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CompletedNCT00243464Updated Feb 24, 2025

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

A Phase 3 interventional study of Calcipotriol plus betamethasone dipropionate (LEO80185 gel) in Psoriasis of Scalp, sponsored by LEO Pharma. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Psoriasis of Scalp

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 300 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main 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 moderate or worse by the investigator
  • Consenting out-patients of 18 years or above

Main Exclusion Criteria:

  • 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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
300 participants

Interventions

  • DrugCalcipotriol plus betamethasone dipropionate (LEO80185 gel)
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What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Total sign score at week 8

  2. Score for redness, thickness and scaliness at week 8

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

  4. Overall disease severity according to patients at week 8

  5. Relapse and rebound during the study

07

Study locations

5 sites
  • Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie
    Leuven, 3000, Belgium
  • Windsor Clinical Research Inc.
    Windsor, Ontario N8W5L7, Canada
  • Department of Dermatology, Marselisborg Centres
    Aarhus, 8000, Denmark
  • Hôpital de L'Archet, Service de Dermatologie
    Nice, 06202, France
  • Läkarhuset
    Göteborg, 41135, Sweden
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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00243464
Lead sponsor
LEO Pharma
First posted
Oct 24, 2005
Start date
Sep 2005
Completion
May 2006
Last update
Feb 24, 2025

Study contacts

Knud Kragballe, MD
principal investigator · Department of Dermatology, Marselisborg Centres
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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