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NCT Number: NCT00248456

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Ointment in Patients With Psoriasis Vulgaris

This study will evaluate the efficacy and safety of calcipotriol plus betamethasone dipropionate ointment compared with calcipotriol ointment in the treatment of patients with psoriasis vulgaris for a duration of 4 weeks. The study will focus on the percentage change of the psoriasis area and severity index (PASI) from baseline to the end of week 4.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fudan University First Hospital, Dermatology Department

Shanghai, 200040, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of psoriasis vulgaris in a stable condition
  • Extent of at least 10% of one or more body regions
  • Amenable to topical therapy with maximum of 100 g/week of investigational product

Exclusion criteria

  • Patients with more than 30% of body surface area involved
  • Patients with facial psoriasis who need treatment
  • Patients who need treatment of scalp psoriasis with WHO group IV topical corticosteroids, tretinoin or topical vitamin D derivatives
  • Patients with unstable forms of psoriasis including guttate, erythrodermic, pustular, or arthritis psoriasis
  • Systemic treatment of psoriasis with corticosteroids or other therapy
  • Systemic antipsoriatic treatment (e.g. corticosteroids, immunosuppressive drugs, tretinoin, antibiotics, phototherapy or calcium agents) within 4 weeks prior to visit 1; or topical antipsoriatic treatment (e.g. keratolytics, topical corticosteroids, topical vitamin D derivatives, anthralin, crude coal tar, etc) within the previous 2 week period
  • Patients with planned exposure to phototherapy that may affect the psoriasis during the study period

Treatment and study plan

Calcipotriol plus betamethasone dipropionate ointment

Drug

Primary outcomes

  1. The percentage change of PASI at the end of week 4 compared with baseline

Secondary outcomes

  1. The change of PASI at the end of week 4 compared with baseline

  2. The change of Dermatology Life Quality Index at the end of week 4 compared with baseline

  3. Physician's Global Assessment at the end of week 4

  4. Patient's assessment by Visual Analogue Scale (VAS) at the end of week 4

  5. The change of individual scores of redness, thickness, and scaliness at the end of week 4 on the target lesion compared with baseline

  6. The change of overall lesion area percentage (scalp and face area excluded) at the end of week 4 compared with baseline

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Randomised, Double-blind, Active-controlled, Parallel, Multi-center Study to Investigate the Efficacy and Safety of Daivobet® Ointment in Patients With Psoriasis Vulgaris

Important dates

Study start
2005
Study completion
2006
First posted
Nov 4, 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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