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

Phase 1

Completed

• Conditions: Skin Laxity
• Interventions: Combination Product: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)

• Registration Number: NCT04176068
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician.
2. Subjects between the ages of 18-85 years old, at the time of consent.
3. Subjects may be male or female.
4. Subjects can be of any Fitzpatrick Skin type (I-VI).
5. Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand.

Exclusion Criteria

1. Children and adolescents (less than 18 years old).
2. Subjects who are not willing or able to provide written consent.
3. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
4. Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
5. Subjects with known blood coagulopathies.
6. Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease).
7. Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks.
8. Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks.
9. Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product.
10. Subjects with open wounds in the area of ultrasound treatment.
11. Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment.
12. Female patients who are planning a pregnancy, currently pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined microfocused ultrasound and calcium hydroxylapatite	calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of combined therapy at 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of combined therapy at 24 weeks	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	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	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).

Trial Locations

Locations (1)

University of California, Irvine Dermatology Clinical Research Center; 🇺🇸 Irvine, California, United States