Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
NCT ID: NCT01708473
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2011-07-31
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Advil with Ultherapy
Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Advil
One (1) tablet 800 mg Advil one hour prior to treatment.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Lortab with Ultherapy
Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
Lortab
One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Advil
One (1) tablet 800 mg Advil one hour prior to treatment.
Lortab
One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject in good health
* Skin laxity on the upper and lower face and neck
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
Exclusion Criteria
* Presence of an active systemic or local skin disease that may affect wound healing
* Severe solar elastosis
* Excessive subcutaneous fat in the face and neck
* Excessive skin laxity on the face and neck
* Significant scarring in areas to be treated
* Significant open facial wounds or lesions
* Severe or cystic acne on the face
* Presence of a metal stent or implant in the facial area to be treated
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ulthera, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hema Sundaram, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology, Cosmetic & Laser Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ULT-123
Identifier Type: -
Identifier Source: org_study_id