A prospective,open‐label,multicenter, observational,postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips

Hyaluronic acid (HA)‐based injectable fillers three‐dimensionally restore the natural contours of the lips and perioral area, thereby reducing some signs of aging lips. To evaluate the short‐term aesthetic impact of treatment with the HA dermal filler Juvéderm^® VOLBELLA^® with Lidocaine, formulated utilizing VYCROSS^? technology, for enhancement or correction of asymmetry of the lips, evaluated using a patient‐centric approach. Sixty‐two subjects were enrolled in this study, conducted at two sites in Germany. Primary endpoints were satisfaction with improvement, look and feel of the lips, assessed by subject and physician at first visit and 4 weeks post‐treatment. Immediately after injection at first visit, 83.6% of subjects were Extremely Satisfied, Very Satisfied or Satisfied with improvement in the lips, which increased to 94.1% and 93.0% of subjects with/without top‐up treatment at follow‐up, respectively. After injection at first visit, 61.7% of subjects rated the look and feel of their lips as Extremely Natural or Very Natural, which increased to 75.0% and 93.0% of subjects with/without top‐up treatment, respectively. The HA dermal filler was associated with minimal discomfort, bruising or swelling of the lips; almost two‐thirds of subjects (62%) returned to social engagements on the same day. The high degree of subject satisfaction with aesthetic improvement in the lips, as well as the natural look and feel, indicates that this HA dermal filler represents an effective treatment option for patients requiring lip enhancement.     

A European evaluation of cosmetic treatment of facial volume loss with Juvéderm™ Voluma™ in patients previously treated with Restylane Sub-Q™

Background Juvéderm? VOLUMA? (Voluma) is a new injectable, long‐lasting, resorbable hyaluronic acid filler. It restores facial volume, resulting in a more youthful appearance. Aims To evaluate current in‐market perceptions of the aesthetic result and use of Voluma. Patients/methods Men and women >30 years who had received Restylane SubQ? (Restylane) <2 years previously, now requiring re‐treatment and who consented to Voluma treatment were included. Results Eighty‐four patients (mean age 51 years, 88% women) were recruited. The mean total volume of Voluma injected was 2.73 mL/patient. This included treatment to both sides of the face, specifically in the malar and chin areas or both (mean 1.36 mL each to the right and left sides of the face). Seventy‐five percent of injectors found Voluma fairly/very easy to inject and 84.5% found it easy to sculpt/massage. Most patients (98%) and physicians (98%) rated the aesthetic effect of Voluma as improved. Injectors rated Voluma as better than previous Restylane use in 69.1% of patients (P < 0.001), and preference for Voluma was expressed in 61% of patients (P < 0.001). Ninety‐nine percent of injectors would recommend Voluma to colleagues and patients (100%); 96.4% of patients would recommend it to friends. Treatment was well tolerated. Conclusions Voluma is easy to use, sculpt, and massage. Physicians and patients rated the cosmetic effects highly, and both groups reported a preference for Voluma in those patients previously treated with Restylane.     

European evaluation of a new hyaluronic acid filler incorporating lidocaine

Background A new dermal filler has been developed with preincorporated lidocaine for the treatment of moderate/severe wrinkles. Aims Injector and patient evaluation of comfort and aesthetic results obtained with a new hyaluronic acid filler incorporating lidocaine (HAL) following treatment of nasolabial folds. Patients/Methods Three thousand five hundred and sixty‐six patients were recruited by 485 injectors across 16 countries. All patients had previously received facial fillers but now required further treatment. All patients received the new hyaluronic acid filler incorporating lidocaine. Results Injector assessment of HAL was that it was very easy to inject in > 75% of patients, and postinjection sculpting/massaging was very easy in most patients (> 70%). Both injectors and patients reported low patient pain levels, with patients experiencing less pain during all stages of the HAL injection procedure compared to previous dermal fillers. Over 95% of injectors rated the aesthetic effect of HAL as “excellent” or “good,” with 99.1% stating they would recommend treatment to a colleague and 99.4% recommending treatment to other patients. More than 90% of patients were happy with the treatment, and 99% would recommend HAL to friends. Conclusions The new hyaluronic acid filler incorporating lidocaine provides a more comfortable injection experience and improved aesthetic result for most patients compared with other dermal fillers used previously.     

