- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507036
Radio Frequency Microneedling for Suprapatellar Skin
Pilot Study: Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Wrinkles of the Suprapatellar Skin
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male and female adults between ages 18-75 years of age.
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements
- Fitzpatrick skin type I-III
Exclusion Criteria:
- Subjects with active localized or systemic infections.
- Immunocompromised subjects.
- Subjects with coagulation disorder.
- History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- Subjects with a history of radiation therapy to the treatment area.
- Subject has a history of allergy to lidocaine or ester-based local anesthetics.
- Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
- Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photographic Knee Laxity and Texture Evaluation
Time Frame: baseline and 6 months
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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.
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baseline and 6 months
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Epidermal Thickness
Time Frame: baseline, 7 Days, 3 Weeks, 3 Months and 6 Months
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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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baseline, 7 Days, 3 Weeks, 3 Months and 6 Months
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Dermal Thickness
Time Frame: Baseline, 7 Days, 3 Weeks, 3 Months and 6 Months
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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.
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Baseline, 7 Days, 3 Weeks, 3 Months and 6 Months
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Change in Blood Flow at 0.25mm
Time Frame: Baseline, Day 7, Week 3 Month 3 and Month 6
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Blood Flow will be measured via optical coherence tomography prior to treatment (baseline), 7 days, 3 weeks, 3 months and 6 months post treatment.
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Baseline, Day 7, Week 3 Month 3 and Month 6
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Transepidermal Water Loss
Time Frame: Baseline, Day 7, Week 3, Month 3 and Month 6
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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.
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Baseline, Day 7, Week 3, Month 3 and Month 6
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Skin Elasticity
Time Frame: Baseline, Day 7, Week 3, Months 3 and Months 6
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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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Baseline, Day 7, Week 3, Months 3 and Months 6
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Change in Skin Laxity
Time Frame: baseline, 7 days, 3 weeks, 3 months and 6 months
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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.
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baseline, 7 days, 3 weeks, 3 months and 6 months
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Histological Analysis- Collagen 1
Time Frame: Baseline. Day 7 and 3 Months
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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.
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Baseline. Day 7 and 3 Months
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Gene Expression- Collagen 1
Time Frame: Day 7, Month 3
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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
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Epidermal Density
Time Frame: Baseline, Day 7, Week 3, Month 3 and Month 6
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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.
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Baseline, Day 7, Week 3, Month 3 and Month 6
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Histological Analysis- Collagen 3
Time Frame: Baseline, Day 7, Month 3
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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.
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Baseline, Day 7, Month 3
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Histological Analysis- Elastin
Time Frame: Baseline, Day 7, Month 3
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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
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Baseline, Day 7, Month 3
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Gene Expression- Collagen 3
Time Frame: Day 7, Month 3
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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
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Gene Expression- Elastin
Time Frame: Day 7, Month 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- Interluekin 6
Time Frame: Day 7, Month 3
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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
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 082017-079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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