A phase III, multicentre, randomised, observer-blind, intraindividual, paired, comparative trial to evaluate the efficacy and safety of a 0.1% mometasone furoate cutaneous emulsion compared to Ecural® fat cream and vehicle cutaneous emulsion in the treatment of adult participants with plaque psoriasis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511583-82-00

Acronym

410701BS

Enrollment

Registered

2024-08-12

Start date

2024-10-08

Completion date

2025-03-03

Last updated

2024-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis

Brief summary

Primary efficacy endpoint: % change from baseline in TSS on Day 22. Change from baseline in percent (%) is calculated as: % change=100*((TSS 22 - TSS 1) / TSS 1)

Detailed description

Secondary efficacy endpoints: % change from baseline in TSS on Day 8., Secondary efficacy endpoints: Changes from baseline in TSS on Days 8 and 22.

Interventions

DRUGMomeGalen 1 mg/g cutaneous emulsion

DRUGPlacebo to 0.1% mometasone furoate cutaneous emulsion (active ingredient-free vehicle of mometasone cutaneous emulsion)

DRUGECURAL Fettcreme

DRUG1 mg/g Creme

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: % change from baseline in TSS on Day 22. Change from baseline in percent (%) is calculated as: % change=100*((TSS 22 - TSS 1) / TSS 1)	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: % change from baseline in TSS on Day 8., Secondary efficacy endpoints: Changes from baseline in TSS on Days 8 and 22.	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026