Clinical trial NCT01713686: Evaluation of the Ulthera System for the Treatment of the Decolletage
Official title: Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Wrinkles
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Micro-focused Ultrasound with Visualization (MFU-V)
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 129
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Eligibility criteria: Inclusion Criteria:

* Female, aged 35 to 70 years.
* Subject in good health.
* Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.
* Absence of physical conditions unacceptable to the investigator.
* Willingness and ability to provide written consent for study-required photography.
* Willingness and ability to provide written informed consent.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertrophic scarring.
* Inability to understand the protocol or to give informed consent.
* Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
* Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
* History of chronic drug or alcohol abuse.
* History of autoimmune disease.
* Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
* Subjects who anticipate the need for surgery or overnight hospitalization during the study.
* Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
* Concurrent enrollment in any study involving the use of investigational devices or drugs.
* Current smoker or history of smoking in the last one year.
* History of using the following prescription medications:

  1. Topical Retinoids to the area within the past two weeks;
  2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
  3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Primary outcomes:
measure: Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
timeFrame: 90 Days post-treatment
measure: Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
timeFrame: 180 days post treatment
Secondary outcomes:
measure: Overall Aesthetic Improvement at 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Overall Aesthetic Improvement at 180 Days Post-treatment
timeFrame: 180 days post-treatment
measure: Subject Satisfaction at 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Subject Satisfaction at 180 Days Post-treatment
timeFrame: 180 days post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser Skin and Surgery Center of Northern California
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
state: California
city: Chicago
country: United States
facility: Denova Research
state: Illinois
city: Nashville
country: United States
facility: Tennessee Research Center
state: Tennessee
Study officials:
affiliation: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
name: Mitchel P Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: