Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments
Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment
1 other identifier
interventional
20
1 country
1
Brief Summary
This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedNovember 24, 2017
June 1, 2013
7 months
October 15, 2012
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment discomfort
The validated NRS scale will be used to measure average pain scores reported by subject during treatment.
During treatment
Secondary Outcomes (1)
Improvement in skin laxity
90 days following treatment
Study Arms (2)
Advil with Ultherapy
ACTIVE COMPARATORSubjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Lortab with Ultherapy
ACTIVE COMPARATORSubjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
Interventions
Focused ultrasound energy delivered below the surface of the skin
Eligibility Criteria
You may qualify if:
- Male or female, aged 30 to 65 years
- 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
You may not qualify if:
- Known sensitivity to ibuprofen, acetaminophen, or opiates
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulthera, Inclead
Study Sites (1)
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, 20852, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hema Sundaram, MD
Dermatology, Cosmetic & Laser Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 17, 2012
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 24, 2017
Record last verified: 2013-06