Evidence map›Paper›PMID 32074665›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2020

Safety and efficacy of fixed-dose combination calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.

M Seyger, W Abramovits, M Liljedahl, M N Hoejen, J Teng

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02387853 (Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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.

NCT02387853 phase2completednot on this map

Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

TypeinterventionalSponsorLEO PharmaRan2016 to 2018Enrolled117ConditionsPsoriasis VulgarisArmsLEO 90100
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. The Burden of Pediatric Psoriasis: A Systematic Review.American journal of clinical dermatology · 2025
    Pooled it
  2. Review
  3. Review
  4. Review
  5. 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 at 4 institutions in 3 countries.

M SeygerDepartment of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID https://orcid.org/0000-0003-0516-8294
W AbramovitsDermatology Treatment & Research Centre, Dallas, TX, USA.
M LiljedahlMedical Department, LEO Pharma A/S, Ballerup, Denmark.
M N HoejenBiostatistics, LEO Pharma A/S, Ballerup, Denmark.
J TengDepartment of Dermatology, Stanford University School of Medicine, Stanford, CA, USA.
Leo Pharma (Denmark) · DKDermatology Treatment & Research Center · USRadboud University Nijmegen · NLStanford University · US

Funding

LEO Pharma A/S
6 · The paper itself

Abstract

backgroundFixed-dose combination of calcipotriol (50 μg/g; Cal) and betamethasone dipropionate (0.5 mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents.

objectivesTo evaluate safety of 4 weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)]. Systemic exposure to Cal/BD was also assessed.

methodsA phase II, open-label, study (NCT02387853) in patients (12 to <17 years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4 weeks.

resultsIn patients assigned to treatment (n = 106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0-4 weeks) in albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort) were small, transient and not considered clinically relevant. In the HPA-axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic-hormone (ACTH) challenge did not suggest disruption of the HPA-axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal.

conclusionsCal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA-axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.

Indexed as

Dermatologic AgentsPsoriasisAdolescentBetamethasoneCalcitriolChildDrug CombinationsHumansTreatment OutcomeBetamethasonebetamethasone-17,21-dipropionatecalcipotrieneCalcitriolDermatologic AgentsDrug Combinations

Identifiers

PMID32074665
PMCPMC7496170
OpenAlexW3008443236

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.