PMID- 27306589
OWN - NLM
STAT- MEDLINE
DCOM- 20170414
LR  - 20240326
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Print)
IS  - 0926-9959 (Linking)
VI  - 30
IP  - 11
DP  - 2016 Nov
TI  - Enhanced vasoconstrictor potency of the fixed combination calcipotriol plus 
      betamethasone dipropionate in an innovative aerosol foam formulation vs. other 
      corticosteroid psoriasis treatments.
PG  - 1951-1956
LID - 10.1111/jdv.13714 [doi]
AB  - BACKGROUND: An aerosol foam formulation of fixed combination calcipotriol 50 mug/g 
      (Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) has been developed for 
      psoriasis vulgaris treatment. OBJECTIVE: To compare Cal/BD aerosol foam 
      pharmacodynamic activity with Cal/BD ointment and with other topical 
      corticosteroids of different potencies by assessing vasoconstrictor potential. 
      METHODS: A Phase I, single-centre, investigator-blinded, vehicle-controlled, 
      intra-individual comparison vasoconstriction study. Healthy volunteers received a 
      single application on selected sites of: Cal/BD aerosol foam, clobetasol 
      propionate 0.5 mg/g cream (CP; very potent), Cal/BD ointment (potent), 
      fluocinolone acetonide 0.25 mg/g ointment (FA; moderately potent), BD aerosol 
      foam and aerosol foam vehicle. A seventh untreated site acted as a negative 
      control. Skin blanching was assessed by visual (primary response criterion) and 
      colorimetric a* and L* measurements (secondary criteria), and was analysed over 
      time (6-32 h post-application). RESULTS: Thirty-five healthy volunteers were 
      included. All active treatments led to significantly greater skin blanching than 
      control. By visual assessment, skin blanching with Cal/BD aerosol foam was 
      significantly less compared with CP cream [mean AUC(0-32) 2560 vs. 3831; mean 
      difference = -1272; 95% confidence interval (CI): -1598, -945; P < 0.001], 
      similar to BD aerosol foam (mean AUC(0-32) 2560 vs. 2595; mean difference = -35; 
      95% CI: -362, 292; P = 0.83) and significantly greater than Cal/BD ointment (mean 
      AUC(0-32) 2560 vs. 2008; mean difference = 552; 95% CI: 225, 878; P = 0.001) and 
      FA ointment (mean AUC(0-32) 2560 vs. 1981; mean difference = 578; 95% CI: 251, 
      905; P < 0.001). Colorimetric assessments a* and L* also indicated significantly 
      reduced skin blanching with Cal/BD aerosol foam compared with CP cream. No 
      adverse events (AEs) were reported. CONCLUSION: Cal/BD aerosol foam can be 
      considered a more potent formulation than Cal/BD ointment and the moderately 
      potent FA ointment, but less potent than the very potent corticosteroid, CP 
      cream.
CI  - (c) 2016 The Authors. Journal of the European Academy of Dermatology and 
      Venereology published by John Wiley & Sons Ltd on behalf of European Academy of 
      Dermatology and Venereology.
FAU - Queille-Roussel, C
AU  - Queille-Roussel C
AD  - Centre de Pharmacologie Clinique Appliquee a la Dermatologie, Nice, France. 
      catherine.queille-roussel@skinpharma.fr.
FAU - Bang, B
AU  - Bang B
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Clonier, F
AU  - Clonier F
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Lacour, J-P
AU  - Lacour JP
AD  - Centre de Pharmacologie Clinique Appliquee a la Dermatologie, Nice, France.
AD  - Service de Dermatologie, University Hospital of Nice, Nice, France.
LA  - eng
PT  - Journal Article
DEP - 20160615
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Aerosols)
RN  - 0 (Vasoconstrictor Agents)
RN  - 143NQ3779B (calcipotriene)
RN  - 826Y60901U (betamethasone-17,21-dipropionate)
RN  - 9842X06Q6M (Betamethasone)
RN  - FXC9231JVH (Calcitriol)
SB  - IM
MH  - Adrenal Cortex Hormones/*administration & dosage
MH  - Adult
MH  - *Aerosols
MH  - Betamethasone/administration & dosage/*analogs & derivatives
MH  - Calcitriol/administration & dosage/*analogs & derivatives
MH  - Colorimetry
MH  - Humans
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
MH  - Vasoconstrictor Agents/*administration & dosage
MH  - Young Adult
PMC - PMC5108427
EDAT- 2016/10/25 06:00
MHDA- 2017/04/15 06:00
PMCR- 2016/11/14
CRDT- 2016/06/17 06:00
PHST- 2015/11/30 00:00 [received]
PHST- 2016/04/11 00:00 [accepted]
PHST- 2016/10/25 06:00 [pubmed]
PHST- 2017/04/15 06:00 [medline]
PHST- 2016/06/17 06:00 [entrez]
PHST- 2016/11/14 00:00 [pmc-release]
AID - JDV13714 [pii]
AID - 10.1111/jdv.13714 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1951-1956. doi: 10.1111/jdv.13714. 
      Epub 2016 Jun 15.