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NCT01614743 · ClinicalTrials.gov registry record · Phase 2
A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
A Phase 2 study, sponsored by DeNova Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01614743: Completed Phase 2 study, sponsored by DeNova Research.
NCT01614743 is a Phase 2 study that has completed, run by DeNova Research. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01614743, a Phase 2 study, has completed, sponsored by DeNova Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea. The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.
Primary Outcome
Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Interventions
- DRUG IncobotulinumtoxinA
- DRUG Bacteriostatic saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01614743 record still lists
NCT01614743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which IncobotulinumtoxinA is the first listed.
NCT01614743 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01614743 about?
NCT01614743 is a clinical study titled "A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea". This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea. The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area...
What is the current status of trial NCT01614743?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2012-06. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01614743?
The interventions under investigation include: IncobotulinumtoxinA (DRUG), Bacteriostatic saline (DRUG).
Who is sponsoring clinical trial NCT01614743?
This trial is sponsored by DeNova Research, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01614743's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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