Evidence map›Paper›PMID 32965655›Full record

ArticleAdvances in therapy2020

PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.

Linda Stein Gold, Javier Alonso-Llamazares, Jean-Philippe Lacour, Richard B Warren, Stephen K Tyring, Leon Kircik, Paul Yamauchi, Mark Lebwohl, PSO-LONG Trial Investigators

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02899962 (LEO 90100 Twice Weekly Maintenance Regimen for 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
0.6field-weighted citation impact, top 35% 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.

NCT02899962 phase3completednot on this map

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

TypeinterventionalSponsorLEO PharmaRan2017 to 2019Enrolled722ConditionsPsoriasis VulgarisArmsLEO 90100 aerosol foam, LEO 90100 aerosol foam vehicle
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Topical proactive therapy in dermatology. A scoping review.Postepy dermatologii i alergologii · 2023
    Article
  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

9 authors at 7 institutions in 3 countries.

Linda Stein GoldDepartment of Dermatology, Henry Ford Health System, Detroit, MI, USA.
Javier Alonso-LlamazaresDepartment of Dermatology, VA Medical Center, Miami, FL, USA.
Jean-Philippe LacourDepartment of Dermatology, University Hospital of Nice, Nice, France.
Richard B WarrenDermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.
Stephen K TyringDepartment of Dermatology, University of Texas Health Science Center, Houston, TX, USA.
Leon KircikIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Paul YamauchiDivision of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Mark LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.
PSO-LONG Trial Investigators
Centre Hospitalier Universitaire de Nice · FRHenry Ford Health System · USIcahn School of Medicine at Mount Sinai · USIndiana University School of MedicineThe University of Texas Health Science Center at Houston · USUniversity of California, Los Angeles · USUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.

objectiveThe aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.

methodsOnce-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach. PLANNED OUTCOMES: Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.

trial registrationClinicalTrials.gov identifier, NCT02899962.

Indexed as

Dermatologic AgentsPsoriasisAerosolsDrug CombinationsHumansHypothalamo-Hypophyseal SystemPituitary-Adrenal SystemTreatment OutcomeAerosolsDermatologic AgentsDrug CombinationsCalcipotriol/betamethasone dipropionate (Cal/BD) foamDouble-blindEfficacyLong-term treatmentPhase 3Proactive managementPsoriasis vulgarisReboundSafety

Identifiers

PMID32965655
PMCPMC7547957
OpenAlexW3088534458

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.