Evidence map›Paper›PMID 27358072›Full record

ArticleDermatology and therapy2016

Supersaturation of Calcipotriene and Betamethasone Dipropionate in a Novel Aerosol Foam Formulation for Topical Treatment of Psoriasis Provides Enhanced Bioavailability of the Active Ingredients.

Marianne Lind, Kim Troensegaard Nielsen, Line Hollesen Schefe, Kasper Nørremark, André Huss Eriksson, Hanne Norsgaard, Brian Thoning Pedersen, Karsten Petersson

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Trial
  2. Review
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  5. Article
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  7. Article
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  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. [New developments in topical pharmaceuticals].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2019
    Review
  17. New and Emerging Topical Therapies for Psoriasis and Atopic Dermatitis.The Journal of clinical and aesthetic dermatology · 2019
    Review
  18. Article
  19. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam For Scalp Psoriasis.Clinical, cosmetic and investigational dermatology · 2019
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Marianne LindLEO Pharma A/S, Ballerup, Denmark.
Kim Troensegaard NielsenLEO Pharma A/S, Ballerup, Denmark.
Line Hollesen SchefeLEO Pharma A/S, Ballerup, Denmark.
Kasper NørremarkLEO Pharma A/S, Ballerup, Denmark. kasper.noerremark@leo-pharma.com.
André Huss ErikssonLEO Pharma A/S, Ballerup, Denmark.
Hanne NorsgaardLEO Pharma A/S, Ballerup, Denmark.
Brian Thoning PedersenLEO Pharma A/S, Ballerup, Denmark.
Karsten PeterssonLEO Pharma A/S, Ballerup, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPrevious studies have demonstrated the superior efficacy of a novel aerosol foam formulation of fixed combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD), compared with the ointment formulation. The aim of this study is to ascertain whether enhanced bioavailability of the active ingredients due to supersaturation and/or occlusive properties can explain the observed greater clinical efficacy.

methodsSolubility and evaporation experiments were conducted to examine the abilities of Cal/BD aerosol foam ingredients to create a supersaturated environment. Optical microscopy, Raman imaging and X-ray powder diffraction were used to examine the physical state of Cal and BD in the formulations after application, and determine whether a supersaturated state remained stable for clinically relevant time periods. In vitro skin penetration and ex vivo biomarker assays were conducted to compare the skin penetration and bioavailability of Cal and BD from the aerosol foam and ointment formulations, respectively. Occlusive properties were examined via transepidermal water loss.

resultsSolubility studies showed that Cal and BD solubility increased with increasing dimethyl ether (DME) content. Both active ingredients are completely dissolved in the final aerosol foam formulation. DME rapidly evaporates after spraying, and the amount was reduced to 0.5% of the initial amount after 2 min. This led to the formation of a supersaturated environment, where Cal and BD crystals were absent for at least 26 h after application. Cal/BD aerosol foam had significantly greater in vitro skin penetration and had increased bioavailability compared with Cal/BD ointment. Both formulations effectively occluded the skin.

conclusionA stable supersaturated solution of Cal/BD in the aerosol foam leads to increased bioavailability and explains the improved clinical effect when compared to the Cal/BD ointment.

fundingThe studies included in the paper are all conducted by LEO Pharma A/S or CROs on behalf of LEO Pharma A/S.

Indexed as

Aerosol foamBetamethasone dipropionateCalcipotrieneCutaneous foamEfficacyPsoriasisRaman imagingSkin penetrationSupersaturationTopical treatments

Identifiers

PMID27358072
PMCPMC4972731

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.