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NCT03507036 · ClinicalTrials.gov registry record · NA
Radio Frequency Microneedling for Suprapatellar Skin
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03507036: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT03507036 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03507036, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Profound system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2019-05-01 |
| Phase | NA |
What the finished NCT03507036 record still lists
NCT03507036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Profound system is the first listed.
NCT03507036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03507036 about?
NCT03507036 is a clinical study titled "Radio Frequency Microneedling for 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, m...
What is the current status of trial NCT03507036?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-03-15. Estimated completion is 2019-05-01.
What interventions are being tested in trial NCT03507036?
The interventions under investigation include: Profound system (DEVICE).
Who is sponsoring clinical trial NCT03507036?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03507036's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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