Skin Laxity
Conditions
Brief summary
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.
Detailed description
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
Interventions
DRUGL.M.X.4.® cream
A lidocaine topical anesthetic cream
OTHERA placebo cream
Placebo cream containing no anesthetic properties.
DEVICEUlthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sponsors
Ulthera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 30 to 65 years. * Chosen an Ultherapy™ treatment as part of their treatment regimen. * Subject in good health. * Skin laxity on the face and neck. * Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period. * Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion criteria
* Known sensitivity to lidocaine or any other anesthetic of the amide type. * History of anaphylactic shock. * Presence of an active systemic or local skin disease that may affect wound healing. * Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine). * Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3). * Severe solar elastosis. * Excessive subcutaneous fat in the face and neck. * Body mass index of 30 or greater. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related pain | During treatment | The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in skin laxity. | 90 days post-treatment | Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs. |
Countries
United States
Outcome results
None listed