PMID- 30365586
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20181211
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 17
IP  - 10
DP  - 2018 Oct 1
TI  - Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the 
      Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 
      Randomized Controlled Trials.
PG  - 1062-1069
AB  - BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis 
      treatment; long-term safety concerns limiting consecutive use of potent TCS to 
      2-4 weeks. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 
      0.01% lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, 
      randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects 
      randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 
      8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment 
      success (at least a 2-grade improvement from baseline in Investigator Global 
      Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and 
      treatment emergent adverse events (AEs) evaluated throughout. RESULTS: 
      Halobetasol propionate 0.01% lotion demonstrated statistically significant 
      superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% 
      (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on 
      vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also 
      superior in reducing psoriasis signs and symptoms, body surface area (BSA), and 
      improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated 
      with no treatment-related AEs greater than 1%. LIMITATIONS: Study did not include 
      subjects with BSA greater than 12. CONCLUSIONS: Halobetasol propionate 0.01% 
      lotion was associated with significant reductions in the severity of the clinical 
      signs of psoriasis, without the safety concerns of a longer treatment course. J 
      Drugs Dermatol. 2018;17(10):1062-1069.
FAU - Green, Lawrence J
AU  - Green LJ
FAU - Kerdel, Francisco A
AU  - Kerdel FA
FAU - Cook-Bolden, Fran E
AU  - Cook-Bolden FE
FAU - Bagel, Jerry
AU  - Bagel J
FAU - Lin, Tina
AU  - Lin T
FAU - Martin, Gina
AU  - Martin G
FAU - Pillai, Radhakrishnan
AU  - Pillai R
FAU - Israel, Robert
AU  - Israel R
FAU - Ramakrishna, Tage
AU  - Ramakrishna T
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 9P6159HM7T (halobetasol)
RN  - ADN79D536H (Clobetasol)
SB  - IM
MH  - Administration, Cutaneous
MH  - Clobetasol/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Dermatologic Agents/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy/pathology
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
MH  - Skin Cream
MH  - Treatment Outcome
MH  - United States
EDAT- 2018/10/27 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/10/27 06:00
PHST- 2018/10/27 06:00 [entrez]
PHST- 2018/10/27 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
AID - S1545961618P1062X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2018 Oct 1;17(10):1062-1069.