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Completed

NCT Number: NCT01708473

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

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

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, 20852, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advil

Drug

One (1) tablet 800 mg Advil one hour prior to treatment.

Lortab

Drug

One (1) tablet 10/500 mg of Lortab one hour prior to treatment.

Ulthera System Treatment

Device

Focused ultrasound energy delivered below the surface of the skin

Other names: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Primary outcomes

  1. Treatment discomfort

    Time frame: During treatment

    The validated NRS scale will be used to measure average pain scores reported by subject during treatment.

Secondary outcomes

  1. Improvement in skin laxity

    Time frame: 90 days following treatment

    Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Feasibility Study: Comparison Of Advil® Vs. Lortab® For Reducing Discomfort Associated With Ultherapy™ Treatment

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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