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NCT04176068 · ClinicalTrials.gov registry record · Phase 1
Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration
A Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04176068: Completed Phase 1 study, sponsored by University of California, Irvine.
NCT04176068 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04176068, a Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. This study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera) and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.
Primary Outcome
To determine the efficacy of intense focused ultrasound (IFUS) + calcium hydroxylapatite (CaHA) filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Global Aesthetic Improvement Scale (scale 1-7 with 1 being much improved and 7 being much worse) at 12 weeks.
Interventions
- COMBINATION_PRODUCT calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-04-19 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 1 |
What the finished NCT04176068 record still lists
NCT04176068 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) is the first listed.
NCT04176068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176068 about?
NCT04176068 is a clinical study titled "Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration". Non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers have started combini...
What is the current status of trial NCT04176068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-04-19. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT04176068?
The interventions under investigation include: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04176068?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04176068's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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