Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis

NCT00243464 | Completed Phase 3

• 1 other identifier: MBL 0503 INT
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment. Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

Conditions

Psoriasis of Scalp

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• Total sign score at week 8

• Score for redness, thickness and scaliness at week 8

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

• Overall disease severity according to patients at week 8

• Relapse and rebound during the study

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 moderate 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
• Systemic 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 non steroid 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 (5)

Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie

Leuven, 3000, Belgium

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W5L7, Canada

Location

Department of Dermatology, Marselisborg Centres

Aarhus, 8000, Denmark

Location

Hôpital de L'Archet, Service de Dermatologie

Nice, 06202, France

Location

Läkarhuset

Gothenburg, 41135, Sweden

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; betamethasone-17,21-dipropionate

Study Officials

• Knud Kragballe, MD

  Department of Dermatology, Marselisborg Centres

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 24, 2005
• Study Start: September 1, 2005
• Study Completion: May 1, 2006
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); CA (1); DK (1); BE (1); FR (1)