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The human skin aging process is characterized by thinning dermis, atrophy of the extracellular matrix, and reduced collagen synthesis. Loss of collagen in the dermis is of aesthetic concern, as it is the main structural support in the dermis and its loss results in skin laxity. Photo-damaged skin, mostly due to UVR, causes degradation of elastic fibers. This is histologically seen as disorganized tangles of elastin. Additionally, as humans age, skin tends to appear more dry due to its poor hydration and turgor capacity. The use of minimally invasive aesthetic treatments in reducing signs of aging has been gaining in popularity over surgical treatments in recent years. Several energy types including, laser, radiofrequency, infrared, and ultrasound, have been developed for facial rejuvenation. These treatments induce controlled thermal damage into the dermis and cause collagen contraction and neocollagenesis resulting in skin tightening over several months. For improving appearance of other anatomical areas, micro-focused ultrasound has been the preferred method, but has shown limited success in tightening the suprapatellar skin.
As with facial skin aging, the suprapatellar skin loses elasticity with age and begins to sag. Noninvasive treatments used for the face may also be used in other anatomical areas to produce the same effects of tightening. Minimally invasive bipolar radiofrequency produces a controlled thermal injury in a fractional manner without damaging the dermal-epidermal junction, epidermis or subcutis. Radiofrequency, unlike lasers, are chromophore-independent providing better penetration than lasers, and spare sweat glands, sebaceous glands, and hair follicles.
The Profound System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be hypothesized that bipolar fractional radiofrequency will stimulate similar effect on suprapatellar skin, lifting and reducing laxity of the skin in that region.
This study intends to evaluate the effectiveness of the Profound System on suprapatellar skin, which has been FDA approved for treatment of facial wrinkles and improvement in the appearance of cellulite. This device is a well studied and frequently used on facial skin, however, there are no studies showing its effectiveness elsewhere on the body.
There are alternative treatments that have been shown to decrease laxity of the suprapatellar skin, however, the studies include a small and limited population, and have not produced the desired effects in practice. The Profound device may be able to produce clinically significant improvement in laxity of the suprapatellar skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All patients will undergo treatment with Profound system device. Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound system | Device | Profound system is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be hypothesized that bipolar fractional radiofrequency will stimulate similar effect on suprapatellar skin, lifting and reducing laxity of the skin in that region. Bilateral suprapatellar regions will be identified and marked for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Knee Laxity and Texture Evaluation | Photographs will be used to evaluate efficacy of treatment. The photographs from final visit will be compared to their baseline photographs and visually evaluated by the study team. The study team will assess the laxity from baseline to 6 months. | baseline and 6 months |
| Epidermal Thickness | Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | baseline, 7 Days, 3 Weeks, 3 Months and 6 Months |
| Dermal Thickness | Dermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Baseline, 7 Days, 3 Weeks, 3 Months and 6 Months |
| Change in Blood Flow at 0.25mm | Blood Flow will be measured via optical coherence tomography prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. | Baseline, Day 7, Week 3 Month 3 and Month 6 |
| Transepidermal Water Loss | Transepidermal Water Loss will be masured via Aquaflux prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Baseline, Day 7, Week 3, Month 3 and Month 6 |
| Skin Elasticity | Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | Chair & Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27020864 | Background | Tobin DJ. Introduction to skin aging. J Tissue Viability. 2017 Feb;26(1):37-46. doi: 10.1016/j.jtv.2016.03.002. Epub 2016 Mar 14. | |
| 19143021 | Background | Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B. Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis. Lasers Surg Med. 2009 Jan;41(1):1-9. doi: 10.1002/lsm.20731. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | All patients will undergo treatment with Profound system device (bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Photographic Knee Laxity and Texture Evaluation | Photographs will be used to evaluate efficacy of treatment. The photographs from final visit will be compared to their baseline photographs and visually evaluated by the study team. The study team will assess the laxity from baseline to 6 months. | Reviewers were asked to evaluate the visible change in texture and laxity on a scale of 1-3. Worsened (1), No Change (2) and Improved (3). | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 months |
|
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 | Treatment | All patients will undergo treatment with Profound system device (microneedles and thermal heat to stimulate neocollagenesis). Using the radiofrequency and temperature setting within the FDA approved limits (460 +/- 5kHz and 65-75°C +/- 1°C), patients will be treated one time over the entire suprapatellar region bilaterally and followed for a 6 month period. The acute effect of the radiofrequency application will be determined by subjective and objective analysis using standard, close-up, 3D, cross-polarized, high resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, and/or BTC 2000 measurements. Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will allow investigators to correlate changes seen in skin measurements with histology and gene expression. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | Skin and subcutaneous tissue disorders | Tenderness | Systematic Assessment | Event reported at Day 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Barillas | UT Southwestern | 214-645-8907 | jennifer.barillas@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2018 | Oct 6, 2020 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2018 | Oct 6, 2020 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| Baseline, Day 7, Week 3, Months 3 and Months 6 |
