Early Experience With Ultherapy Prime in Asia Pacific: A Pilot Case Series

Abstract

Background:

Microfocused ultrasound with real-time visualization is well established as a safe and effective treatment for noninvasive skin lifting. Ultherapy Prime is an updated treatment with an advanced processor and improved imaging capabilities that uses microfocused ultrasound with real-time visualization technology to stimulate tissue remodeling and tightening to improve skin laxity. As published data on Ultherapy Prime in Asian patients are lacking, we conducted a case series to describe the effectiveness and safety of Ultherapy Prime for noninvasive skin lifting and improvement of skin laxity in Asians.

Methods:

Thirty participants with mild-to-severe sagging on the Merz Aesthetics Scale (MAS) for jawline and neck volume received Ultherapy Prime treatment. Dual-depth treatment with 650 lines or more of microfocused ultrasound was customized to the patients’ facial anatomies using the See, Plan, Treat approach and applied to the fibrous and deep dermal layers. Outcomes assessed included the MAS for jawline and neck volume, subject and physician Global Aesthetic Improvement Scale scores, and pain scores.

Results:

Most participants achieved 1 point or greater improvement in neck volume and jawline using the MAS at day 90, regardless of Fitzpatrick phototypes, age, body mass index, or sex. Global Aesthetic Improvement Scale improvement was reported for all physicians and patients (100%), with ratings varying from improved to very improved and very much improved. Treatment was well tolerated (mean pain score 4.50).

Conclusions:

A single Ultherapy Prime treatment is associated with clinical improvements in jawline and neck skin laxity and is well tolerated in Asian patients across demographics.

Takeaways

Question: Can Ultherapy Prime effectively and safely improve skin laxity in Asians?

Findings: Ultherapy Prime produced significant clinical improvements in neck volume and jawline sagging after a single treatment. Among Asian patients (n = 30), 86.7% and 70% achieved at least a 1 point improvement on the Merz Aesthetic Scales at 90 days, respectively. Treatment was well tolerated (mean pain score 4.50), and all patients reported satisfaction. Efficacy was consistent across age, body mass index, and sex.

Meaning: Ultherapy Prime appears to be a safe and effective noninvasive treatment for improving skin laxity in Asian patients, offering visible aesthetic improvements regardless of individual characteristics.

INTRODUCTION

The cosmetic medicine landscape in the Asia Pacific region is poised for transformation, with noninvasive procedures¹ and energy-based devices (EBDs) projected to generate revenues exceeding US $7.5 billion in the region by 2027.^2,3 This shift aligns with Asian patients’ preferences for safe, noninvasive treatments with minimal downtime,^4–7 prompting physicians to seek aesthetic technologies that meet these demands.

EBDs deliver thermal energy to skin tissues, stimulating collagen production and remodeling to improve pore size, skin elasticity, wrinkle depth, and skin lifting and tightening.^7–10 Among the many EBDs used in aesthetic practice, including radiofrequency and high-intensity focused ultrasound, microfocused ultrasound with real-time visualization (MFU-V; Ultherapy or Ulthera System; Merz Aesthetics [Ulthera, Inc.], Raleigh, NC) is the only EBD with real-time ultrasound visualization up to a depth of 8 mm. Ultherapy is widely used for noninvasive skin lifting¹¹ due to several factors. Its DeepSEE technology¹² provides real-time visualization of tissue layers, allowing physicians to customize treatment plans to each patient’s unique anatomy and precisely deliver microfocused ultrasound (MFU) energy to collagen-rich fibrous (superficial musculoaponeurotic system and platysma) and deep dermal layers while avoiding nontarget tissues.¹³ When MFU energy is deposited at specific areas in target tissue layers, consistent and uniform thermal coagulation points are created to stimulate neocollagenesis and elastogenesis.^14–16 Subsequent tissue remodeling and tightening gradually lifts the skin,^13,17,18 producing results that are noticeable after a few weeks and last for at least 1 year.^19,20 The unique Food and Drug Administration–cleared real-time ultrasound visualization capability of MFU-V also enhances safety by facilitating good transducer-to-skin coupling and enabling physicians to avoid structures such as bone and blood vessels.^11,12 Its high-performing transducer acoustics excel in focal gain, operating frequencies, and beam dimension, enabling physicians to create distinct, evenly sized thermal coagulation points at 3 specific depths of 1.5, 3.0, and 4.5 mm below the surface of the skin,^13,21 avoiding the epidermis^7,10 and initiating an intrinsic wound healing response via adjacent untreated tissues.^{12–15,22,23} Moreover, MFU-V safely treats different skin tones by using energy that bypasses melanin absorption²⁴ and can effectively lift mild-to-moderate lax skin in Fitzpatrick phototypes III–VI.²⁵ Multiple publications and clinical studies^{12,13,20,26–30} have now evaluated the effectiveness and safety of MFU-V across diverse patient demographics and treatment areas.¹¹

