Overview

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

Status:
Completed

Trial end date:
2013-11-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

DeNova Research

Collaborators:

Merz North America, Inc.
Merz Pharmaceuticals, LLC

Treatments:

abobotulinumtoxinA
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA