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NCT01188928 · ClinicalTrials.gov registry record · Phase 3
LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,152
- Enrollment target
NCT01188928: Completed Phase 3 study, sponsored by LEO Pharma.
NCT01188928 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 1,152 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188928, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,152 participants
- Enrollment target
Study 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).
Primary Outcome
The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Interventions
- DRUG Calcipotriene
- DRUG Calcipotriol plus betamethasone
- DRUG Betamethasone-17,21-dipropionate
- DRUG Topical suspension vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,152 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT01188928 record still lists
NCT01188928 is an interventional study that assigns participants to a tested intervention. Its 1,152 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 4 interventions - of which Calcipotriene is the first listed.
NCT01188928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01188928 about?
NCT01188928 is a clinical study titled "LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)". 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 susp...
What is the current status of trial NCT01188928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,152 participants. The study started on 2010-09. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01188928?
The interventions under investigation include: Calcipotriene (DRUG), Calcipotriol plus betamethasone (DRUG), Betamethasone-17,21-dipropionate (DRUG), Topical suspension vehicle (DRUG).
Who is sponsoring clinical trial NCT01188928?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01188928's enrollment target sits among peer trials
1,152 238th of 2000 higher than 1,763 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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