PMID- 36745371
OWN - NLM
STAT- MEDLINE
DCOM- 20230211
LR  - 20230211
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 22
IP  - 2
DP  - 2023 Feb 1
TI  - 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.
PG  - 139-147
LID - 10.36849/JDD.7295 [doi]
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.
FAU - Gooderham, Melinda
AU  - Gooderham M
FAU - Kircik, Leon
AU  - Kircik L
FAU - Zirwas, Matthew
AU  - Zirwas M
FAU - Lee, Mark
AU  - Lee M
FAU - Kempers, Steven
AU  - Kempers S
FAU - Draelos, Zoe
AU  - Draelos Z
FAU - Ferris, Laura
AU  - Ferris L
FAU - Jones, Terry
AU  - Jones T
FAU - Saint-Cyr Proulx, Etienne
AU  - Saint-Cyr Proulx E
FAU - Bissonnette, Robert
AU  - Bissonnette R
FAU - Bhatia, Neal
AU  - Bhatia N
FAU - Koppel, Robert
AU  - Koppel R
FAU - Guenthner, Scott
AU  - Guenthner S
FAU - Eads, Kimmie
AU  - Eads K
FAU - Welgus, Howard
AU  - Welgus H
FAU - Merritt, Charlotte
AU  - Merritt C
FAU - Elias, Meg
AU  - Elias M
FAU - Navale, Lynn
AU  - Navale L
FAU - Higham, Robert
AU  - Higham R
FAU - Droege, Michael
AU  - Droege M
FAU - Berk, David
AU  - Berk D
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Aminopyridines)
RN  - 0 (Benzamides)
RN  - 0 (Emollients)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
MH  - Humans
MH  - Aminopyridines/adverse effects
MH  - Benzamides/adverse effects
MH  - *Dermatitis, Atopic/diagnosis/drug therapy
MH  - Double-Blind Method
MH  - Emollients/therapeutic use
MH  - Proof of Concept Study
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2023/02/07 06:00
MHDA- 2023/02/09 06:00
CRDT- 2023/02/06 11:23
PHST- 2023/02/06 11:23 [entrez]
PHST- 2023/02/07 06:00 [pubmed]
PHST- 2023/02/09 06:00 [medline]
AID - S1545961623P0139X [pii]
AID - 10.36849/JDD.7295 [doi]
PST - ppublish
SO  - J Drugs Dermatol. 2023 Feb 1;22(2):139-147. doi: 10.36849/JDD.7295.