Importance Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.
Deliberations of the Safety Task Force: Risk factors and treatment of adverse events associated with aesthetic injectables
AbstractBackgroundThe growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.AimsThe inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.MethodsThe STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.ResultsThe establishment of a global database for tracking filler‐related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non‐medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.ConclusionsThe STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.
Pitanguy Ligament Preservation in Structural Precision Rhinoplasty
Summary: The Pitanguy ligament is a crucial structure in nasal tip support and in maintaining the integrity of the soft-tissue envelope of the nose. In this cadaveric study, the authors dissected out the Pitanguy ligament on a series of fresh human cadaver specimens to elucidate the structure of the ligament and its fate in open rhinoplasty. The Pitanguy ligament can act as a tethering force to the nasal tip when reshaping the nasal tip. Release of the Pitanguy ligament alleviated downward tension on the nasal tip, and tip shaping to a more appropriate position demonstrated that this ligament was displaced from its ideal position. In patients seeking rhinoplasty, this structure may require release and reconstruction to successfully alter tip position and avoid supratip deformity.
Preventing Hump Recurrence in Dorsal Preservation Rhinoplasty: The 5 Key Tenets
Summary: Preservation rhinoplasty has re-emerged over the past decade and continues to gain traction in the rhinoplasty community. Dorsal preservation rhinoplasty (DPR), one of the tenets of preservation rhinoplasty, centers on preservation of the native osseocartilaginous joint of the dorsum, with changes instead achieved through modification of the underlying septal cartilage and surrounding bony nasal pyramid. However, one complication unique to DPR is the phenomenon of hump recurrence, where tensile forces or memory lead to a recurrent convexity of the dorsal hump. Hump recurrence is the most common complication after DPR and often requires revisionary surgery. Therefore, strategies to reduce the incidence of hump recurrence are highly sought after. In this article, the authors describe the senior author’s (R.J.R.) 5 main tenets of preventing hump recurrence in DPR, focusing on (1) appropriate patient selection; (2) addressing anatomic blocking points; (3) adding mechanical fixation of the cartilaginous vault with suture techniques depending on the level of septal manipulation; (4) applying a graduated approach to DPR procedural selection; and (5) ancillary measures to control the shape of the nasal dorsum. Implementation of each of these 5 tenets is crucial for modern rhinoplasty surgeons to reduce the incidence of hump recurrence in their preservation rhinoplasty practices.
One-Year Data on the Longevity and Safety of Hyaluronic Acid Filler for Static Horizontal Neck Rhytids
BACKGROUND The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HARR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION HARR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.
Superficial versus deep injections of the upper midface—A prospective interventional split‐face study
AbstractBackgroundVarious injection algorithms have been proposed in the past which are in line with the three aesthetic principles: upper face first, lateral face first, and deep regions first. However, increasing evidence is provided that the upper midface can be targeted with superficial soft tissue filler injections alone too.ObjectiveTo investigate in a prospective split‐face study design whether superficial or deep upper midfacial injections provide superior aesthetic outcomes.MethodsA total of n = 20 study participants (100% females; age 43.95 (11.7) years; BMI 22.92 (2.6) kg/m2) were treated with superficial soft tissue filler injections on side of their face and deep injections on the contralateral side with a mean volume of 0.78 cc. Outcome was evaluated at 7 weeks follow‐up for midfacial, and lower facial volume, for medial and lateral facial skin vector displacement, and for improvement of nasolabial, crow's feet, and upper cheek fullness severity scores.ResultsNo adverse events related to safety or product tolerability were observed during the entire study period. All semiquantitative scores improved statistically significantly after the observational period (p < 0.001) but displayed no difference between the two applied injection techniques (p > 0.05).ConclusionThe results of this split‐face study revealed that both the superficial and the deep cannula injection technique for midface volumization statistically significantly improve the midfacial volume, reduce nasolabial fold and crow's feet severity. No statistically significant difference was observed between the two injection techniques when compared via semiquantitative and objective outcome evaluation after 7 weeks follow‐up.
A Prospective Clinical Trial Evaluating the Efficacy and Safety of Non-Animal Stabilized Hyaluronic Acid Injections for Non-Surgical Rhinoplasty
Background: Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G’) for strong structural support with minimal integration propensity. Methods: A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3–6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. Results: A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. Conclusion: Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. Level of Evidence: Level III: Evidence obtained from well-designed cohort study.
