# 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). --- # 🧪 울쎄라 (Ultherapy) – 한국형 케이스 비교표 |환자 프로필|주요 고민|피부/해부학 상태|울쎄라 적용 부위 & 카트리지|예상 결과 (3–6개월)|주의할 합병증| |---|---|---|---|---|---| |👩 43세 여성 (사무직)|팔자주름, 턱선 무너짐|중등도 피부 늘어짐, 지방층 얇음, SMAS 약간 이완|3.0mm (deep dermis) + 4.5mm (SMAS) → midface & jawline|팔자주름 완화, 턱선 또렷해짐, 전체적인 “동안 인상”|시술 직후 부종·홍반, 드물게 지방 위축| |👨 52세 남성 (중소기업 대표)|경부 늘어짐, 이중턱|피부 두꺼움, submental fat 다소 존재, SMAS 느슨|4.5mm (SMAS) + 3.0mm (deep dermis) → submental & neck|이중턱 개선, 목선 리프팅, 셔츠 입을 때 깔끔한 목선|통증 강도 ↑ (신경차단술 필요), 며칠간 압통| |👩 36세 여성 (육아맘)|눈가 잔주름, 눈꺼풀 처짐|피부 얇음, periorbital fine rhytids|1.5mm (superficial dermis) + 3.0mm (deep dermis) → periorbital zone|눈꺼풀 처짐 개선, 눈매 시원해짐, 잔주름 완화|홍반·부종 1–2일, 드물게 일시적 감각 이상| |👩 58세 여성 (주부)|얼굴 전반적 처짐, 볼살 축 처짐|피부 얇음, 심한 laxity, 지방 위축 동반|3.0mm + 4.5mm 전안면 적용, but 심한 laxity → 단독 효과 제한|약간의 탄력 회복, but 수술적 리프팅 고려 권고|효과 불충분으로 환자 만족도↓ 가능성| |👨 47세 남성 (회사원)|광대 주변 처짐, 팔자 깊어짐|피부 중등도 두께, midface fat descent|4.5mm (SMAS) 집중 → zygomatic & midface|광대 아래 볼살 리프팅, 팔자주름 개선|일시적 멍, 드물게 말초신경 자극감| --- ## ✅ 핵심 정리 1. **30–40대, 초기 늘어짐** → 울쎄라 단독으로도 충분한 리프팅 (눈가·턱선). 2. **50대, 지방 많고 피부 두꺼운 경우** → 울쎄라 단독 효과 있으나, 슈링크/온다 같은 장비와 병합 시 최적. 3. **고령 환자(55세 이상), 심한 처짐** → 울쎄라만으로 한계 → 수술적 옵션 고려 필요. ---