Ultherapy Prime is a next-generation MFU-V system that is US Food and Drug Administration–cleared for nonsurgical lifting of the brow, submental area, and neck and improving the appearance of décolleté wrinkles.³¹ Built on the efficacy, safety, and patient satisfaction of MFU-V technology of the first-generation Ultherapy device,^11,32 Ultherapy Prime incorporates an advanced processor that allows smoother and faster ultrasound image transitions, and clearer multiangle viewing for physicians to perform more precise and quicker treatments.^32–35 Coupled with the See, Plan, Treat protocol, which provides a structured framework to guide physicians in maximizing Ultherapy Prime’s real-time visualization capabilities for treatment planning and delivery, the updated device is expected to facilitate targeted aesthetic treatment outcomes with improved patient comfort and lower risks of adverse events.^13,36,37 The updated user interface and enhanced procedural efficiency of Ultherapy Prime aim to improve the clinical usage of MFU-V–based noninvasive skin lifting and rejuvenation for both patients and physicians. We present the first case series of Ultherapy Prime treatment in an all-Asian population to provide preliminary clinical findings on its safety and efficacy for noninvasive skin lifting, offering practical insights supporting the performance of Ultherapy Prime.

METHODS

Overview

From July 2024 to October 2024, 3 clinics across Singapore enrolled 30 participants, with at least 8 participants from each clinic. These treatments were performed by 3 physicians, each with more than 10 years of expertise in performing MFU-V treatments. This case series involved standard of care treatments with MFU-V and was performed in accordance with the general principles of the Declaration of Helsinki.

Participants

Male and female participants aged 35–65 years with mild-to-severe sagging (grade 1–3) on the Merz Aesthetics Scale (MAS)^38,39 for neck volume and jawline were included in this case series. All participants abstained from surgical and nonsurgical cosmetic treatments to the face and upper neck for 90 days post treatment with MFU-V. Exclusion criteria included scarring; significant ptotic skin or subcutaneous fat; any condition that might alter wound healing; recent skin procedures in the treatment area, including skin tightening; recent ablative or nonablative skin procedures; any injectable filler, liposuction, or fat grafting in the face and neck within the past 12 months; and neurotoxins in the lower face or neck within the past 6 months. (See table, Supplemental Digital Content 1, which displays the full inclusion and exclusion criteria, https://links.lww.com/PRSGO/E464.)

All participants provided informed consent for treatment using the Ultherapy Prime system and permission to publish their photographs and case details. Patients seeking noninvasive skin lifting were given the option to receive the treatment free of charge.

Pretreatment Planning

All accessories and cosmetics were removed from the treatment area, which was then cleansed. A personalized treatment regimen was formulated based on the See, Plan, Treat approach^12,34 using the Ultherapy Prime system’s ultrasound visualization to identify and record specific depths of the target fibrous and deep dermal tissue layers in each facial region. The standard comfort management guidance was topical anesthetic cream applied for at least 30 minutes before treatment. Physicians provided additional oral analgesics if needed or depending on their routine clinical practice, participants’ requests, or participants’ medical history, which mirrored real-world practice.

See, Plan, Treat Protocol

Ultherapy’s transducers facilitate tissue visualization up to 8 mm below the skin surface, enabling doctors to “see, plan, and treat”³⁴ with precision when determining where to deliver MFU energy. They allowed dual-depth treatment to be tailored to the specific depths of the superficial musculoaponeurotic system and platysma, and deep dermis in each participant’s lower face and neck. Real-time visualization also enables physicians to verify proper transducer coupling and adjust the application pressure. Each participant received at least 650 lines of MFU at a preset energy level of 2. Participants were advised to avoid vigorous exercises for 3-5 days after treatment and were scheduled for a follow-up visit on day 90 (D90).

