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The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Treatment | Active Comparator | Treatment of facial wrinkle with one treatment only |
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| Double Treatment | Active Comparator | Treatment of facial wrinkle with two treatments |
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| Triple treatment | Active Comparator | Treatment of facial wrinkle with three treatments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelleve Wrinkle Treatment System | Device | comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System |
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| Measure | Description | Time Frame |
|---|---|---|
| Fitzpatrick Wrinkle Assessment | Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease | change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment. |
| Adverse Events | The rate of adverse events occurring in treatment subjects will be assessed. | 90 days post treatment |
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Inclusion Criteria:
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 Institute | Chichago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Treatment | Subjects receive one treatment |
| FG001 | Double Treatment | Subjects receive two treatments |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FG002 |
| Triple Treatment |
Subjects receive three treatments |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Treatment | Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System |
| BG001 | Double Treatment | Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System |
| BG002 | Triple Treatment | Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Fitzpatrick Wrinkle Assessment | Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease | Posted | Mean | Standard Deviation | units on a scale, change in Fitzpatrick | change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment. |
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| Primary | Adverse Events | The rate of adverse events occurring in treatment subjects will be assessed. | Posted | Number | number of adverse events reported | 90 days post treatment |
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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 | Single Treatment | Subjects receive one treatment | 0 | 15 | 0 | 15 | ||
| EG001 | Double Treatment | Subjects receive two treatments | 0 | 15 | 0 | 15 | ||
| EG002 | Triple Treatment | Subjects receive three treatments | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Dayan | Chicago Center for Facial Plastic Surgery | (312) 335-2070 | sdayan@drdayan.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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