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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 19, 2019

Primary Completion Date

December 1, 2021

Study Completion Date

December 1, 2021

Conditions
Skin Laxity
Interventions
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.

Trial Locations (1)

92697

University of California, Irvine Dermatology Clinical Research Center, Irvine

All Listed Sponsors
lead

University of California, Irvine

OTHER

NCT04176068 - Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration | Biotech Hunter | Biotech Hunter