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
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|ClinicalTrials.gov Identifier: NCT01614743|
Recruitment Status : Unknown
Verified September 2014 by Steven H. Dayan, DeNova Research.
Recruitment status was: Active, not recruiting
First Posted : June 8, 2012
Last Update Posted : September 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Rosacea||Drug: IncobotulinumtoxinA Drug: Bacteriostatic saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Rosacea|
|Study Start Date :||June 2012|
|Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||November 2014|
Experimental injection given at baseline and Week 16
|Placebo Comparator: Placebo||
Drug: Bacteriostatic saline
Placebo at baseline, incobotulinumtoxinA at 16 weeks
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614743
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Steven H Dayan, MD||DeNova Research|