Classifications and injection strategy for lip reshaping in Asians

Filler injections have become very popular in recent decades. Of the various injection procedures, lip injection is an important aspect of filler injection, especially for Caucasian patients. Asians tend to have fuller lips than Caucasians, necessitating a different approach to lip injection. Classification systems for the lip for aesthetic treatment purposes can help a physician assess a patient accordingly, and a simple classification of Asian lips into four types for injection approaches is proposed in this paper. Each patient type is discussed in terms of trait and categorization, injection area, injection techniques, injection goals, and sample patients with treatment results.     

Idiopathic lymphoplasmacellular mucositis of the lips: A case report and review of the literature

Idiopathic lymphoplasmacellular mucositis (ILPM) is a group of disorders histologically characterized by dense infiltrates of lymphocytes and plasma cells in submucosa. These lesions were initially observed on the glans penis and vulva, and later on buccal mucosa, lips, gingiva, tongue, epiglottis, larynx and other mucosal surfaces have also been reported. We have reviewed the previously reported cases of ILPM with lip involvement, outlining the clinical presentation, treatment and outcome of the entity to date. The etiology of ILPM is unknown, and the diagnosis is largely one of exclusion. To date, no consensus or consistently effective treatment for ILPM is available. Herein, we report an 18‐year‐old woman presented with markedly swollen lips with severe erosions, bleeding and yellow to black crusts who was diagnosed to have ILPM by histopathological study. The case occurred on rare lip site with an unusual appearance. Various treatment modalities were tried, but the responses were unsatisfactory and the lesion only responded to long‐term administration of oral steroids.     

A potential relationship between skin hydration and stamp‐type microneedle intradermal hyaluronic acid injection in middle‐aged male face

There is an increasing interest in skin rejuvenation using hyaluronic acid (HA) fillers beyond the improvement of deep wrinkles and volume deficiencies, which have been primary research foci in the past. We conducted a pilot study using a sample of six middle‐aged male subjects. Using an automatic intradermal injector with 0.020 mL of material contained in each injection point with a total of 100 points, 2 mL of non‐cross‐HA filler was injected into the entire face at every treatment session. We administered injections of HA for a total of three sessions per subject at 2‐week intervals and evaluated the results using a corneometer, TEWL, cutometer, measures of patient satisfaction, and the global aesthetic improvement scale (GAIS). Corneometer values increased steadily at each measurement, while the average value of TEWL increased in comparison with baseline after each application of the procedure. However, values returned to readings similar to those at 4 weeks after complete termination of the procedures. Cutometer values differed between the baseline and after procedures. All patients were assessed as “very much improved” or “much improved” according to GAIS, and all were pleased with the outcomes of treatment in terms of the enhancement of moisture, elasticity, and brightness.     

Long-term patient satisfaction with cosmetic outcome of minor cutaneous surgery

We evaluated our patients' own assessment of the cosmetic outcome of minor dermatological surgery procedures. A postal questionnaire was sent to patients who had undergone surgery between 12 and 18 months previously. Patient satisfaction was correlated with variables, including age, sex, lesion size and site, indication for excision, histological diagnosis and operator. Two hundred and seven excisional procedures were identified in 193 patients. Seventy-nine per cent of the questionnaires (163/207) were returned. Seventy per cent of patients reported that the scar was invisible or better than expected and 9% rated it to be worse than expected. Ninety per cent of patients said they would undergo the procedure again. Patient dissatisfaction was associated significantly and independently with excisions from the back, younger age and benign histology.     

A technical approach for redefinition and volumization of lip area with hyaluronic acid: A case series

Background and Aim

Non-surgical procedures using injectable filler products for perioral rejuvenation have emerged and evolved rapidly to become one of the most frequently performed aesthetic treatments. We report a case series describing the administration of two hyaluronic acid-based dermal fillers (HA filler) with excellent characteristics and formulation using a technique developed by the author.

Patient/Methods

We describe a series of nine female subjects who underwent perioral rejuvenation performed by a single physician in her private clinic. The HA filler (Alaxin® FL or Alaxin® LV) was injected into the lips using the specially developed Clodia technique. Patients were given post-treatment advice for optimal results. Patient- and investigator-perceived outcomes were rated using the Global Aesthetic Improvement Scale (GAIS) and adverse events (AEs) were collected.

Results

All subjects described the injection method as painless and well tolerated, as shown by the immediate post-treatment photographs. Mean GAIS scores for both the patients and the investigator were 4.8/5, indicating significant improvement 12 months after the treatment. No AEs were reported during follow-up. The HA filler showed a high degree of dermal integration in all subjects, and the investigator reported excellent handling and injection properties.

Conclusion

Perioral rejuvenation with an HA filler administered using the developed injection technique gave highly satisfactory results in all subjects and was not associated with AEs.     

Clinical outcomes after lip injection procedures—Comparison of two hyaluronic acid gel fillers with different product properties

Background

Transient swelling is common after lip injections with hyaluronic acid (HA) based fillers. Swelling and other injection-site reactions may relate to the injection procedure itself, or to gel properties, which differ between fillers due to differences in manufacturing methods.

Objectives

To evaluate safety and effectiveness of lip injections with two HA fillers manufactured using different gel technologies.

Methods

In a study sample of 40 subjects, treatment with two soft tissue filler product (HA_RK or HA_JUS) was randomly assigned. Subjects were injected with 0.5 cc per upper and lower lip using a standardized injection procedure. Early-onset adverse events (AEs) were assessed by evaluation up to Day 14. Aesthetic improvement, subject satisfaction, and AEs post-Day 14 were assessed up to 24 weeks.

Results

In subjects treated with HA_RK, the intensity of early onset swelling, erythema, and pain/tenderness was lower than in subjects treated with HA_JUS. Aesthetic improvement was achieved in both groups, and most subjects were satisfied with the appearance of their lips. Treatment-related AEs post-Day 14 mostly related to the implant site; most were mild-to-moderate, and none were serious.

Conclusions

The intensity of early-onset swelling, and other injection-site reactions was lower in subjects treated with HA_RK than in subjects treated with HA_JUS. Since both the injection volume and injection procedure were standardized, the difference in local tolerability between the two HA fillers may relate to differences in gel properties. Aesthetic improvement, subject satisfaction, and AE profiles post-Day 14, however, were similar between filler groups.     

Treatment of scalp psoriasis with clobetasol‐17 propionate 0.05% shampoo: a study on daily clinical practice

Background Safety and clinical effectiveness of clobetasol‐17 propionate 0.05% shampoo have been shown in patients with scalp psoriasis. Aim First, to evaluate treatment satisfaction, user convenience safety and effectiveness of clobetasol‐17 propionate 0.05% shampoo treatment in daily clinical practice. Second, to identify subgroup variables that may predict treatment success or failure. Methods A total of 56 patients with scalp psoriasis were treated with short‐contact clobetasol‐17 propionate 0.05% shampoo once daily for 4 weeks. Data on treatment satisfaction, user convenience, safety and effectiveness were assessed on a 7‐point Likert scale using postal questionnaires. Subgroup analyses were performed to identify variables that may predict treatment outcome. Results A total of 41 patients returned both questionnaires (73%). Positive treatment satisfaction and user convenience were reported by 66% and 79% of patients respectively. Patient‐rated indicators for disease severity improved by 39–46% (P < 0.05%). No major side‐effects were reported. Subgroup analyses did not reveal any statistically significant patient variable that may predict treatment outcome. However, a tendency towards improved treatment satisfaction was observed in patients who had received fewer topical antipsoriatic treatments previously (P > 0.05). Conclusions Short‐contact treatment with clobetasol‐17 propionate 0.05% shampoo has high user convenience and patient satisfaction rates. Moreover, the treatment is well‐tolerated and efficacious from patients’ perspective. Subgroup analyses did not reveal factors predicting treatment outcome, although treatment success tended to be more evident in patients who had received fewer treatments previously.     

Studying the satisfaction of patients on the outcome of an aesthetic dermatological filler treatment

Background Many factors contribute to extend productive life in the modern world. Competition makes people worry about physical appearance, mostly in respect to facial and skin aging. This has motivated new developments in cosmetic dermatology and the need of evaluating patient satisfaction with the new proposed treatments. Poll questionnaire has been used for such evaluation, and the analysis of the electroencephalogram (EEG) mapping obtained while the patient answers the satisfaction questionnaire may render the results less subjective. Objectives The purpose of this paper is to study the satisfaction of a group of 33 women (mean age, 44 years) treated with hyaluronic acid filling of nasolabial folding or lips, combining the EEG brain mapping and questionnaire techniques. Methods At the third month of evaluation, two networked personal computers were used for the EEG recording and for presenting the patient with a questionnaire about her well‐being feeling; self‐evaluation of her face; her satisfaction with the results of the aesthetic treatment; how the family, friends, and people at work evaluated the result of the treatment; and her decision to repeat the treatment and to recommend it to friends and family. Results Poll results showed that patients were feeling well and were satisfied with the results of the aesthetic treatment. Furthermore, the regression EEG mappings showed patients to be satisfied with their appearance and with the treatment involving similar brain areas. Conclusion Patients decided to undergo the treatment because they were already considering it (54%) or because they were dissatisfied with their lips or nasolabial folding (52%). The fact that the treatment was free of charge solidified the decision. Patients consider themselves as good‐looking and they wanted to preserve such a condition.     

Isolated lichen planus of the lip

Lichen planus (LP) is an inflammatory disease that may involve multiple skin sites as well as mucous membranes, hair follicles and nails. It rarely occurs on the lips and usually then in association with oral lesions. We report a 43-year-old man with a 7-month history of inflammation and erosive lesions of the lower lip. Histopathological and immunofluorescence studies showed features of LP. Local treatment with betamethasone dipropionate 0.5% ointment led to complete resolution within 1 month. Four months later, the patient developed typical cutaneous LP. Isolated LP of the lip is unusual, although this condition may be underestimated and therefore under-reported in the literature.     

Non-surgical rhinoplasty technique: An innovative approach for nasal reshaping with hyaluronic acid fillers

Objective

Nonsurgical rhinoplasty has become increasingly popular among patients who want to improve the aesthetic aspects of their nose and do not accept the risks and/ or cost of surgical rhinoplasty. The main goal of the current paper was to present the preliminary aesthetic and clinical outcomes of an innovative injection technique for nose sculpturing with hyaluronic acid (HA) filler.

Methods

Retrospective analysis of a prospective clinical registry of patients who attended one of the study centers and were candidates for non-surgical nose reshaping between October 2019 and November 2020. A 25 mg/mL HA filler was administered, in all the cases, by using a syringe with a fixed microneedle (30G/8mm). All patients were injected at three key nose points with the following order: (1) Tip (maximum HA injected 0.2 mL); (2) columella (maximum HA injected 0.3 mL); and (3) Radix and Dorsum (maximum HA injected 0.3 mL). Degree of patient satisfaction with the treatment was assessed by using a five-points Likert scale. The primary endpoint was the degree of patients' satisfaction 12 months after treatment.

Results

One-hundred-and-one patients (91 women) were included in the study. Fifty-six (56%) patients underwent a unique treatment-session and 44 (44%) subjects needed an additional touch-up. Eighty-five (84.2%) patients were very satisfied with the treatment results. Six (5.9%) patients reported moderate adverse events, which were successfully controlled with medical therapy.

Conclusions

Our nose sculpturing technique, by using hyaluronic acid filler, was an effective, predictable, and relatively safe procedure, that obtained a high degree of patient satisfaction.     

Longevity of effects of hyaluronic acid plus lidocaine facial filler

Background  A new hyaluronic acid filler containing pre-incorporated 0.3% lidocaine reduces pain and enhances patient comfort. In vitro studies confirm functional equivalence with non-lidocaine-containing products, but only limited data are available on the long-term effects of lidocaine on filler performance in the clinical setting.
Aims  To investigate whether inclusion of lidocaine impacts the longevity of hyaluronic acid fillers.
Patients/Methods  60 patients with moderate–severe bilateral nasolabial folds received 24 mg/mL hyaluronic acid with pre-incorporated lidocaine or an equivalent product without lidocaine and were followed-up for up to 76 weeks.
Results  Significantly better results were found in favor of HA gel with pre-incorporated lidocaine for physician assessment of injection pain and patient pain assessment after injection (both P  < 0.001). Long-term follow-up of patients after almost a year showed that 91% (52/57) of patients had no evidence of facial asymmetry, and investigators confirmed lidocaine had no effect on filler longevity. High levels of patient satisfaction and prolonged benefits due to persistence of the product were noted, with those patients needing additional treatment requiring 'top-up' rather than full re-treatment.
Conclusions  The addition of 0.3% lidocaine does not affect product longevity and the small volume required for 'touch-up' also suggests that longevity is maintained.     

Adverse effects of isotretinoin: A large,retrospective review

Acne is a very common and disfiguring disease that affects mostly adolescents and, to some extent, adults. The objective of our study was to estimate the adverse effects after isotretinoin by treatment of 3,525 patients due to acne vulgaris in a 5‐year observation. Retrospective, comparative study was carried out in Poland and Romania from January 2012 to August 2016. Inclusion criteria into this study were moderate, severe, and nodulocystic inflammatory acne vulgaris. Exclusion criteria were mild acne, pregnant, and lactating women. Statistical analysis was carried out using T test and Chi square. All patients were treated with oral isotretinoin. Patient age ranged from 13‐35 years. Dry lips was the most commonly reported adverse effect, affecting 100% of users, followed by xerosis (94.97%) and facial erythema (66.21%). Of all adverse effects, psychiatric symptoms accounted for 25.16%; eye lesions accounted for 8.96%. In lab investigations an increase in the level of total cholesterol and serum triglycerides was observed. This study documents the adverse effect profile of isotretinoin in a large number of patients collected over a period of 4 years. Side effects were mild and well tolerated and did not necessitate stopping the treatment. However, it is important to educate patients about this potential consequence.     

3D Photography and lip filler: A novel assay

Background: Injectable fillers have been used for a considerable number of years in aesthetic dermatology, including the use of lip augmentation. There has been little attempt to scientifically measure the degree of filler augmentation. Methods: We report the use of novel photography utilising three‐dimensional imagery (Surface Imaging Ltd and Canfield Scientific Vectra 3D Volumetric Analysis System) for evaluating the change in lip volume before and after injection of filler. Results: This is a single‐patient case report where computerised three‐dimensional photography was taken and subsequently analysed. The increased volume was then measured following lip augmentation with a hyaluronic acid filler (Restylane^TM). Conclusions: This system would seem to have the potential for analysing the change of volume both for different parts of the face and, in this instance, for lips. Further studies are required and are ongoing to examine its accuracy to measure volume enhancement with other fillers.     

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area

Background

Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers.

Aims

To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines.

Materials and Methods

This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS).

Results

In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up.

Conclusions

The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.     

Clinical features and management of schwannoma affecting the upper and lower lips

Head and neck schwannomas comprise 25–40% of all schwannomas, with presentation on the lips as the rarest and most surgically complicated site for perioral tumors. A systematic literature review was conducted to include 21 cases of patients with schwannoma of the upper or lower lips. The majority of patients presented with a single, painless, well‐encapsulated nodule on the upper or lower lips. The nodules were consistently slow‐growing, with an average 29.3 months from symptom onset to clinical presentation. Most cases were complicated by profound cosmetic disfigurement as well as dysphagia, dysarthria, snoring, and/or sleep apnea. Overall, histological analysis was consistent with classic schwannoma, and all cases were treated via complete surgical excision, and for malignant tumors, additional therapy was utilized. All but four cases achieved full remission by final follow‐up. Recurrence rate for benign lip schwannomas was 5.3%, which is remarkably different from the standard recurrence rate of 8–24% for benign peripheral schwannomas. Additionally, the proportion of malignant tumors was greater for lip schwannomas than other schwannomas. Lip schwannomas demonstrate different characteristics than schwannomas from other locations on the body, and these remarkable differences highlight significant implications for clinical practice. Complete excision is the primary mode of treatment with overall excellent postoperative prognosis and rare instances of recurrence. Given the rarity of this tumor, this review of available cases serves to comprehensively describe clinical presentation and surgical treatment approaches to upper and lower lip schwannomas.     

p53, cyclin-D1, PCNA, AgNOR expression in squamous cell cancer of the lip: a multicenter study

BACKGROUND: The development of squamous cell carcinoma of the lower lip is an interesting model of photocarcinogenesis because of the structural and topographic characteristics of the lips. The purpose of this study was to evaluate the expression of immunohistochemical markers on the lips of patients with lower lip squamous cell carcinoma (LLSCC), compared with a control population. METHODS: Of the 98 subjects involved in the study, 58 were suffering from squamous cell carcinoma of the lower lip. The remaining 40 acted as a control. The case studies were taken from six university and hospital dermatology and plastic surgery departments. Questionnaires were administered to assess the risk factors for LLSCC. The cases involving squamous cell carcinoma underwent surgical excision and punch biopsy specimens were obtained from 20 control patients. Tissues were prepared in 5-microm-thick sections to carry out the following immunohistochemical study: PCNA, p53, AgNOR, cyclin-D1, bcl-2. RESULTS: The lower lip was the predominant location of squamous cell carcinoma, with the following factors playing important roles: chronic sun exposure, history of smoking, alcohol use and familial risk of cutaneous tumors. The male/female ratio in our survey was 5:1. The p53 protein was positive in approximately 50% of SCC cases and in 20% of controls. This protein is mostly associated with chronically photoexposed skin areas. AgNOR positivity increased with the loss of cellular differentiation; a progressive increase in size and a poorly defined shape were evident in poorly differentiated carcinomas. CONCLUSIONS: The results of this multicenter study showed that there is a noticeable difference in the expression of PCNA, p53, cyclin-D1, and AgNOR in tissues from patients with LLSCC and controls.