Lip assessment scores were summarized by treatment and visit.
Patient disposition and demographic characteristics were previously described.2
For patients initially treated with SGP-HA, 97.7% (2351 of 2406) of lip texture assessments throughout the study were normal, 1.6% (38 of 2406) mildly abnormal, and 0.7% (16 of 2406) moderately abnormal. The moderately abnormal lip texture findings returned to normal within 4 weeks. One patient had severely abnormal lower lip texture at Week 4 that returned to normal by Week 8. This patient assessed the lip appearance as improved from baseline at Week 4 and expressed satisfaction with the treatment result despite the abnormal lip texture. In patients who received their first or second injection at 24 weeks, 93.6% (925 of 988) of assessments of lip texture for the upper and lower lips were normal at 72 hours posttreatment and subsequent visits, whereas 6.3% (62 of 988) were mildly abnormal. One patient with moderately abnormal upper lip texture 72 hours after the second injection returned to normal within 2 weeks. The great majority (99.7%; 313 of 314) of assessments of lip texture were normal at 4 weeks after the 6-month treatment.
For patients initially treated with SGP-HA, 91.3% (2196 of 2406) of lip firmness assessments throughout the study were normal, and 8.7% (209 of 2406) were mildly abnormal. Moderately, abnormal lip firmness was reported in 1 patient treated with SGP-HA at 72 hours after initial treatment and returned to normal by Week 4. No patient treated with SGP-HA had severely abnormal lip firmness at any time. For patients who received their first or second injection of dermal filler at 24 weeks, 89.1% (882 of 990) of lip firmness assessments were normal at 72 hours posttreatment and at subsequent visits, whereas 10.9% (108 of 990) were mildly abnormal. The majority (95.6%; 302 of 316) of assessments of lip firmness was normal at 4 weeks after the 6-month treatment; remaining abnormalities were mild.
At baseline, 6.7% (9 of 135) of patients in the group to be initially treated with SGP-HA had mild upper-lip asymmetry, and 0.7% (1 of 135) had mild lower-lip asymmetry. After the first injection of SGP-HA, 91.8% (2208 of 2406) of symmetry assessments were normal, 7.4% (177 of 2406) were mildly abnormal, and 0.5% (11 of 2406) was moderately abnormal. Severely abnormal lip symmetry was observed infrequently (0.4%; 10 of 2406); these events typically resolved within 4 weeks. Ten patients in the SGP-HA treatment group had mild lip asymmetry at baseline, and most were corrected after their injections. For patients who received their first or second injection of dermal filler at 24 weeks, 86.4% (855 of 990) of symmetry assessments for the upper and lower lips were normal at 72 hours posttreatment and at subsequent visits, whereas 11.6% (115 of 990) were mildly abnormal, 1.4% (14 of 990) were moderately abnormal, and 0.6% (6 of 990) was severely abnormal. The majority (94.6%; 299 of 316) of assessments of lip symmetry was normal at 4 weeks after the 6-month treatment; remaining abnormalities were mild (5.1%; 16 of 316) or moderate (0.3%; 1 of 316).
For patients initially treated with SGP-HA, most device palpability assessments throughout the study yielded normal findings of not palpable (13.5%; 289 of 2136) or palpable with expected feel (85.9%; 1834 of 2136), whereas few abnormal findings of palpable with unexpected feel were recorded (0.6%; 13 of 2136). Device palpability decreased over time. Small gel particle hyaluronic acid was palpable with expected feel for 90.2% (220 of 244) of assessments at Week 8 but 61.6% (143 of 232) at Week 24. This palpability with expected feel was directly associated with the degree of augmentation seen, and the gradual decrease was thought to be consistent with the expected resorption of the implant. Patients in the no-treatment group were eligible to receive their first treatment with SGP-HA at Week 24, after which the device was either not palpable (10.2%; 101 of 990) or palpable with expected feel (89.4%; 885 of 990) at most assessments. Unexpected feel of the product occurred in 0.4% (4 of 990) of assessments between 72 hours posttreatment and Week 4 (i.e., after initial treatment and retreatment at 6 months) and was managed by massaging the lips to create more uniform density of the product.
All patients successfully pronounced the list of 10 specified words, except that the assessment of some words was inadvertently omitted for 1 patient at Week 16 (SGP-HA group), 2 patients at Week 24 (1 in each group), and 1 patient at Week 4 after a second treatment with SGP-HA at 6 months.
All patients at all assessments were able to drink water through a straw and therefore were rated as having normal lip function.
All patients exhibited normal lip sensation at all visits using the cotton wisp test. Lip sensation according to the monofilament test was decreased in 1 patient in the SGP-HA group at Week 12 and in 1 patient in the SGP-HA group at Week 16. Lip sensation using the monofilament test was normal at all subsequent assessments.
One patient developed a mass on the upper lip 2 weeks after a second SGP-HA treatment at 6 months. The mass (a mucocele; not treatment-related) was successfully managed by drainage, and the lip returned to normal by the next follow-up visit at 4 weeks. All other assessments revealed no mass formation on the lips.
Ease of Repeat Injection
Injection was no more difficult at the second treatment compared with the first in 91 of 93 cases (97.8%). In 2 patients, the second injection was more difficult presumably because of the presence of dermal filler; however, both patients expressed treatment satisfaction at the next follow-up visit.
The present results further demonstrate the safety and tolerability of SGP-HA in adult patients undergoing aesthetic lip augmentation. Lip safety assessments were extensive, covering a number of visual, tactile, and functional components important for appearance, normal daily activities, and patient satisfaction. This study represents the first use of an extensive battery of lip assessments to evaluate the safety of a dermal filler for aesthetic lip augmentation.
The lip safety assessments reported here are based on a set of stringently defined outcomes using scientifically grounded principles. All assessments were performed by research site staff who had received training to understand the meaning of the assessment scales and to describe functional lip abnormalities using these assessment scales. Most abnormal findings reported in this study were mild in severity and transient, consistent with previous observations.4–6 At least some of the abnormalities of lip texture, firmness, and symmetry in this study were likely to be due to swelling after injection, which is a common procedure-related event. Posttreatment lip asymmetry may result from a lack of injector expertise or by posttreatment product displacement; however, patients may present with anatomic asymmetry or with pseudoasymmetry caused by the action of facial muscles. The palpability of SGP-HA with expected feel tracks well with the previously reported efficacy of SGP-HA for lip augmentation.2 However, the presence of dermal filler may rarely affect the ease of injection and should be assessed by injectors before retreatment.
Risk-benefit considerations are important to patients seeking aesthetic augmentation procedures. Among patients with any abnormal lip assessments in this study, nearly all (99%) had ratings of improved or better on the Global Aesthetic Improvement Scale and the majority of patients (77%) chose to receive retreatment. These findings indicate that SGP-HA has an acceptable risk–benefit profile.
Although this study demonstrates the utility of this battery of lip safety assessments, the results should be viewed in light of certain limitations. For example, the comparator was no treatment. Also, these assessments inevitably contain some subjective components that depend on the training and experience of the evaluators to accurately distinguish normal from abnormal results and to grade degrees of functional impairment from mild to severe. Also, because some patients may have some limitations of lip function or asymmetry before treatment, the same evaluator should evaluate the patient at baseline and follow-up whenever possible.
The functional lip safety assessment results used in the pivotal study for SGP-HA reported in this article allow physicians to fully communicate potential risks and complications before injection.
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© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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