Evidence map›Paper›PMID 28236223›Full record

Trial reportAmerican journal of clinical dermatology2017

Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.

Carle Paul, Craig Leonardi, Alan Menter, Kristian Reich, Linda Stein Gold, Richard B Warren, Anders Møller, Mark Lebwohl

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of clinical dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02132936 (LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02132936 phase3completednot on this map

LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

TypeinterventionalSponsorLEO PharmaRan2014 to 2015Enrolled504ConditionsPsoriasis VulgarisArmsLEO 90100 aerosol foam, Aerosol foam vehicle, Calcipotriol BDP gel, Gel vehicle
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Carle PaulPaul Sabatier University and Larrey Hospital, Toulouse, France.
Craig LeonardiSaint Louis University School of Medicine, St. Louis, MO, USA.
Alan MenterBaylor University Medical Center, Dallas, TX, USA.
Kristian ReichDermatologikum Hamburg and SCIderm GmbH, Hamburg, Germany.
Linda Stein GoldHenry Ford Health System, Detroit, MI, USA.
Richard B WarrenThe Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Anders MøllerLEO Pharma A/S, Ballerup, Denmark.
Mark LebwohlDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, 5 E 98th St, New York, NY, 10029, USA. lebwohl@aol.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy.

objectiveThe objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study.

methodsPatients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index.

resultsSeventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001).

conclusionCal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS. GOV IDENTIFIER: NCT02132936.

Indexed as

Administration, CutaneousAdultAerosolsAgedBetamethasoneCalcitriolDermatologic AgentsDrug CombinationsFemaleGelsHumansMaleMiddle AgedProspective StudiesPsoriasisQuality of LifeAerosolsBetamethasonebetamethasone-17,21-dipropionatecalcipotrieneCalcitriolDermatologic AgentsDrug CombinationsGels

Identifiers

PMID28236223
PMCPMC5422452

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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.