CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,152 enrolled
Drug / intervention
Calcipotriol plus betamethasone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01188928
NCT01188928Phase 3Completed

A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)

LEO Pharma·interventional·Posted Aug 26, 2010·Updated Mar 10, 2025

In Brief

A Phase 3 clinical trial evaluating Calcipotriol plus betamethasone, Betamethasone-17,21-dipropionate, and 2 other interventions for Psoriasis Vulgaris. Completed, enrolled 1,152 participants across 59 sites.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago

Interventions

Calcipotriol plus betamethasonedrug

Topical suspension once daily for up to 8 weeks.

Betamethasone-17,21-dipropionatedrug

Topical suspension once daily for up to 8 weeks.

Calcipotrienedrug

Topical suspension once daily for up to 8 weeks.

Topical suspension vehicledrug

Topical suspension once daily for up to 8 weeks.