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

Primary Purpose

Skin Laxity

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Irvine Dermatology Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined microfocused ultrasound and calcium hydroxylapatite

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of combined therapy at 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

Efficacy of combined therapy at 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
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
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).

Full Information

First Posted
November 20, 2019
Last Updated
June 3, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT04176068
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined microfocused ultrasound and calcium hydroxylapatite
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
Other Intervention Name(s)
intense microfocused ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of combined therapy at 12 weeks
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy of combined therapy at 24 weeks
Description
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.
Time Frame
24 weeks
Title
Efficacy with Merz Aesthetic scale at 12 and 24 weeks
Description
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.
Time Frame
24 weeks
Title
Patient satisfaction at 24 weeks
Description
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).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician. Subjects between the ages of 18-85 years old, at the time of consent. Subjects may be male or female. Subjects can be of any Fitzpatrick Skin type (I-VI). 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: Children and adolescents (less than 18 years old). Subjects who are not willing or able to provide written consent. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician. 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). Subjects with known blood coagulopathies. 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). Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks. Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks. Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product. Subjects with open wounds in the area of ultrasound treatment. Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment. Female patients who are planning a pregnancy, currently pregnant or nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Mesinkovska, MD, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Dermatology Clinical Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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