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Radio Frequency Microneedling for Suprapatellar Skin

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ClinicalTrials.gov Identifier: NCT03507036
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey M. Kenkel, University of Texas Southwestern Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Skin Laxity Device: Profound system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Clinical Assessment of Bipolar Radiofrequency Microneedling for Improved Laxity and Wrinkles of the Suprapatellar Skin
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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.

Device: Profound system
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.




Primary Outcome Measures :
  1. Photographic Evaluation [ Time Frame: 6 months ]
    Photographs will be used to evaluate efficacy of treatment

  2. Epidermal Thickness [ Time Frame: 6 months ]
    High resolution ultrasound will be used to assess epidermal thickness

  3. Dermal Thickness [ Time Frame: 6 months ]
    High resolution ultrasound will be used to measure dermal thickness pre-treatment and post treatment.

  4. Epidermal Density [ Time Frame: 6 months ]
    High resolution ultrasound will be used to assess epidermal density prior to treatment and post-treatment.

  5. Blood flow [ Time Frame: 6 months ]
    Optical coherence tomography will be used to assess amount of blood flow through the area, pre-treatment and post treatment.

  6. Transepidermal water loss [ Time Frame: 6 months ]
    Aquaflux will be used to assess transepidermal water loss prior to treatment and post treatment. The Aquaflux device is an non-invasive skin measuring tool, that measures the amount of water leaving the subject's skin over a period of time.

  7. Skin Elasticity [ Time Frame: 6 months ]
    BTC2000 will be used to measure skin elasticity prior to treatment and post treatment. The BTC2000 is a non-invasive device that measures elasticity by creating a negative pressure against the skin and measure elasticity when the pressure is released.

  8. Skin Laxity [ Time Frame: 6 months ]
    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.

  9. Histological analysis [ Time Frame: 6 months ]
    Biopsies of the treated area will be taken prior to treatment and post treatment of histological analysis for collagen and neocollagenesis.

  10. Gene expression analysis [ Time Frame: 6 months ]
    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.

  11. Epidermal Thickness [ Time Frame: 6 months ]
    Optical coherence tomography will be used to assess epidermal thickness pre and post treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507036


Contacts
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Debby Noble       debby.noble@utsouthwestern.edu   
Principal Investigator: Jeffrey Kenkel, MD         
Sub-Investigator: Nicholas Lahar, MD         
Sub-Investigator: John Hoopman         
Sub-Investigator: Yucel Akgul, MD. PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jeffrey Kenkekel, MD Chair & Professor

Publications:
Responsible Party: Jeffrey M. Kenkel, Betty and Warren Woodward Chair in Plastic and Reconstructive Surgery, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03507036     History of Changes
Other Study ID Numbers: STU 082017-079
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jeffrey M. Kenkel, University of Texas Southwestern Medical Center:
knee area
suprapatellar skin
aging
laxity

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases