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

Not Applicable

Completed

• Conditions: Skin Laxity
• Interventions: Drug: Advil; Drug: Lortab; Device: Ulthera System Treatment

• Registration Number: NCT01708473
• Lead Sponsor: Ulthera, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advil with Ultherapy	Advil	Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Advil with Ultherapy	Ulthera System Treatment	Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
Lortab with Ultherapy	Ulthera System Treatment	Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
Lortab with Ultherapy	Lortab	Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.

Primary Outcome Measures

Name	Time	Method
Treatment discomfort	During treatment	The validated NRS scale will be used to measure average pain scores reported by subject during treatment.

Secondary Outcome Measures

Name	Time	Method
Improvement in skin laxity	90 days following treatment	Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.

Trial Locations

Locations (1)

Dermatology, Cosmetic & Laser Surgery; 🇺🇸 Rockville, Maryland, United States