Outcomes

High-quality pretreatment 3-dimensional photographs capturing 4 facial angles were taken using the QuantifiCare Photography System (QuantifiCare Inc., Suwanee, GA) at baseline and D90. Treatment outcomes at D90 were assessed using the MAS for neck volume and jawline, as well as physician and patient Global Aesthetic Improvement Scale (GAIS).⁴⁰ The 5-point GAIS was used by physicians and patients to rate improvements: 5—very much improved, 4—much improved, 3—improved, 2—no change, and 1—worse. The 5-point MAS for neck volume³⁸ and jawline³⁹ was used by physicians to rate improvements: 0—no sagging, 1—mild sagging, 2—moderate sagging, 3—severe sagging, and 4—very severe sagging. Pain scores were also assessed immediately after treatment using a validated 11-point (0–10) numeric rating scale (NRS), where 0 denoted no pain and 10 denoted the worst possible pain.

Statistical Analysis

All analyses were performed using R (version 4.4.1) with 2-sided tests at 5% significance. Continuous variables were summarized using mean (±SD) and median (minimum–maximum range) values, and categorical variables were summarized by counts and proportions. Ninety-five percent confidence intervals (CIs) were derived using the Clopper–Pearson interval for responder rates and bootstrapped methods for pain scores. The Wilcoxon signed-rank test was used to assess the statistical significance of the changes between baseline and D90 for the MAS for neck volume and jawline. Subgroup analyses were performed by stratifying responder rates according to age, body mass index (BMI⁴¹), and sex and using χ² tests to evaluate statistically significant differences. Exploratory correlations between BMI and units of improvement in MAS for neck volume and jawline were assessed using Spearman correlation. All P values were adjusted using the Benjamini–Hochberg method for multiple comparisons. The meta package was used to derive a pooled estimate of mean overall pain scores from previous studies^42,43 using similar treatment protocols and treatment areas with the first-generation device.

RESULTS

The 30 enrolled participants (Table 1) had a mean age of 45.5 years (SD ±7.18), with most being woman (83.3%) and ethnically Chinese (93.3%), with a mean weight of 64.3 kg (SD ±11.3 kg) and a mean BMI of 24.3 kg/m² (SD ±3.61 kg/m²). The majority (60.0%) of the participants had a BMI less than 25 kg/m² (Table 1). At day 0 (D0), 70% of participants had mild jawline sagging, 26.7% had moderate sagging, and 3.3% had severe sagging. Neck volume sagging was mild in 60.0% of participants, moderate in 36.7%, and severe in 3.3%. Fitzpatrick phototype III occurred most frequently (43.3%), followed by types IV (40.0%), V (10.0%), and II (6.7%). The mean number of treatment lines delivered was 792.3 (SD ±61.1), with a mean treatment duration of 45.6 (SD ±5.4) minutes (data not shown).

Table 1.

Patient Demographics and Characteristics

Patient Demographics and Characteristics	Patients (N = 30)
Age, y
Mean (SD)	45.5 (7.18)
Median [min, max]	43.5 [36.0, 62.0]
≥35 and <45, n (%)	18 (60.0)
≥45 and <55, n (%)	7 (23.3)
≥55 and <65, n (%)	5 (16.7)
Sex, n (%)
Female	25 (83.3)
Male	5 (16.7)
Race, n (%)
Chinese	28 (93.3)
Filipino	1 (3.3)
Malay	1 (3.3)
Weight, kg
Mean (SD)	64.3 (11.3)
Median [min, max]	64.5 [47.0, 94.0]
BMI, kg/m2*
Mean (SD)	24.3 (3.61)
Median [min, max]	23.6 [18.8, 32.5]
<25, n (%)	18 (60.0%)
≥25, n (%)	12 (40.0)
MAS for jawline (scale: 0—no sagging, 1—mild sagging, 2—moderate sagging, 3—severe sagging, 4—very severe sagging), n (%)
0	0 (0.0)
1	21 (70.0)
2	8 (26.7)
3	1 (3.3)
4	0 (0.0)
MAS for neck volume (scale: 0—no sagging, 1—mild sagging, 2—moderate sagging, 3—severe sagging, 4—very severe sagging), n (%)
0	0 (0.0)
1	18 (60.0)
2	11 (36.7)
3	1 (3.3)
4	0 (0.0)
Fitzpatrick phototype, n (%)
I	0 (0.0)
II	2 (6.7)
III	13 (43.3)
IV	12 (40.0)
V	3 (10.0)
VI	0 (0.0)

