NCT01614743

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: DeNova Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA	Experimental injection given at baseline and Week 16
DRUG	Bacteriostatic saline	Placebo at baseline, incobotulinumtoxinA at 16 weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-06-08
• Last updated: 2020-10-08
• Results posted: 2020-09-14

Locations

1 site across 1 country: United States