Evidence map›Paper›PMID 27995521›Full record

Trial reportClinical drug investigation2017

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis.

Catherine Queille-Roussel, Monika Rosen, Fabrice Clonier, Kasper Nørremark, Jean-Philippe Lacour

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02518048 (A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02518048 phase2completednot on this map

A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris

TypeinterventionalSponsorLEO PharmaRan2015 to 2016Enrolled35ConditionsSkin and Connective Tissue DiseasesArmsLEO 90100 Aerosol foam, Betesil® 2.25 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

5 authors.

Catherine Queille-RousselCentre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France. catherine.queille-roussel@skinpharma.fr.
Monika RosenLEO Pharma A/S, Ballerup, Denmark.
Fabrice ClonierLEO Pharma (Laboratoires LEO), Voisins Le Bretonneux, France.
Kasper NørremarkLEO Pharma A/S, Ballerup, Denmark.
Jean-Philippe LacourCentre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas.

objectiveThe aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis.

methodsIn this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas.

resultsThirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated.

conclusionCal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis. CLINICAL TRIAL REGISTRATION NUMBER: NCT02518048.

Indexed as

AdultAerosolsBetamethasoneBetamethasone ValerateCalcitriolDermatologic AgentsFemaleGlucocorticoidsHumansMaleMiddle AgedPsoriasisSingle-Blind MethodTreatment OutcomeAerosolsBetamethasonebetamethasone-17,21-dipropionateBetamethasone ValeratecalcipotrieneCalcitriolDermatologic AgentsGlucocorticoids

Identifiers

PMID27995521
PMCPMC5346111

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Registered trials

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.