^*BMI range in Asians—underweight: <18.5 kg/m², normal: 18.5–22.9 kg/m², overweight: 23–27.49 kg/m², and obese: >27.5 kg/m².

max, maximum; min, minimum.

At D90, MAS assessments showed that 86.7% (95% CI, 69.3–96.2) (Table 2) of participants had a 1 point or greater improvement in neck volume sagging, and 70.0% (95% CI, 50.6–85.3) had a 1 point or greater improvement in jawline sagging. Moreover, from D0 to D90 (Fig. 1), Ultherapy Prime treatment improved neck volume sagging as the proportion of participants with severe sagging decreased from 3.3% to 0%, those with moderate sagging decreased from 36.7% to 3.3%, and those with mild sagging decreased from 60.0% to 36.7%; however, the proportion of patients without neck volume sagging increased from 0% to 60.0%. Similarly, between D0 and D90, the proportion of participants without jawline sagging (Fig. 1) increased from 0% to 53.3%, those with mild sagging decreased from 70.0% to 43.3%, those with moderate sagging decreased from 26.7% to 6.7%, and those with severe sagging decreased from 3.3% to 0%. In both areas, improvements in sagging were significant (P = 0.0000156 and P = 0.0000957, respectively). When stratified by severity at baseline (Fig. 2), all participants graded as moderate or severe on the MAS for both neck volume and jawline showed improvements at D90, with 33.3% improving by 2 points and 66.7% improving by 1 point on the MAS for neck volume, whereas 44.4% improved by 2 points and 55.6% improved by 1 point on the MAS for jawline. GAIS evaluations by physicians and patients corroborated with reductions in MAS scores, with all participants rated as at least improved at D90. (See table, Supplemental Digital Content 2, which displays the Ultherapy Prime results, https://links.lww.com/PRSGO/E465.) The GAIS was rated as improved by 36.7% of physicians and 40.0% of participants, very improved by 43.3% of physicians and 26.7% of participants, and very much improved by 20.0% of physicians and 33.3% of participants. Pre- and posttreatment photographs of 2 representative patients are presented in Supplemental Digital Content 3. (See figure, Supplemental Digital Content 3, which displays the overall aesthetic improvements. The GAIS was assessed at the physician and patient levels, https://links.lww.com/PRSGO/E466.)

Table 2.

Participants Experiencing Any Improvements (Responders) in Merz Aesthetics Scale for Neck Volume and Jawline at 90 Days After Treatment

	No. Responders (Improved ≥1 Point)		Change in Score
	N (%)	95% CI	Median (IQR)	Mean (SD)
Neck volume	26 (86.7)	69.3–96.2	−1.00 (1.00)	−1.00 (0.53)
Jawline	21 (70.0)	50.6–85.3	−1.00 (0)	−0.83 (0.65)

IQR, interquartile range.

Fig. 1.

Improvement in neck volume (A) and jawline (B). Improvements were assessed using the Merz Aesthetic Scale for the treated areas.

Fig. 2.

Level of improvement in neck volume (A) and jawline (B) after Ultherapy Prime treatment. Neck volume or jawline stratified by baseline severity.

Subgroup analyses of responder rates (≥1 point improvement) for the MAS for neck volume and jawline are presented in Table 3. With respect to neck volume, responder rates were highly similar after stratification by sex, BMI, and age. Slight variations were observed in responder rates for jawline among sex (man versus woman), BMI (<25 versus ≥25 kg/m²), and age (35–44 versus 45–54 versus 55–64 years). These differences were not significant for sex (P = 0.407) or for age (P = 0.407). For BMI, the difference was borderline significant (P = 0.061). In further correlation analyses, no statistically significant correlations were detected between BMI and improvements in MAS score for neck volume (rho = 0.108, P = 0.712) and MAS for jawline (rho = 0.260, P = 0.332). All 30 participants (100%) reported overall satisfaction with their Ultherapy Prime treatment, and 29 of the 30 (96.7%) participants recommended Ultherapy Prime treatment to others.

