Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708473
First received: October 15, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This study will compare the effectiveness of two pain medications for reducing discomfort during an Ultherapy treatment.


Condition Intervention
Skin Laxity
Drug: Advil
Drug: Lortab
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Treatment discomfort [ Time Frame: During treatment ] [ Designated as safety issue: No ]
    The validated NRS scale will be used to measure average pain scores reported by subject during treatment.


Secondary Outcome Measures:
  • Improvement in skin laxity [ Time Frame: 90 days following treatment ] [ Designated as safety issue: No ]
    Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advil with Ultherapy
Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Drug: Advil
One (1) tablet 800 mg Advil one hour prior to treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
Active Comparator: Lortab with Ultherapy
Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
Drug: Lortab
One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening

Detailed Description:

This trial is a prospective, single-site, double-blinded, randomized trial. All study subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized to receive one of two pain medications prior to treatment. Each subject will be asked to rate the level of discomfort during the Ultherapy treatment. All study subjects will be followed for 90 days following treatment.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708473

Locations
United States, Maryland
Dermatology, Cosmetic & Laser Surgery
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Hema Sundaram, MD Dermatology, Cosmetic & Laser Surgery
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708473     History of Changes
Other Study ID Numbers: ULT-123
Study First Received: October 15, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Ibuprofen
Acetaminophen, hydrocodone drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 28, 2014