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

Ulthera

Status: Completed

Conditions: Skin Laxity

Treatments: Drug: Lortab; Device: Ulthera System Treatment; Drug: Advil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708473

ULT-123

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Advil with Ultherapy

Active Comparator group

Description:

Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.

Treatment:

Drug: Advil

Device: Ulthera System Treatment

Lortab with Ultherapy

Active Comparator group

Description:

Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.

Treatment:

Device: Ulthera System Treatment

Drug: Lortab