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A multicentre, randomized, double-blind, safety and efficacy non-inferiority, intra-individual study, comparing Mometasone furoate Galenica 0.1% cream with Elocon 0.1% cream and placebo in patients with mild to moderate plaque psoriasis.

A multicentre, randomized, double-blind, safety and efficacy non-inferiority, intra-individual study, comparing Mometasone furoate Galenica 0.1% cream with Elocon 0.1% cream and placebo in patients with mild to moderate plaque psoriasis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016827-72-SE
Enrollment
Unknown
Registered
2009-11-24
Start date
2010-01-12
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Mild to moderate plaque psoriasis

Interventions

Product Name: Mometasonfuroat Galenica Product Code: GAL-Moa Pharmaceutical Form: Cream INN or Proposed INN: Mometasone furoate CAS Number: 83919-23-7 Other descriptive name: MOMETASONE FUROATE Concen

Sponsors

Galenica AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patient must voluntarily give written informed consent. -Men or women 18 years old or above. -Diagnosis of mild to moderate stable plaque proriasis (PASI score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient has neglected the wash-out period of other psoriasis treatments on the lesions to be studied. -Any other form of psoriasis other than plaque psoriasis or non-treated mild psoriasis arthritis. -Any other active skin disease, other dermatological condition or bacterial, viral, fungal skin infection. -Treatment with systemic or locally acting medications, which might counter or influence the study aims, within 2 weeks before the beginning of the study.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of the study is to show that Mometasone furoate Galenica 0.1% cream has an effect comparable with that of Elocon 0.1% cream in patients with mild to moderate plaque psoriasis (PASI of < 10) using a non-inferiority study design. The efficacy of the Elocon 0.1% cream will be compared to the efficacy of placebo in order to assess the assay sensitivity of the study design.;Secondary Objective: The secondary objectives are supporting evidence of efficacy and assessment of safety by a comparison between the Mometasone furoate Galenica 0.1% cream and the Elocon 0.1% cream.;Primary end point(s): Total Severity (TSS) score to be assessed at each visit by the investigator on each of the study lesions.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026