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OpenTrials
Completed

NCT Number: NCT00216827

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

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.

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Key information

Conditions

Psoriasis of Scalp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain, Québec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 mild 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
  • 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

Treatment and study plan

Calcipotriol plus betamethasone dipropionate (LEO80185 gel)

Drug

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 scaliness, redness and thickness at week 8

  3. Extent of scalp psoriasis at week 8

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

  5. Overall disease severity according to patients at week 8

  6. Adverse events

  7. Laboratory data

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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