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

NCT00248456 | Completed Phase 4

• 1 other identifier: EX 0501 CN
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

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

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

• Physician's Global Assessment at the end of week 4

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

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

Interventions

Calcipotriol plus betamethasone dipropionate ointment DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Fudan University First Hospital, Dermatology Department

Shanghai, 200040, China

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

• Zheng Zhi Zhong, Professor

  Fudan University First Hospital, Dermatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2005
• Study Completion: February 1, 2006
• Last Updated: February 24, 2025

Record last verified: 2008-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)