Radio Frequency Microneedling for Suprapatellar Skin
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/1/2019 |
| Start Date: | March 15, 2018 |
| End Date: | December 1, 2019 |
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.
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.
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.
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.
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Jeffrey Kenkel, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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