Evaluation of the Ulthera System for the Treatment of the Decolletage

NCT01713686 | Completed Results DMC

• 1 other identifier: ULT-129
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 4

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.

Conditions

Chest Wrinkles

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Micro-focused Ultrasound with Visualization (MFU-V)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment

  Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

  90 Days post-treatment

• Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment

  Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

  180 days post treatment

Secondary Outcomes (4)

• Overall Aesthetic Improvement at 90 Days Post-treatment

  90 days post-treatment

• Overall Aesthetic Improvement at 180 Days Post-treatment

  180 days post-treatment

• Subject Satisfaction at 90 Days Post-treatment

  90 days post-treatment

• Subject Satisfaction at 180 Days Post-treatment

  180 days post-treatment

Study Arms (1)

Ulthera System Treatment

EXPERIMENTAL

A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Ulthera System Treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (4)

Laser Skin and Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, 92121, United States

Location

Denova Research

Chicago, Illinois, 60611, United States

Location

Tennessee Research Center

Nashville, Tennessee, 37215, United States

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Mitchel P Goldman, MD

  Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 11, 2017
• Results First Posted: March 9, 2015

Record last verified: 2017-11

Locations

US (4)