Evidence map›Paper›PMID 41406959›Full record

ArticleBritish journal of clinical pharmacology2026

Maximal use of 0.05% topical isotretinoin in patients with congenital ichthyosis results in low systemic exposure.

Holm Schneider, Christopher G Bunick, Kathrin Hillmann, Thy N Huynh, Steven Kempers, Nicolai Peschel, Ulrike Blume-Peytavi, Joyce M C Teng, Alan M Mendelsohn, John Stinson and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05295732 (The ASCEND Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05295732 phase3completednot on this map

The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - With a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (X-linked) or ARCI Ichthyosis in Subjects Aged ≥6 Years

TypeinterventionalSponsorLEO PharmaRan2022 to 2024Enrolled153ConditionsIchthyosisArmsTMB-001, Matching Vehicle
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

11 authors.

Holm SchneiderDepartment of Pediatrics, University Hospital Erlangen, Erlangen, Germany.ORCID https://orcid.org/0000-0002-8548-4053
Christopher G BunickDepartment of Dermatology, Yale School of Medicine, New Haven, Connecticut, USA.
Kathrin HillmannDepartment of Dermatology, Venereology and Allergology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Thy N HuynhDepartment of Dermatology, University of Mississippi, Jackson, Mississippi, USA.
Steven KempersAssociated Skin Care Specialists, New Brighton, Minnesota, USA.
Nicolai PeschelDepartment of Pediatrics, University Hospital Erlangen, Erlangen, Germany.
Ulrike Blume-PeytaviDepartment of Dermatology, Venereology and Allergology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Joyce M C TengDepartment of Dermatology, Stanford University School of Medicine, Palo Alto, California, USA.
Alan M MendelsohnTimber Pharmaceuticals, LEO Pharma Company, Madison, New Jersey, USA.
John StinsonLEO Pharma A/S, Ballerup, Denmark.
Lara Wine LeeDepartment of Dermatology, Medical University of South Carolina, Charleston, South Carolina, USA.

Funding

LEO Pharma A/STimber Pharmaceuticals
6 · The paper itself

Abstract

Congenital ichthyoses (CI) are rare, inherited skin disorders characterized by hyperkeratosis, scaling and fissuring that significantly impair patients' quality of life. Treatment options are limited, with systemic retinoids reserved for severe cases owing to their adverse effect profile. This open-label, single-arm, maximal-use trial investigated the systemic exposure and safety of a topically administered isotretinoin ointment (TMB-001 0.05%) in patients with moderate-to-severe CI. Thirty-four patients aged ≥6 years applied TMB-001 0.05% under maximal-use conditions (twice daily to 75%-90% of the body surface area) for 14 days, with continued application for another 10 weeks. Exposure levels for TMB-001 0.05% and its metabolites were < 1% of those observed after single oral administration of 80 mg isotretinoin to healthy adults. A majority of patients had local safety or tolerability issues, most of which were mild. Overall, the treatment was well tolerated with no evidence of systemic toxicity.

Indexed as

Dermatologic AgentsIsotretinoinAdministration, CutaneousAdministration, TopicalAdolescentAdultAgedChildFemaleHumansMaleMiddle AgedOintmentsTreatment OutcomeYoung AdultDermatologic AgentsIsotretinoinOintmentsARCIpharmacokineticsretinoidsRXLITMB‐001

Identifiers

PMID41406959
PMCPMC13021285

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.