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Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

NCT00216827•LEO Pharma

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis. The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Scalp psoriasis amenable to topical treatment
•Psoriasis vulgaris on trunk and/or limbs
•Extent of scalp psoriasis involving more than 10% of the total scalp area
•Disease severity on the scalp graded as mild or worse by the investigator
•Consenting out-patients of 18 years or above

Exclusion Criteria

•PUVA or Grenz ray therapy within 4 weeks prior to randomisation
•UVB therapy within 2 weeks prior to randomisation
•Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
•Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
•Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
•Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
•Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Locations (8)

FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Canada

Roskilde Hospital, Division of Dermatology

Roskilde, Denmark

Hôpital de l'Archet, Service de Dermatologie

Nice, France

Hudlegekontoret

Sandvika, Norway

Hospitais da Universidade de Coimbra, Servico de dermatologia

Coimbra, Portugal

Hospital Virgen de la Macarena, Servicio de Dermatología

Seville, Spain

Akademiska Sjukhuset, Hudkliniken

Uppsala, Sweden

Western Infirmary, Dermatology Department

Glasgow, United Kingdom

Key Dates

Start Date

November 1, 2004

Completion Date

September 1, 2005

Last Updated

February 24, 2025

Enrollment

1,485

Estimated participants

Conditions

Psoriasis of Scalp

Interventions

Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

DRUG

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

NCT04099979

PsoriasisPsoriasis Vulgaris+12 more

View study

UNKNOWN

Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines

NCT05144165

PsoriasisPsoriasis Palmaris+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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