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The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Framed Tip | Active Comparator | Treatment with Thermage CPT Framed Tip |
|
| Pattern Tip | Experimental | Treatment with the Thermage CPT Pattern Tip |
|
| Pattern Tip Group 2 | Experimental | Treatment with the Thermage CPT Pattern tip |
|
| Total Tip | Experimental | Treatment with the Thermage CPT Total tip |
|
| Framed and Patterned Tip | Experimental | Split face treatment with the Thermage CPT Framed and Patterned tips |
|
| Total and Patterned Tip | Experimental | Split face treatment with the Thermage CPT Total and Patterned tips |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermage CPT | Device | Treatment with Thermage patterned, total, or framed tip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Laxity | Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Skin Laxity (Subject Self-assessed) | Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Wheeland, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Solta Medical Aesthetic Center | Hayward | California | 94545 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Framed Tip | Treatment with Thermage CPT Framed Tip |
| FG001 | Pattern Tip | Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique |
| FG002 | Pattern Tip Group 2 | Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique |
| FG003 | Total Tip | Treatment with the Thermage CPT Total tip |
| FG004 | Framed and Patterned Tip | Split face treatment with the Thermage CPT Framed and Patterned tips |
| FG005 | Total and Patterned Tip | Split face treatment with the Thermage CPT Total and Patterned tips |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Framed Tip | Treatment with Thermage CPT Framed Tip |
| BG001 | Pattern Tip | Treatment with the Thermage CPT Pattern Tip |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Improvement in Laxity | Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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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 | Framed Tip | Treatment with Thermage CPT Framed Tip Thermage CPT: Treatment with Thermage patterned, total, or framed tip |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment | Unrelated to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surface irregularity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Programs | Solta Medical | 510-259-5284 | aloncaric@solta.com |
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| 6 months |
| Subject Satisfaction With Treatment Results | subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 - Very Satisfied, 4 - Satisfied, 3 - Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 - Very Dissatisfied. Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied'). | 6 months |
| Withdrawal by Subject |
|
| BG002 | Pattern Tip Group 2 | Treatment with the Thermage CPT Pattern tip |
| BG003 | Total Tip | Treatment with the Thermage CPT Total tip |
| BG004 | Framed and Patterned Tip | Split face treatment with the Thermage CPT Framed and Patterned tips |
| BG005 | Total and Patterned Tip | Split face treatment with the Thermage CPT Total and Patterned tips |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Fasil Laxity Scale | (Fasil Laxity Scale: 0 = absent - 5 = severe) | Mean | Standard Deviation | units on a scale |
|
| Pattern Tip Group 2 |
Treatment with the Thermage CPT Pattern tip |
| OG003 | Total Tip | Treatment with the Thermage CPT Total tip |
| OG004 | Framed and Patterned Tip | Split face treatment with the Thermage CPT Framed and Patterned tips |
| OG005 | Total and Patterned Tip | Split face treatment with the Thermage CPT Total and Patterned tips |
|
|
| Secondary | Improvement in Skin Laxity (Subject Self-assessed) | Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Subject Satisfaction With Treatment Results | subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 - Very Satisfied, 4 - Satisfied, 3 - Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 - Very Dissatisfied. Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied'). | Posted | Number | percentage of subjects satisfied | 6 months |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Pattern Tip | Treatment with the Thermage CPT Pattern Tip Thermage CPT: Treatment with Thermage patterned, total, or framed tip | 1 | 10 | 6 | 10 |
| EG002 | Pattern Tip Group 2 | Treatment with the Thermage CPT Pattern tip Thermage CPT: Treatment with Thermage patterned, total, or framed tip | 0 | 10 | 1 | 10 |
| EG003 | Total Tip | Treatment with the Thermage CPT Total tip Thermage CPT: Treatment with Thermage patterned, total, or framed tip | 1 | 10 | 6 | 10 |
| EG004 | Framed and Patterned Tip | Split face treatment with the Thermage CPT Framed and Patterned tips Thermage CPT: Treatment with Thermage patterned, total, or framed tip | 0 | 5 | 2 | 5 |
| EG005 | Total and Patterned Tip | Split face treatment with the Thermage CPT Total and Patterned tips Thermage CPT: Treatment with Thermage patterned, total, or framed tip | 0 | 5 | 1 | 5 |
|
| Exploratory Vaginal Surgery | Surgical and medical procedures | Non-systematic Assessment | Unrelated to treatment |
|
| Intermittent itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Mild discomfort in treatment area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Jawline sensitivity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to treatment |
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| Tooth infection | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Cellular atypia | Reproductive system and breast disorders | Non-systematic Assessment | Unrelated to treatment |
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| Gout | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Bruise due to fall | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to treatment |
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| Erythema due to scratch | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to treatment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to treatment |
|
| hydronephrosis | Renal and urinary disorders | Non-systematic Assessment | Unrelated to treatment |
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| Pancreatitis | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment | Unrelated to treatment |
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| Gum grafting | Surgical and medical procedures | Non-systematic Assessment | Unrelated to treatment |
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| Rash due to sunscreen | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to treatment |
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| Accidental injestion of marijuana | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Seasonal allergies | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to treatment |
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| Fatigue | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Dental procedure | Surgical and medical procedures | Non-systematic Assessment | Unrelated to treatment |
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| Hangnail infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to treatment |
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| Sleep apnea | General disorders | Non-systematic Assessment | Unrelated to treatment |
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| Hashimoto's disease | Endocrine disorders | Non-systematic Assessment | Unrelated to treatment |
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| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment | Unrelated to treatment |
|
| Headache | General disorders | Non-systematic Assessment | Unrelated to treatment |
|
Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Prior to submission for publication or presentation, all draft manuscripts must be submitted, reviewed and approved by Sponsor for confidential material.