Evidence map›Paper›PMID 27313822›Full record

ArticleThe Journal of clinical and aesthetic dermatology2016

Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study.

Mark Lebwohl, Stephen Tyring, Michael Bukhalo, Javier Alonso-Llamazares, Martin Olesen, David Lowson, Paul Yamauchi

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in The Journal of clinical and aesthetic dermatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01536938 (LEO 90100 in the Treatment of Psoriasis Vulgaris), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
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.

NCT01536938 phase2completednot on this map

LEO 90100 in the Treatment of Psoriasis Vulgaris

TypeinterventionalSponsorLEO PharmaRan2012 to 2012Enrolled303ConditionsPsoriasis VulgarisArmsLEO 90100, Calcipotriol, Betamethasone
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 65 citations in OpenAlex.

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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

7 authors at 5 institutions in 2 countries.

Mark LebwohlDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York;
Stephen TyringDepartment of Dermatology, University of Texas, Houston, Texas;
Michael BukhaloAltman Dermatology Associates, Arlington Heigrits, Illinois;
Javier Alonso-LlamazaresDepartment of Dermatology, VA Medical Center, Miami, Florida;
Martin OlesenLEO Pharma A/S, Ballerup, Denmark;
David LowsonLEO Pharma A/S, Ballerup, Denmark;
Paul YamauchiDermatology Institute and Skin Care Center, Santa Monica, California.
Leo Pharma (Denmark) · DKArlington Dermatology · USIcahn School of Medicine at Mount Sinai · USMiami VA Healthcare System · USThe University of Texas Health Science Center at Houston · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD).

designPatients were randomized (100:101:101) to receive Cal/BD foam, Cal foam, or BD foam once daily for four weeks.

settingTwenty-eight United States centers.

participants302 patients (≥18 years) with Psoriasis vulgaris (plaque Psoriasis; ≥mild disease severity by physicians global assessment). MEASUREMENTS: Treatment success of the body ("clear"/"almost clear" from baseline moderate/severe disease; "clear" from baseline mild disease). Involved scalp treatment success was an additional endpoint.

resultsMost patients (76%) had moderate Psoriasis of the body (66% for scalp). At Week 4, 45 percent of Cal/BD foam patients achieved treatment success, significantly more than Cal foam (14.9%; OR 4.34 [95%CI 2.16,8.72] P<0.001) or BD foam (30.7%; 1.81 [1.00,3.26] P=0.047). Fifty-three percent of Cal/BD foam patients achieved treatment success of the scalp, significantly greater than Cal foam (35.6%; 1.91 [1.09,3.35] P=0.021), but not BD foam (47.5%; 1.24 [0.71,2.16] P=0.45). Mean modified Psoriasis area and severity index (population baseline 7.6) improved in all groups, with statistically significant differences in Week 4 Cal/BD foam score (2.37) versus Cal foam (4.39; mean difference -2.03 [-2.63][-1.43] P<0.001) and BD foam (3.37; -1.19 [-1.80][-0.59] P<0.001). Four (Cal/BD), 10 (Cal), and 8 (BD) adverse drug reactions were reported.

conclusionCal/BD foam was significantly more effective than Cal foam and BD foam in providing treatment success at Week 4 and effective on involved scalp.

trial registrationNCT01536938.

Identifiers

PMID27313822
PMCPMC4771388
OpenAlexW2431399654

What OpenQuestion holds

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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.