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

NCT00216827 | Completed Phase 3

• 1 other identifier: MBL 0405 INT
• Study Type: interventional
• Target: 1,485
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

Psoriasis of Scalp

Outcome Measures

Primary Outcomes (1)

• Overall disease severity according to investigator's assessment at week 8

Secondary Outcomes (7)

• Total sign score at week 8

• Score for scaliness, redness and thickness at week 8

• Extent of scalp psoriasis at week 8

• Overall disease severity according to investigator's assessment at week 2 and 4

• Overall disease severity according to patients at week 8

Interventions

Calcipotriol plus betamethasone dipropionate (LEO80185 gel) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (8)

FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, G1V 4X7, Canada

Location

Roskilde Hospital, Division of Dermatology

Roskilde, 4000, Denmark

Location

Hôpital de l'Archet, Service de Dermatologie

Nice, 06202, France

Location

Hudlegekontoret

Sandvika, 1338, Norway

Location

Hospitais da Universidade de Coimbra, Servico de dermatologia

Coimbra, 3000-075, Portugal

Location

Hospital Virgen de la Macarena, Servicio de Dermatología

Seville, 41009, Spain

Location

Akademiska Sjukhuset, Hudkliniken

Uppsala, 751 85, Sweden

Location

Western Infirmary, Dermatology Department

Glasgow, G11 6NT, United Kingdom

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; betamethasone-17,21-dipropionate

Study Officials

• Gregor Jemec, MD

  Roskilde Hospital, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2004
• Study Completion: September 1, 2005
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); CA (1); FR (1); SE (1); PT (1); DK (1); GB (1); ES (1)