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NCT Number: NCT04176068

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

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.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)

Combination Product

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 names: intense microfocused ultrasound

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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