NCT04176068

Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration

Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)	Patients will receive IFUS to a randomly chosen side. Immediately after IFUS treatment, patients will receive the first CaHA injection. Injections will be given in the lower, anterior third of the thigh, above the knee. Only dermatology faculty will perform the filler injections. The patients will be instructed to return to the office in 6 weeks, 12 weeks, and 24 weeks (+/- 5 business days) for their next appointment for follow-up and injection of CaHA if deemed necessary by the investigator. At all visits (Visits 1-4) patients will have photographs and unblinded physician/patient questionnaires will be completed. At Visit 4 (24 weeks +/- 5 business days), patients will be given the option to receive treatment for skin laxity to the previously untreated side. If the patient chooses to receive treatment, patients will receive their second IFUS and CaHA combination treatment at this time. They will not receive further treatment after this visit.

Timeline

• Start date: 2019-04-19
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-11-25
• Last updated: 2024-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study