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| Name | Class |
|---|---|
| Merz North America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobotulinumtoxinA | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | Experimental injection given at baseline and Week 16 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
| Number of Participants Experiencing Adverse Events | Rate of adverse events | baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Males and females between 18 and 65 years of age.
Subjects presenting with rosacea in the cheek area.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Dayan, MD | DeNova Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| DeNova Research Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | IncobotulinumtoxinA at Baseline and Week 16 | IncobotulinumtoxinA: Experimental injection given at baseline and Week 16 |
| FG001 | Placebo at Baseline, Then incobotulinumtoxinA at 16 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bacteriostatic saline |
| Drug |
Placebo at baseline, incobotulinumtoxinA at 16 weeks |
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| 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.
| week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - IncobotulinumtoxinA | Experimental injection given at baseline and Week 16 |
| BG001 | Group 2 - Bacteriostatic Saline | Placebo at baseline, incobotulinumtoxinA at 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percent change | baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
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| Primary | Number of Participants Experiencing Adverse Events | Rate of adverse events | Posted | Number | participants | baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
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| Secondary | Patient Satisfaction | 4-point categorical assessment of patient satisfaction with treatment.
| Posted | Mean | Standard Deviation | units on a scale | week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - IncobotulinumtoxinA | Experimental injection given at baseline and Week 16 | 0 | 4 | 0 | 4 | ||
| EG001 | Group 2 - Bacteriostatic Saline | Placebo at baseline, incobotulinumtoxinA at 16 weeks | 0 | 5 | 0 | 5 |
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The limitation of this study was a very small sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven H Dayan, MD | DeNova Research | 312-335-2070 | sdayan@drdayan.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| % Diff from baseline, Week 12 |
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| % Diff from baseline, Week 16 |
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| % Diff from baseline, Week 17 |
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| % Diff from baseline, Week 20 |
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