Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration
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|ClinicalTrials.gov Identifier: NCT04176068|
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skin Laxity||Combination Product: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity|
|Actual Study Start Date :||April 19, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: Combined microfocused ultrasound and calcium hydroxylapatite
One-time intense microfocused ultrasound with calcium hydroxylapatite injection to one anterior lower thigh with option for additional filler injection at 6 weeks, 12 weeks, and 24 weeks. Optional combined treatment of the opposite lower anterior thigh at week 24 with no further follow up.
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.
Other Name: intense microfocused ultrasound
- Efficacy of combined therapy at 12 weeks [ Time Frame: 12 weeks ]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.
- Efficacy of combined therapy at 24 weeks [ Time Frame: 24 weeks ]To determine the efficacy of IFUS and 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 24 weeks.
- Efficacy with Merz Aesthetic scale at 12 and 24 weeks [ Time Frame: 24 weeks ]To determine the efficacy of IFUS and CaHA filler for the correction of skin laxity of the lower thigh as assessed by a blinded and an unblinded physician Merz Aesthetic Scale (Grade 0-4 with 0 being no skin laxity and 4 being very severe skin laxity) at 12 and 24 weeks.
- Patient satisfaction at 24 weeks [ Time Frame: 24 weeks ]To determine patient satisfaction 24 weeks post-treatment of IFUS + CaHA for the treatment of skin laxity of the lower thigh as assessed on a scale of 0-10 (with 0 being not satisfied and 10 being very satisfied).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176068
|Contact: Katerina Yale, MDemail@example.com|
|United States, California|
|University of California, Irvine Dermatology Clinical Research Center||Recruiting|
|Irvine, California, United States, 92697|
|Contact: Katerina Yale, MD 949-824-7103 firstname.lastname@example.org|
|Principal Investigator:||Natasha Mesinkovska, MD, PhD||University of California, Irvine|