N/A
N=125
Evaluation of the Ulthera System for the Treatment of the Decolletage
Chest Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01713686 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment — 69.9; 15.9; 14.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera System Treatment (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Ulthera, Inc
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment |
69.9; 15.9; 14.2 | — |
| PRIMARY Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment |
66.4; 11.2; 22.4 | — |
| SECONDARY Overall Aesthetic Improvement at 90 Days Post-treatment |
75.1; 24.1; 0.9 | — |
| SECONDARY Overall Aesthetic Improvement at 180 Days Post-treatment |
66.4; 30.0; 3.6 | — |
| SECONDARY Subject Satisfaction at 90 Days Post-treatment |
65.5; 29.3; 5.2 | — |
| SECONDARY Subject Satisfaction at 180 Days Post-treatment |
62.7; 22.7; 14.5 | — |
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:
- Topical Retinoids to the area within the past two weeks;
- Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
- Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Data sourced from ClinicalTrials.gov (NCT01713686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.