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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 is a Phase 2 study that has completed, run by DeNova Research. The registered enrollment target is 9 participants.

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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.

Interventions

  • DRUG IncobotulinumtoxinA
  • DRUG Bacteriostatic saline

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2012-06
Est. Completion 2013-11
Phase Phase 2

Sponsor

DeNova Research

18 total trials

What the Registry Record Tells You About NCT01614743

The ClinicalTrials.gov registry entry for NCT01614743 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DeNova Research, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which IncobotulinumtoxinA is the first listed.

NCT01614743 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.