Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176068
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Skin Laxity Combination Product: calcium hydroxylapatite (Radiesse) and IFUS (Ulthera) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Ultrasound

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Katerina Yale, MD 949-824-7103 dermresearch@uci.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Dermatology Clinical Research Center Recruiting
Irvine, California, United States, 92697
Contact: Katerina Yale, MD    949-824-7103    dermresearch@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Natasha Mesinkovska, MD, PhD University of California, Irvine
Layout table for additonal information
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04176068    
Other Study ID Numbers: 2018-4856
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs