Evidence map›Paper›PMID 29204958›Full record

ArticleClinical drug investigation2018

Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis.

Edward Lain, Torsten Skov, Anders Hall

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02424305 (Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing 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.

NCT02424305 phase1completednot on this map

Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

TypeinterventionalSponsorLEO PharmaRan2015 to 2015Enrolled60ConditionsActinic KeratosisArmsLEO 43204 gel 0.018%, LEO 43204 gel 0.1%, LEO 43204 gel 0.037%
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

3 authors.

Edward LainAustin Institute for Clinical Research, 302 N Heatherwilde Boulevard #200, Pflugerville, TX, 78660, USA. ted.lain@atxderm.com.ORCID http://orcid.org/0000-0002-0762-1251
Torsten SkovLEO Pharma A/S, Ballerup, Denmark.
Anders HallLEO Pharma A/S, Ballerup, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesIngenol disoxate (LEO 43204) is a field therapy in development for the treatment of actinic keratosis (AK) on areas between 25 and 250 cm

methodsThis was a phase I, open-label, non-randomized, multicenter trial. Patients ≥ 18 years of age with ≥ 15 clinically typical, visible, discrete AK lesions in a treatment area on the full face or approximately 250 cm

resultsThe trial included 58 patients. Median age (range) of patients was 68 years (42-89) [face, N = 18], 66 years (43-88) [arm, N = 21], and 67 years (37-83) [scalp, N = 19]. The highest quantifiable ingenol disoxate level was observed in the arm group (0.33 nM, area under the concentration-time curve from time zero to the last data point [AUC

conclusionVery low systemic exposure to ingenol disoxate was observed when applied to the face, arm, or scalp in patients with AK under maximum-use conditions. No new safety signals were identified.

trial registrationNCT02424305.

Indexed as

AdultAgedAged, 80 and overDiterpenesFemaleGelsHumansKeratosis, ActinicMaleMiddle AgedPainPruritusTreatment OutcomeDiterpenesGelsingenolLEO 43204

Identifiers

PMID29204958

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