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NCT01610596 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis
A Phase 2 study, sponsored by Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01610596: Completed Phase 2 study, sponsored by Therapeutics.
NCT01610596 is a Phase 2 study that has completed, run by Therapeutics. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610596, a Phase 2 study, has completed, sponsored by Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.
Primary Outcome
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment "success" at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale.
Interventions
- DRUG Placebo
- DRUG Halobetasol Propionate Lotion 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01610596 record still lists
NCT01610596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01610596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610596 about?
NCT01610596 is a clinical study titled "A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis". This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomize...
What is the current status of trial NCT01610596?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2011-11. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01610596?
The interventions under investigation include: Placebo (DRUG), Halobetasol Propionate Lotion 0.05% (DRUG).
Who is sponsoring clinical trial NCT01610596?
This trial is sponsored by Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610596's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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