Intralabial Lip Compartments and Their Potential Clinical Relevance
Background: Aesthetic soft-tissue filler injections for lip enhancement are popular and performed throughout the world. When injecting lips with a cannula, as the cannula is advanced, resistance is perceived in consistent locations, potentially indicating boundaries between intralabial compartments. Objective: We aimed to investigate whether intralabial compartments exist and, if so, to describe their volumes, location, boundaries, and dimensions. Methods: This cadaveric study investigated a total of 20 human body donors (13 male, seven female) with a mean (SD) age at death of 61.9 years (23.9) and body mass index of 24.3 kg/m2 (3.7). The investigated cohort included 11 White donors, eight Asian donors, and one Black donor. Dye injections simulating minimally invasive lip treatments were conducted. Results: Independent of sex or race, six anterior and six posterior compartments in the upper and lower lip were identified, for a total of 24 lip compartments. Compartment boundaries were formed by vertically oriented septations that were found in consistent locations. The anterior compartments had volumes ranging from 0.30 to 0.39 cc; the posterior compartment volume ranged from 0.44 to 0.52 cc. The compartment volumes were larger centrally and decreased gradually toward the oral commissure. Conclusions: The volume and size of each of 24 compartments contribute to the overall appearance and shape of the lips. To achieve a natural lip shape preserving aesthetic outcome it may be preferable to administer the volumizing product using a compartment-respecting injection approach.
Applied Anatomy of the Lower Eyelid Preseptal Space for Treating Ectropion and Retraction with Soft-Tissue Fillers
Background: Lower eyelid malposition can result from age-related changes, such as ectropion, or postsurgical changes, such as retraction after lower lid blepharoplasty. The current accepted treatment is surgical, but soft-tissue fillers have been used as well, with good outcome. The underlying anatomy, which is incompletely described, would be useful information for practitioners desiring to provide minimally invasive injections of the lower eyelid. The authors describe a minimally invasive injection technique adjusted to the complex anatomy of the lower eyelid for the treatment of ectropion and retraction of the lower eyelid. Methods: A total of 39 periorbital regions of 31 study participants were retrospectively analyzed using photographs before and after reconstruction of the lower eyelid with soft-tissue fillers. Two independent raters assessed the degree of ectropion and lower eyelid retraction (0 to 4, best to worst) before and after the reconstruction and the overall aesthetic improvement using the Periorbital Aesthetic Improvement Scale. Results: The median degree of ectropion and lower eyelid retraction score improved statistically significantly from 3.00 (SD, 1.5) to 1.00 (SD, 1.0) (P < 0.001). The mean volume of soft-tissue filler material applied per eyelid was 0.73 cc (SD, 0.5). The median Periorbital Aesthetic Improvement Scale score after the treatment was rated as 4.00 (SD, 0.5), indicating improvement of the periorbital functional and appearance. Conclusions: Anatomic knowledge of the lower eyelid and of the preseptal space is of clinical relevance when reconstructing the lower eyelid with soft-tissue fillers. The targeted space provides optimal lifting capacities for improved aesthetic and functional outcome. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Pharmacologic and Other Noninvasive Treatments of the Aging Face: A Review of the Current Evidence
Summary: Aging of the face is the result of the interrelation of three-dimensional changes occurring over time among the 5 different layers of the face and its associated structures. Knowledge regarding the causes of these changes and identification of new key anatomic structures have helped elucidate one of the most complex areas of the human body. This has resulted in the introduction of pharmacologic agents to help stop, mitigate, or counteract signs of aging and restore the youthful appearance of the face. The authors performed a systematic search of the literature to review the current highest-level evidence of facial antiaging pharmacologic agents. Pharmacologic and minimally invasive antiaging treatments can target different components of facial aging and continue to evolve. With continuous research efforts, traditional treatments, such as botulinum toxin type A, injectable fillers, and chemical peels, are emerging in newer, more effective formulations, with longer lasting clinical results. However, for soft-tissue descent and facial volume loss, surgery remains the standard treatment. An adequate understanding of the three-dimensional process of facial aging over time (the fourth dimension), facial anatomy, and the pharmacologic properties of antiaging/rejuvenation agents are the sine qua non of facial antiaging treatment. The specific modality should be tailored to patient characteristics, preferences, and goals.