PMID- 30893392
OWN - NLM
STAT- MEDLINE
DCOM- 20190415
LR  - 20190719
IS  - 2326-6929 (Electronic)
IS  - 0011-4162 (Linking)
VI  - 103
IP  - 2
DP  - 2019 Feb
TI  - Safety and efficacy of halobetasol propionate lotion 0.01% in the treatment of 
      moderate to severe plaque psoriasis: a pooled analysis of 2 phase 3 studies.
PG  - 111-116
AB  - Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. 
      Safety concerns have limited use to 2 to 4 weeks. The objective of our study was 
      to investigate the safety and efficacy of once-daily halobetasol propionate (HP) 
      lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, 
      randomized, double-blind, vehicle-controlled phase 3 studies (N=430). 
      Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 
      weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was 
      treatment success (at least a 2-grade improvement in baseline investigator global 
      assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional 
      assessments included improvement in psoriasis signs and symptoms, body surface 
      area (BSA), and a composite score of IGAxBSA. Safety and treatment-emergent 
      adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% 
      demonstrated statistically significant superiority over vehicle as early as week 
      2 and also was superior in reducing psoriasis signs and symptoms and BSA 
      involvement.
FAU - Sugarman, Jeffrey L
AU  - Sugarman JL
AD  - University of California, San Francisco, USA.
FAU - Weiss, Jonathan S
AU  - Weiss JS
AD  - Gwinnett Dermatology, PC, and Gwinnett Clinical Research Center, Inc, Snellville, 
      Georgia, USA.
FAU - Tanghetti, Emil A
AU  - Tanghetti EA
AD  - Center for Dermatology and Laser Surgery, Sacramento, California, USA.
FAU - Soung, Jennifer
AU  - Soung J
AD  - Southern California Dermatology, Santa Ana, USA.
FAU - Yamauchi, Paul S
AU  - Yamauchi PS
AD  - David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
FAU - Lin, Tina
AU  - Lin T
AD  - Ortho Dermatologics, Bridgewater, New Jersey, USA.
FAU - Harris, Susan
AU  - Harris S
AD  - Bausch Health, Bridgewater, USA.
FAU - Martin, Gina
AU  - Martin G
AD  - Bausch Health, Petaluma, California, USA.
FAU - Pillai, Radhakrishnan
AU  - Pillai R
AD  - Bausch Health, Petaluma, California, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Dermatologic Agents)
RN  - 0 (Glucocorticoids)
RN  - 9P6159HM7T (halobetasol)
RN  - ADN79D536H (Clobetasol)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Clobetasol/administration & dosage/adverse effects/*analogs & derivatives
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Glucocorticoids/*administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy/pathology
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2019/03/21 06:00
MHDA- 2019/04/16 06:00
CRDT- 2019/03/21 06:00
PHST- 2019/03/21 06:00 [entrez]
PHST- 2019/03/21 06:00 [pubmed]
PHST- 2019/04/16 06:00 [medline]
PST - ppublish
SO  - Cutis. 2019 Feb;103(2):111-116.