PMID- 28528605
OWN - NLM
STAT- MEDLINE
DCOM- 20190711
LR  - 20190711
IS  - 1540-9740 (Print)
IS  - 1540-9740 (Linking)
VI  - 15
IP  - 2
DP  - 2017
TI  - Fixed-Combination Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam Is 
      Well Tolerated in Patients with Psoriasis Vulgaris: Pooled Data from Three 
      Randomized Controlled Studies.
PG  - 119-124
AB  - The authors performed a pooled analysis of three randomized, 4-week, phase II/III 
      studies in adult patients with mild to severe psoriasis and assessed the 
      safety/tolerability of aerosol foam fixed-combination calcipotriene 0.005% (Cal) 
      plus betamethasone dipropionate 0.064% (BD) versus different comparators. 
      Overall, 1104 patients were randomized to Cal/BD aerosol foam (n=564), Cal 
      aerosol foam (n=101), BD aerosol foam (n=101), aerosol foam vehicle (n=152), 
      Cal/BD ointment (n=135), or ointment vehicle (n=51). A total of 543 Cal/BD 
      patients in the aerosol foam group (96.3%) completed the studies, with only two 
      patients (0.4%) withdrawing as a result of adverse events (AEs). Ninety-five AEs 
      were reported in 78 patients (13.8%) receiving Cal/BD aerosol foam; similar event 
      rates were observed in other groups. The most common AEs with Cal/BD aerosol foam 
      were nasopharyngitis (n=6, 1.1%) and application-site pain (n=4, 0.7%); most AEs 
      were mild (n=71/95; 74.7%). Adverse drug reactions (ADRs) experienced by two or 
      more patients receiving Cal/BD aerosol foam were application-site pain (n=4; 
      0.7%) and application-site pruritus (n=2; 0.4%). There were no clinically 
      relevant changes in calcium homeostasis. Cal/BD aerosol foam has a positive 
      benefit-risk profile for the treatment of psoriasis vulgaris; the superior 
      efficacy versus Cal/BD ointment and the individual active ingredients is not 
      associated with poorer tolerability.
FAU - Menter, Alan
AU  - Menter A
AD  - Division of Dermatology, Baylor University Medical Center, Dallas, TX; 
      amderm@gmail.com.
FAU - Gold, Linda Stein
AU  - Gold LS
AD  - Dermatology Clinical Research, Henry Ford Health System, Detroit, MI.
FAU - Koo, John
AU  - Koo J
AD  - Department of Dermatology, University of California, San Francisco, CA.
FAU - Villumsen, John
AU  - Villumsen J
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Rosen, Monika
AU  - Rosen M
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Lebwohl, Mark
AU  - Lebwohl M
AD  - Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20170401
PL  - United States
TA  - Skinmed
JT  - Skinmed
JID - 101168327
RN  - 0 (Aerosols)
RN  - 0 (Drug Combinations)
RN  - 0 (Ointments)
RN  - 143NQ3779B (calcipotriene)
RN  - 826Y60901U (betamethasone-17,21-dipropionate)
RN  - 9842X06Q6M (Betamethasone)
RN  - FXC9231JVH (Calcitriol)
SB  - IM
MH  - Administration, Topical
MH  - Adult
MH  - Aerosols/therapeutic use
MH  - Betamethasone/administration & dosage/*analogs & derivatives
MH  - Calcitriol/administration & dosage/*analogs & derivatives
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Drug Combinations
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Ointments/therapeutic use
MH  - Psoriasis/*diagnosis/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2017/05/23 06:00
MHDA- 2019/07/12 06:00
CRDT- 2017/05/23 06:00
PHST- 2017/05/23 06:00 [entrez]
PHST- 2017/05/23 06:00 [pubmed]
PHST- 2019/07/12 06:00 [medline]
PST - epublish
SO  - Skinmed. 2017 Apr 1;15(2):119-124. eCollection 2017.