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

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708473
• Other study ID #: ULT-123
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Drug:
• 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.

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	Dermatology, Cosmetic & Laser Surgery	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment discomfort	The validated NRS scale will be used to measure average pain scores reported by subject during treatment.	During treatment
Secondary	Improvement in skin laxity	Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.	90 days following treatment