Table 3.

Subgroup Analyses of Responses According to Sex, Body Mass Index, and Age

Demographic Characteristic	N	Merz Aesthetic Scale for Neck Volume		Merz Aesthetic Scale for Jawline
		Responder, N (%)	Adjusted P*	Responder, N (%)	Adjusted P*
Sex
Female	25	21 (84)	0.900	16 (64)	0.407
Male	5	5 (100)		5 (100)
BMI, kg/m2
<25	18	16 (88.9)	1.00	16 (88.9)	0.061
≥25	12	10 (83.3)		5 (41.7)
Age, y
35–44	18	16 (88.9)	0.301	12 (66.7)	0.407
45–54	7	7 (100.0)		4 (57.1)
55–64	5	3 (60.0)		5 (100)

P values are obtained from χ² tests for association between subgroups and response (yes/no).

^*Adjusted for multiple comparisons using the Benjamini–Hochberg method.

Treatment was tolerable, with a mean pain NRS score of 4.50 (95% CI, 3.75–5.18) (Table 4). Using a meta-analytic approach, we analyzed pain scores from 2 published studies^42,43 on the first-generation Ulthera device with similar treatment protocols and treatment areas (Table 4). (See table, Supplemental Digital Content 4, which displays references for legacy Ulthera studies using similar treatment protocols on face and neck, https://links.lww.com/PRSGO/E467.) These studies yielded a pooled pain score estimate of 6.15 (95% CI, 5.85–6.45). The mean pain score of participants treated with Ultherapy Prime in our cohort was lower, with the 95% CI falling outside the meta-analysis range.

Table 4.

Observed Pain Scores in the Present Cohort and Literature-based Pooled Estimates

	Present Case Series	Pooled Estimates From Studies on the First-generation Device
Sample size	30	134
Mean (95% CI)	4.50 (3.75–5.18)	6.15 (5.85–6.45)
SD	2.0	—
Median (range)	4.00 (1–10)	Not reported

DISCUSSION

Our results demonstrate the efficacy of Ultherapy Prime in improving skin laxity in the lower face and submentum of Asian populations. At D90, at least a 1-point improvement in MAS grades for neck volume and jawline occurred in most participants. When stratified by baseline severity, all (100%) participants with moderate or severe neck, or jawline sagging at baseline showed improvement at D90 compared with 77.8% of participants with mild sagging at baseline. Aesthetic changes may thus be more pronounced and visible in patients presenting with more severe skin laxity at baseline, who therefore have more room for improvement. Improvements in MAS ratings are consistent with GAIS results, which indicate that Ultherapy Prime can produce meaningful aesthetic improvements as perceived by both patients and physicians.

Factors such as BMI, sex, and age can lead to physiological differences in skin anatomy and elasticity, healing responses, or collagen remodelling⁴⁴ that may affect treatment efficacy. Our subgroup analyses showed that Ultherapy Prime effectively improved neck volume and jawline sagging, with high treatment response rates irrespective of BMI, sex, or age. The improvements in neck volume and jawline sagging seen in all male patients suggest that sex does not significantly impact treatment effectiveness. This subgroup analysis thus adds to the limited data that currently exist for Ultherapy in men⁴⁵ and indicates that outcomes are not significantly different even if physiological differences exist between male and female skin. Moreover, although previous studies reported greater improvements in individuals with lower BMI,⁴² our subgroup analysis found no significant difference in response rates between individuals with a BMI less than 25 kg/m² and BMI 25 kg/m² or greater. Similarly, no significant difference in response rates was observed between the 3 age groups, with jawline sagging improving in all cases in the oldest (55–65 y) age group. Taken together, our data suggest that Ultherapy Prime may be suitable for a range of patients across different ages, BMI, and sexes.^42,45

