TY - JOUR
T1 - The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Patients With Atopic Dermatitis
T2 - Randomized, Double-Blind, Phase 2 Proof of Concept Study
AU - Gooderham, Melinda
AU - Kircik, Leon
AU - Zirwas, Matthew
AU - Lee, Mark
AU - Kempers, Steven
AU - Draelos, Zoe
AU - Ferris, Laura
AU - Jones, Terry
AU - Saint-Cyr Proulx, Etienne
AU - Bissonnette, Robert
AU - Bhatia, Neal
AU - Koppel, Robert
AU - Guenthner, Scott
AU - Eads, Kimmie
AU - Welgus, Howard
AU - Merritt, Charlotte
AU - Elias, Meg
AU - Navale, Lynn
AU - Higham, Robert
AU - Droege, Michael
AU - Berk, David
PY - 2023/2/1
Y1 - 2023/2/1
N2 - BACKGROUND: Patients with atopic dermatitis (AD) need safe and effective topical treatments. OBJECTIVE: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD. METHODS: In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast cream 0.05%, or vehicle cream for 4 weeks. Absolute change from baseline in Eczema Area and Severity Index (EASI) score at week 4 (primary endpoint), percentage change and responder rates, Validated Investigator Global Assessment-AD (vIGA-AD), and safety were assessed. RESULTS: At week 4, mean absolute changes in EASI were −6.4 (P=0.097 vs vehicle), −6.0 (P=0.356), and −4.8 with roflumilast 0.15%, roflumilast 0.05%, and vehicle, respectively. Significant improvements were observed for percentage change from baseline in EASI, patients reaching 75% improvement in EASI, and patients achieving vIGA-AD score of “clear” or “almost clear.” Treatment-related adverse events (AEs) occurred in 2 (2.2%) patients receiving roflumilast (mild rash and moderate application site pain). Only 1 (1.1%) patient receiving roflumilast discontinued study/drug due to an AE. LIMITATIONS: Small number of patients. CONCLUSIONS: Results support additional larger clinical trials of roflumilast cream to assess its potential as a once-daily, nonsteroidal topical AD treatment. CLINICALTRIALS: gov identifier NCT03916081 J Drugs Dermatol. 2023;22(2):139-147. doi:10.36849/JDD.7295.
AB - BACKGROUND: Patients with atopic dermatitis (AD) need safe and effective topical treatments. OBJECTIVE: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD. METHODS: In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast cream 0.05%, or vehicle cream for 4 weeks. Absolute change from baseline in Eczema Area and Severity Index (EASI) score at week 4 (primary endpoint), percentage change and responder rates, Validated Investigator Global Assessment-AD (vIGA-AD), and safety were assessed. RESULTS: At week 4, mean absolute changes in EASI were −6.4 (P=0.097 vs vehicle), −6.0 (P=0.356), and −4.8 with roflumilast 0.15%, roflumilast 0.05%, and vehicle, respectively. Significant improvements were observed for percentage change from baseline in EASI, patients reaching 75% improvement in EASI, and patients achieving vIGA-AD score of “clear” or “almost clear.” Treatment-related adverse events (AEs) occurred in 2 (2.2%) patients receiving roflumilast (mild rash and moderate application site pain). Only 1 (1.1%) patient receiving roflumilast discontinued study/drug due to an AE. LIMITATIONS: Small number of patients. CONCLUSIONS: Results support additional larger clinical trials of roflumilast cream to assess its potential as a once-daily, nonsteroidal topical AD treatment. CLINICALTRIALS: gov identifier NCT03916081 J Drugs Dermatol. 2023;22(2):139-147. doi:10.36849/JDD.7295.
UR - http://www.scopus.com/inward/record.url?scp=85147536536&partnerID=8YFLogxK
U2 - 10.36849/JDD.7295
DO - 10.36849/JDD.7295
M3 - Article
C2 - 36745371
AN - SCOPUS:85147536536
SN - 1545-9616
VL - 22
SP - 139
EP - 147
JO - Journal of Drugs in Dermatology
JF - Journal of Drugs in Dermatology
IS - 2
ER -