PMID- 19916299
OWN - NLM
STAT- MEDLINE
DCOM- 20091209
LR  - 20131121
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 84
IP  - 4 Suppl
DP  - 2009 Oct
TI  - Clobetasol propionate spray 0.05% add-on therapy to a stable regimen of biologic 
      treatment in patients with moderate to very severe plaque psoriasis.
PG  - 25-32
AB  - Moderate to severe psoriasis often requires systemic treatment, but even biologic 
      medications do not always induce complete clearing in patients. In many 
      instances, physicians supplement biologic treatment with topical agents as 
      adjunctive therapy to obtain additional clearing of plaques. To evaluate the 
      effectiveness of the addition of a superpotent corticosteroid--clobetasol 
      propionate spray 0.05%--to various psoriasis treatments, a phase 4, multicenter, 
      open-label, community-based trial was conducted. In this study, clobetasol 
      propionate spray 0.05% applied twice daily was added on to a variety of existing 
      stable treatments including systemic biologic agents in participants with 
      moderate, severe, or very severe plaque psoriasis. The decision to add clobetasol 
      propionate spray 0.05% to stable psoriasis therapy was determined by each 
      investigator based on his/her evaluation of a participant's needs. A total of 159 
      participants from the trial adhered to stable (> or = 3 months' duration) 
      therapeutic regimens that included a biologic treatment. In this population, at 
      the end of the study period, 81.0% of participants with moderate disease at 
      baseline, 79.5% of participants with severe disease at baseline, and 58.8% of 
      participants with very severe disease at baseline were rated as clear or almost 
      clear (target plaque severity [TPS]). Worst skin tolerability response was 
      assessed postbaseline and included erythema (20.3% mild, 8.9% moderate, 1.9% 
      severe), peeling (26.6% mild, 7.0% moderate, 1.3% severe), dryness (34.8% mild, 
      8.9% moderate, 1.3% severe), and stinging (25.3% mild, 3.8% moderate, 0.6% 
      severe). Telangiectasia and skin atrophy were reported in 1.3% of participants 
      each at some point during the study (postbaseline). Pruritus was reported in 7.6% 
      of participants and folliculitis was reported in 1.9% of participants. Eight 
      participants experienced adverse events (AEs) that were regarded as probably 
      related to the study medication (clobetasol propionate spray 0.05%). Because 
      those participants who entered the study already were receiving one medication 
      (the biologic agent), it is believed that most of the reported AEs were due to 
      the addition of clobetasol propionate spray 0.05%, and those AEs associated with 
      the biologic agent and/or the combination of the two may be underreported. 
      Although the results of this study are intriguing, further research is needed to 
      evaluate if the addition of topical therapies, such as superpotent 
      corticosteroids, are effective and safe options for treating psoriasis plaques 
      when control with biologic therapy is not fully effective on its own.
FAU - Feldman, Steven R
AU  - Feldman SR
AD  - Center for Dermatology Research, Department of Dermatology, Wake Forest 
      University School of Medicine, Winston-Salem, North Carolina, USA.
FAU - Koo, John Y M
AU  - Koo JY
FAU - Johnson, Lori A
AU  - Johnson LA
FAU - Preston, Norman J
AU  - Preston NJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Biological Products)
RN  - ADN79D536H (Clobetasol)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Biological Products/administration & dosage/adverse effects/*therapeutic use
MH  - Clobetasol/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy/physiopathology
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Young Adult
EDAT- 2009/11/18 06:00
MHDA- 2009/12/16 06:00
CRDT- 2009/11/18 06:00
PHST- 2009/11/18 06:00 [entrez]
PHST- 2009/11/18 06:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
PST - ppublish
SO  - Cutis. 2009 Oct;84(4 Suppl):25-32.