Br J Dermatol· May 2023

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Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial.
Linda Stein Gold, Javier Alonso-Llamazares, Zoe D Draelos, Melinda J Gooderham, Steven E Kempers, David R Berk

Am J Clin Dermatol· March 2023

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Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies.
Archie W Thurston, David W Osborne, Scott Snyder, Robert C Higham, Patrick Burnett, David R Berk

Am J Clin Dermatol· March 2023

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The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Patients With Atopic Dermatitis: Randomized, Double-Blind, Phase 2 Proof of Concept Study.
Melinda Gooderham, Leon Kircik, Matthew Zirwas, Mark Lee, Steven Kempers, David Berk

J Drugs Dermatol· February 2023

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Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.
Mark G Lebwohl, Leon H Kircik, Angela Y Moore, Linda Stein Gold, Zoe D Draelos, David R Berk

JAMA· September 2022

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Biallelic variants in RNU12 cause CDAGS syndrome.
Chao Xing, Mohammed Kanchwala, Jonathan J Rios, Tommy Hyatt, Richard C Wang, David Berk

Hum Mutat· August 2021

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The Proposed PASI-HD Provides More Precise Assessment of Plaque Psoriasis Severity in Anatomical Regions with a Low Area Score.
Kim A Papp, Mark G Lebwohl, Leon H Kircik, David M Pariser, Bruce Strober, David R Berk

Dermatol Ther (Heidelb)· August 2021

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Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study.
Kim A Papp, Melinda Gooderham, Michael Droege, Charlotte Merritt, David W Osborne, David R Berk

J Drugs Dermatol· August 2020

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Trial of Roflumilast Cream for Chronic Plaque Psoriasis.
Mark G Lebwohl, Kim A Papp, Linda Stein Gold, Melinda J Gooderham, Leon H Kircik, David R Berk

N Engl J Med· July 2020

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Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study.
David M Pariser, Lawrence J Green, Edward L Lain, Carsten Schmitz, Amy S Chinigo, David R Berk

J Clin Aesthet Dermatol· November 2019

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Topical Oxymetazoline Cream 1.0% for Persistent Facial Erythema Associated With Rosacea: Pooled Analysis of the Two Phase 3, 29-Day, Randomized, Controlled REVEAL Trials.
Linda Stein-Gold, Leon Kircik, Zoe Diana Draelos, Philip Werschler, Janet DuBois, David Berk

J Drugs Dermatol· November 2018

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Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials.
Angela Moore, Lawrence J Green, Suzanne Bruce, Neil Sadick, Eduardo Tschen, David R Berk

J Drugs Dermatol· September 2018

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Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.
Emil A Tanghetti, Jeffrey S Dover, David J Goldberg, Sunil S Dhawan, Lei Luo, David R Berk

J Drugs Dermatol· June 2018

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