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Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

NCT ID: NCT03545412

Last Updated: 2018-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-10

Study Completion Date

2014-08-20

Brief Summary

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To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

Detailed Description

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Conditions

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Facial Skin Laxity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microfocused ultrasound with visualization

Group Type EXPERIMENTAL

Microfocused ultrasound with visualization

Intervention Type DEVICE

Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Interventions

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Microfocused ultrasound with visualization

Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Intervention Type DEVICE

Other Intervention Names

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Ultherapy

Eligibility Criteria

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Inclusion Criteria

1. Willing to sign a written consent form
2. Willing to have of facial skin laxity and wrinkles assessed by clinician
3. Male or female, aged 39 to 65 years.
4. Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
5. Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
6. Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
7. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria

1. Open wounds or lesions in the area(s) to be treated.
2. Severe or cystic acne on the area(s) to be treated.
3. Presence of an active systemic or local skin disease that may affect wound healing.
4. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
5. Subcutaneous fillers
6. Keloid scar
7. Patients with anticoagulant treatment plan.
8. Children, pregnant women, breastfeeding women.
9. Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)
Minimum Eligible Age

39 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulthera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merz Medical Expert

Role: STUDY_DIRECTOR

Merz North America, Inc.

References

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Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017 Nov;43(11):1332-1338. doi: 10.1097/DSS.0000000000001181.

Reference Type RESULT
PMID: 28945618 (View on PubMed)

Other Identifiers

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ULT-215

Identifier Type: -

Identifier Source: org_study_id