# Chapter 4.2 Ultherapy: Mechanism & Evidence --- ## 1. Introduction - **Ultherapy** is the **first FDA-approved High-Intensity Focused Ultrasound (HIFU) device** for non-invasive lifting. - Developed by **Ulthera, Inc. (USA)**, now owned by **Merz Aesthetics**. - FDA clearances: - **2009** – Non-invasive eyebrow lift - **2012** – Lifting submental area and neck - **2014** – Improvement of décolletage lines/wrinkles - Distinguishing feature: **real-time ultrasound imaging** for accurate targeting of treatment depth. --- ## 2. Mechanism of Ultherapy ### (1) **Energy Delivery** - Emits **focused ultrasound waves** that converge at predetermined depths (1.5 mm, 3.0 mm, 4.5 mm). - Focal zone: ~1 mm³ (very precise). - Temperature at focal point: **60–70°C** → instantaneous protein denaturation. - Creates **thermal coagulation points (TCPs)** while sparing overlying epidermis. ### (2) **Layer-Specific Targeting** - **1.5 mm cartridge** → superficial dermis (fine wrinkles, texture). - **3.0 mm cartridge** → deep dermis (collagen remodeling). - **4.5 mm cartridge** → **SMAS layer**, same plane addressed in surgical facelifts. ### (3) **Biological Response** 1. **Immediate contraction** of collagen fibrils. 2. **Fibroblast stimulation** → new collagen and elastin synthesis. 3. **Tissue remodeling** → gradual lifting effect, peak at 3–6 months. 4. **Longevity**: Results last ~12–18 months, sometimes up to 2 years. --- ## 3. Clinical Evidence ### (1) **Brow Lift** - FDA pivotal trial (Ulthera, 2009): - Mean **1.7 mm elevation of brow height** at 90 days post-treatment. - 89% of patients showed measurable lift. ### (2) **Submental and Neck Lift** - FDA study (2012): - Significant reduction in submental skin laxity. - Blinded physician assessments: 66–78% improvement at 90 days. - Patient satisfaction ~70%. ### (3) **Décolletage Wrinkles** - FDA clearance (2014): - Single Ultherapy session improved **chest lines/wrinkles** for up to 6 months. ### (4) **Independent Clinical Studies** - **Fabi et al., Dermatol Surg 2015**: - 93% of patients improved in lower face/jawline laxity. - **Alster & Tanzi, Lasers Surg Med 2012**: - Sustained tightening effects at 12 months. - **Korea/Japan studies**: - High patient satisfaction (80–90%) for jawline and periorbital tightening. --- ## 4. Treatment Protocols - **Patient selection**: best for **30–55 years old** with mild-to-moderate laxity. - **Procedure**: - Skin cleansing → ultrasound gel → real-time ultrasound mapping. - Cartridges applied in linear “lines” across treatment zones. - Typical face/neck session: 400–800 lines. - **Pain management**: - Topical anesthetics, oral analgesics (NSAIDs, tramadol). - Regional nerve blocks for sensitive patients. - **Session duration**: 30–90 minutes. - **Downtime**: minimal; mild redness/swelling only. --- ## 5. Clinical Outcomes - **Efficacy**: - Visible tightening of brow, jawline, submental, and neck. - Improvement in fine lines and wrinkles. - **Onset**: subtle immediate tightening; full results at 3–6 months. - **Longevity**: typically 12–18 months; repeat annually for maintenance. - **Combination therapy**: - Ultherapy + Thermage (dermal + SMAS) = layered tightening. - Ultherapy + fillers/threads = lifting + volumizing. --- ## 6. Safety Profile - **Common transient effects**: erythema, edema, tingling, tenderness (resolve within days). - **Less common**: temporary numbness, bruising, welts. - **Rare**: - Fat atrophy (if too much energy in superficial fat). - Neuropathic pain/nerve injury (<1%). - **Overall**: very safe, minimal downtime, high safety margin compared to lasers. --- ## 7. Key Clinical Insights - Ultherapy remains the **gold standard HIFU device**, with the most robust clinical data and FDA indications. - Particularly effective for **brow lift, jawline contouring, submental tightening**. - Pain control and patient expectation management are critical for satisfaction. - Best results are achieved when combined with **other modalities** (RF, injectables, regenerative therapies). ---