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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
Experimental injection given at baseline and Week 16
Placebo at baseline, incobotulinumtoxinA at 16 weeks
DeNova Research
Chicago, Illinois, United States
Percent Change From Baseline in the Rosacea Clinical Score Card
Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Number of Participants Experiencing Adverse Events
Rate of adverse events
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS) Scale. Heatherton \& Polivy State Self-Esteem (HPSS) Scale includes three facets of self-esteem: Appearance, Performance, and Social The scale has a range of 20-100. A score closer to 100 signifies higher self-esteem, while a score closer to 20 signifies lower seld-esteem.
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Patient Satisfaction
4-point categorical assessment of patient satisfaction with treatment. 1. Highly Satisfied- Optimal cosmetic result 2. Very Satisfied- Obvious improvement in appearance form the initial condition, but not completely optimal for this subject 3. Satisfied- Marked improvement in appearance from initial condition 4. Unsatisfied- The appearance is essentially the same or worse as the original condition.
Time frame: week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
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