Clinical Trial: 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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: DeNova Research

Current Primary Outcome:

• Change in Rosacea [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
  Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment
• Safety [ Time Frame: baseline ]
  Rate of adverse events
• Safety [ Time Frame: 1 week ]
  Rate of adverse events
• Safety [ Time Frame: 4 weeks ]
  Rate of adverse events
• Safety [ Time Frame: 12 weeks ]
  Rate of adverse events
• Safety [ Time Frame: 16 weeks ]
  Rate of adverse events
• Safety [ Time Frame: 17 weeks ]
  Rate of adverse events
• Safety [ Time Frame: 20 weeks ]
  Rate of adverse events

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in self-esteem [ Time Frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
  Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS) Scale
• Patient Satisfaction [ Time Frame: week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks ]
  4-point categorical assessment of patient satisfaction with treatment
• First Impression [ Time Frame: Baseline, 17 week, and 20 week visit ]
  Upon completion of all visits, active treatment subjects' Baseline, 17 week, and 20 week visit photographs will randomly assigned to one of three photography binders (A, B, and C). Each binder will then be evaluated by 100 blinded evaluators (300 evaluations in total).

Original Secondary Outcome: Same as current

Information By: DeNova Research

Dates:
Date Received: June 4, 2012
Date Started: June 2012
Date Completion: November 2014
Last Updated: September 12, 2014
Last Verified: September 2014