| Change in Skin Laxity | BTC2000 will be used to measure skin laxity prior to treatment and post treatment. The BTC2000 is a non-invasive device that measures skin laxity by creating a negative pressure against the skin and calculates laxity when the pressure is released. | baseline, 7 days, 3 weeks, 3 months and 6 months |
| Histological Analysis- Collagen 1 | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. | Baseline. Day 7 and 3 Months |
| Gene Expression- Collagen 1 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change was calculated at each time point past baseline. Fold change = sample/average of the baseline. | Day 7, Month 3 |
| Epidermal Density | Epidermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Baseline, Day 7, Week 3, Month 3 and Month 6 |
| Histological Analysis- Collagen 3 | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. Sample/Average of the baseline. | Baseline, Day 7, Month 3 |
| Histological Analysis- Elastin | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. Samples/Average of the baseline | Baseline, Day 7, Month 3 |
| Gene Expression- Collagen 3 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Day 7, Month 3 |
| Gene Expression- Elastin | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Day 7, Month 3 |
| Gene Expression- Interluekin 6 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Day 7, Month 3 |
| 22268509 | Background | Alster TS, Tanzi EL. Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound. Dermatol Surg. 2012 May;38(5):754-9. doi: 10.1111/j.1524-4725.2012.02338.x. Epub 2012 Jan 23. |
| 23278964 | Background | Alexiades-Armenakas M, Newman J, Willey A, Kilmer S, Goldberg D, Garden J, Berman D, Stridde B, Renton B, Berube D, Hantash BM. Prospective multicenter clinical trial of a minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid and laxity treatment. Dermatol Surg. 2013 Feb;39(2):263-73. doi: 10.1111/dsu.12065. Epub 2012 Dec 28. |
| 27490716 | Background | Gold M, Taylor M, Rothaus K, Tanaka Y. Non-insulated smooth motion, micro-needles RF fractional treatment for wrinkle reduction and lifting of the lower face: International study. Lasers Surg Med. 2016 Oct;48(8):727-733. doi: 10.1002/lsm.22546. Epub 2016 Aug 4. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Epidermal Thickness | Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | mm | baseline, 7 Days, 3 Weeks, 3 Months and 6 Months |
|
|
|
| Primary | Dermal Thickness | Dermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | mm | Baseline, 7 Days, 3 Weeks, 3 Months and 6 Months |
|
|
|
| Primary | Change in Blood Flow at 0.25mm | Blood Flow will be measured via optical coherence tomography prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Deviation | mm/s | Baseline, Day 7, Week 3 Month 3 and Month 6 |
|
|
|
| Primary | Transepidermal Water Loss | Transepidermal Water Loss will be masured via Aquaflux prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | g/(m2h) | Baseline, Day 7, Week 3, Month 3 and Month 6 |
|
|
|
| Primary | Skin Elasticity | Skin Elasticity will be measured via BTC2000 prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | mm | Baseline, Day 7, Week 3, Months 3 and Months 6 |
|
|
|
| Primary | Change in Skin Laxity | BTC2000 will be used to measure skin laxity prior to treatment and post treatment. The BTC2000 is a non-invasive device that measures skin laxity by creating a negative pressure against the skin and calculates laxity when the pressure is released. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Deviation | mm | baseline, 7 days, 3 weeks, 3 months and 6 months |
|
|
|
| Primary | Histological Analysis- Collagen 1 | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | fluorescence intensity | Baseline. Day 7 and 3 Months |
|
|
|
| Primary | Gene Expression- Collagen 1 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change was calculated at each time point past baseline. Fold change = sample/average of the baseline. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Error | fold change | Day 7, Month 3 |
|
|
|
| Primary | Epidermal Density | Epidermal thickness will be masured via high resolution ultrasound prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment. The change from baseline was calculated at each time frame. | Posted | Mean | Standard Deviation | um | Baseline, Day 7, Week 3, Month 3 and Month 6 |
|
|
|
| Primary | Histological Analysis- Collagen 3 | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. Sample/Average of the baseline. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Deviation | fluorescence intensity | Baseline, Day 7, Month 3 |
|
|
|
| Primary | Histological Analysis- Elastin | Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame. Samples/Average of the baseline | Results at each visit show the change from baseline values. | Posted | Mean | Standard Deviation | fluorescence intensity | Baseline, Day 7, Month 3 |
|
|
|
| Primary | Gene Expression- Collagen 3 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Error | fold change | Day 7, Month 3 |
|
|
|
| Primary | Gene Expression- Elastin | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Error | fold change | Day 7, Month 3 |
|
|
|
| Primary | Gene Expression- Interluekin 6 | Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover. Fold change = sample/average of the baseline. | Results at each visit show the change from baseline values. | Posted | Mean | Standard Error | fold change | Day 7, Month 3 |
|
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|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
|
| Tingling Sensation | Skin and subcutaneous tissue disorders | Tingling Sensation | Systematic Assessment | Event reported on Day 7 |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | Lryngitis | Systematic Assessment | Event reported on Day 7 |
|
| Swelling on the knee | Skin and subcutaneous tissue disorders | Swelling | Systematic Assessment | Event reported on Day 7 |
|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment | Event reported at Day 7 |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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