After treatment, the participants were asked to evaluate their treatment experience with Ultherapy Prime. Participants reported high levels of satisfaction and a high likelihood of recommending the treatment, with some citing the treatment’s noninvasive nature, minimal discomfort, and observed aesthetic improvements. In a recently published systematic review and meta-analysis of the first-generation device,^29,30 pooled GAIS improvement rates were 89% and 84% as assessed by investigators and patients, respectively. Among the patients in our cohort, 40.0% were rated as improved, 26.7% very improved, and 33.3% very much improved. Overall, all patients in our cohort were rated as at least improved based on the GAIS, suggesting that patient satisfaction with Ultherapy Prime is consistent with and potentially favorable to first-generation systems. We previously showed that the upgraded Ultherapy Prime processor is responsive, with improved workflows described by operators as faster and uninterrupted.³³ A full face and neck treatment with the first-generation device typically takes about an hour; in this study, the mean treatment time was 45.6 minutes. Seamless ultrasound image transitions and clearer real-time visualization may contribute to shorter treatment times, enhancing patient comfort and clinical efficiency. Additionally, pain scores reported in this study were lower than our pooled estimate from studies using the first-generation device with comparable face and neck treatment protocols.^42,43 It should be considered that differing individualized physician pain management with oral analgesics may confound pain scores, and additional studies on pain management protocols would be helpful. Notably, one of our participants who was not administered any pretreatment medication reported an NRS score of 10, making it reasonable to anticipate that the use of appropriate topical anesthesia or oral analgesia could have resulted in even lower mean pain scores. Ultherapy Prime’s improved visualization capabilities enable more precise energy delivery and the avoidance of sensitive structures that may lead to pain, for example, bone. The shorter treatment times in this study may also be associated with improved patient comfort and lower pain scores. Together, these findings point toward improved efficiency and patient comfort with Ultherapy Prime procedures, although further comparative studies are warranted.

This pilot case series was limited by its small cohort size, lack of objective measurements, and short follow-up period. A small cohort size may have limited our ability to detect true associations, and subjective assessments may be susceptible to influence from expectations, social desirability, courtesy bias, operator bias, or even unconscious bias through repeated engagement with a patient or procedure. The 90-day follow-up limits our capacity to determine the trend and longevity of treatment effects and patient-reported outcomes over time. Nevertheless, our results demonstrate that the clinical effects of Ultherapy Prime treatments are visible from 90 days, as documented in literature.⁴⁵ Future efforts could be directed to expand our outcomes through studies with longer follow-up periods and the use of independent, blinded evaluators to further reduce sources of bias. Our study was strengthened by the various demographic factors explored in subgroup analyses, although this was restrained by the small subgroup sizes. Further studies that enroll larger patient numbers of varied demographics (eg, different sexes and ages) would be valuable, as research on a broader range of demographics and ethnicities could help detect associations between subgroups and enhance treatment customization. Standardized pain management protocols in future studies may also confirm that the enhanced features of the updated device contribute to reduced procedural discomfort.

The safety and effectiveness of the first-generation Ulthera legacy platform have been well established within the field of aesthetic EBDs.¹³ Our case series on the updated Ultherapy Prime system provides evidence to reinforce its safety and effectiveness and also highlights potential benefits from its enhanced user experience. This is the first published case series on Ultherapy Prime, and as more data become available, future research will be better positioned for more robust comparisons between the new and legacy devices.

CONCLUSIONS

The updated Ultherapy Prime system incorporates design and technological enhancements aimed at improving operator comfort and imaging capabilities for noninvasive skin lifting. In this pilot case series, Ultherapy Prime seems to be effective and well tolerated in Asian patients across a range of Fitzpatrick phototypes, ages, BMI, and sexes.

DISCLOSURES

The Ultherapy Prime Early Experience Program was sponsored by Merz Aesthetics. All authors declare that they have received an honorarium to compensate for time spent performing the Ultherapy Prime treatments and clinical assessments. All authors were previously engaged as consultants for Merz Aesthetics. Funding for article editing and preparation was provided by Merz Asia Pacific Pte Ltd. to Dr. Shawna Tan, Medical Writers Asia. No further honoraria or payments were made for authorship or publication.

ACKNOWLEDGMENTS

Medical writing support was provided by Dr. Shawna Tan of Medical Writers Asia. Ultherapy is a proprietary technology developed by Ulthera, Inc.