Clinical trial NCT04176068: Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration
Official title: Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Laxity
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of combined therapy at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy of combined therapy at 24 weeks
timeFrame: 24 weeks
measure: Efficacy with Merz Aesthetic scale at 12 and 24 weeks
timeFrame: 24 weeks
measure: Patient satisfaction at 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine Dermatology Clinical Research Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Natasha Mesinkovska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: