The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study.

INTRODUCTION: A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine. STUDY OBJECTIVES: To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures. METHODS: A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting. RESULTS: In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients. DISCUSSION: Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs. CONCLUSION: Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).

J Drugs Dermatol. 2018;17(4):413-418.

Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.

Multisource radiofrequency for fractional skin resurfacing-significant reduction of wrinkles.

BACKGROUND: Skin roughness, color change, wrinkles and skin laxity are the main characteristics of aging skin. Dermatologists and plastic surgeons look for a treatment that will provide both epidermal resurfacing for the improvement of skin roughness and deep volumetric heating that will trigger collagen remodeling in the dermis to reduce wrinkles and skin laxity. These goals should be achieved with minimal pain and downtime. METHODS: The study included 10 subjects (Fitzpatrick's skin type 2-3) with Fitzpatrick wrinkle and elastosis scale of 5-8 (average 7.3). Treatment was done with the Fractional skin resurfacing handpiece of the EndyMed PRO multisource radiofrequency system (EndyMed Ltd, Cesarea, Israel). Treatment was repeated each month up to a total of three treatment sessions. Patients photographs were graded according to accepted scales by a board certified dermatologists. Patients' pain and satisfaction were scored using dedicated questionnaires. Doctors' satisfaction was also evaluated. RESULTS: Post treatment skin erythema was noted in all treated patients, lasting up to 10 hours. Fifty six percent of patients reported no pain after treatment, and the rest (44%) reported minimal pain. All patients showed significant reduction in the Fitzpatrick wrinkle score. Average Fitzpatrick wrinkle score was 7.3 at baseline, 4.9 at 1 month after the first treatment, 4.2 at 1 month after the second treatment, and 4.1 at 1 month after the third treatment. The score was similar at 3 months after the third treatment with a score of 4.1. When asked at the end of three treatment sessions, all patients answered they will recommend the treatment to their friends (66% "definitely yes" and 33% "yes"). When asked the same question 3 months after the end of treatment, all patients (100%) answered "definitely yes".

Clinical equivalence of conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa): 2012 multidisciplinary French consensus in aesthetics.

Botulinum neurotoxins are the most popular non-surgical treatments for aesthetic indications, but there is uncertainty about whether certain formulations are comparable in efficacy and safety and can be substituted for one another by a simple one to one dose conversion ratio. An expert panel of French practitioners was convened to establish a consensus on the clinical equivalence in efficacy and safety of OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa). The consensus was divided into three sections incorporating a biological, bibliographic and clinical analysis of the two toxins. This included a review of the published data that have directly compared the two toxins for aesthetic indications and a survey of the panel's extensive clinical experience with the two toxins in terms of efficacy and safety. All panel members reviewed and endorsed the content of each section. Among this expert panel of French aesthetic physicians and biologists there was consensus that OnabotulinumtoxinA and IncobotulinumtoxinA are clinically equivalent in terms of efficacy and safety, and that a switch from one drug to the other can be made using a simple 1:1 conversion ratio.

Good tolerance of hyaluronic acid filler injections during the COVID-19 pandemic.

BACKGROUND: The aim of our study was to identify and evaluate the complications related to hyaluronic acid during the COVID-19 pandemic. METHOD: Twelve dermatologists participated in this study. A cohort and a non-cohort follow-up were ensured. RESULTS: (1) Cohort follow-up: 1041 patients. 8% had a COVID-19 infection, 27% had received COVID-19 vaccination. 2% had immediate side effects (edema, erythema, bruising). 0.5% had delayed side effects (two inflammatory nodules, one nodule without inflammation, one edema). None of these side effects occurred in the context of infection or COVID-19 vaccinations. (2) Non-cohort follow-up: 7900 syringes used. Two early side effects (inflammatory edema) were reported, of which one occurred 15 days after vaccination. Two cases of delayed side effects such as inflammation on the injected area and inflammatory nodules occurred of which one was in the context of vaccination and one during COVID-19 infection. We estimate the frequency of complications possibly attributable to the disease or to the COVID vaccination to be 0.06% in our population. DISCUSSION: Complications of HA injections in the context of COVID-19 disease or vaccination appear to be very rare but the frequency could be underestimated because of the low rate of vaccination/infection in our population. Our study shows a very good tolerance of hyaluronic acid injections during the COVID-19 pandemic.

[The new retainers in Dento-Facial Orthopedics]. / Les nouvelles contentions en orthopédie dento-faciale.

Digital technologies are gradually integrating our orthodontic practices and retainers, often less considered compared to active devices, are also benefiting. The author will give in this article a brief presentation of the various current possibilities offered by the use of digital tools for carrying out and monitoring fixed or removable retention methods. The digital workflow is perfectly suited to the production of modern and durable retainers, whether for fixed or removable devices, as well as their long-term monitoring. The objective is not to decide on the superiority of one system over another, but to expose all the possibilities for adapting the digital tool to the orthodontist's method of retention. The benefit of using digital technology is saving time and improving performance, minimizing unnecessary manipulation and improving device precision. Digital technology provides all the elements necessary to achieve new generation retainers both more simply, and for them to be more precise and more durable. These technologies are in constant progress and we can still consider improvements in the near future as software and hardware developments progress.

Assessment of the clinical efficacy of a hyaluronic acid-based deep wrinkle filler using new instrumental methods.

BACKGROUND: The efficacy of numerous hyaluronic acid (HA)-based fillers has been demonstrated by semi-quantitative and qualitative methods, useful in clinical practice, but poorly reliable. OBJECTIVE: To objectively evaluate the efficacy of a HA gel in treating nasolabial folds (NLFs) over a 9-12-month follow-up period. METHODS: A total of 47 adult patients with moderate to severe NLFs received one or two injections of HA gel. Efficacy was assessed by measuring NLF depth at time intervals up to 12 months subjectively by blind and open clinical scoring using the Lemperle scale, and objectively using skin replicas and in vivo 3D imaging methods. Tissue characterization and dermal thickness were also assessed using radiofrequency ultrasonography and high-resolution ultrasound imaging, respectively. RESULTS: The filler injection highly significantly decreased the depth of NLFs (p < 0.0001) at all time points, with an improvement of at least 1 grade in the Lemperle score in 77% and 89% of the subjects at 9 and 12 months, respectively. NLF volume measured on replicas and 3D images significantly decreased after injection and this improvement was maintained over 12 months. CONCLUSION: This HA gel is well tolerated and provides a significant and long-lasting correction of moderate to severe NLFs, as objectively demonstrated by instrumental methods.

Non-insulated Fractional Microneedle Radiofrequency Treatment with Smooth Motor Insertion for Reduction of Depressed Acne Scars, Pore Size, and Skin Texture Improvement: A Preliminary Study.

Background: Severe scarring caused by acne is associated with substantial physical and psychological distress, both in adolescents and adults. There are two basic types of scars: atrophic (depressed) and raised (hypertrophic). Microneedle fractional radiofrequency (MFRF) is a new technology that uses extra sharp microneedles to heat the depths of the dermis, which promotes dermal collagen remodeling. In this study, we used electronically controlled non-insulated microneedle radiofrequency treatment to treat atrophic acne scars, improve skin texture, and reduce pore size. Methods: Nineteen patients were enrolled in the study. The goal of the treatment was to improve acne scars and skin texture and to reduce pore size. Each patient received 2 to 6 treatments with one month intervals between treatments. Treated areas were visually assessed for skin response, including edema, erythema, and burns. We used the standard pain scale of 0 to 10 to assess pain during and after treatment. Results: All the patients completed a series of 2 to 6 treatments. No adverse events as burns, scarring, or hyper/hypopigmentation were reported. Subjective pain assessment was the average point of 1.5, as reported by the patients. The subjective and objective questionnaire revealed high satisfaction from the treatment. Conclusions: The presented study results show that the MFRF treatment provides a highly effective minimally invasive treatment for acne scars, skin texture improvement, and pore size reduction, with a short downtime and high subjective satisfaction rates.

Radiofrequency ablation for the treatment of mild to moderate obstructive sleep apnea.

OBJECTIVES/HYPOTHESIS: Obstructive sleep apnea syndrome is due to pharyngeal obstructions, which can take place at the level of the soft palate. Temperature-controlled radiofrequency ablation has been introduced as being capable of reducing soft tissue volume and excessive compliance. The aim of the study was to evaluate prospectively the possible efficacy of temperature-controlled radiofrequency ablation applied to the soft palate in subjects with mild to moderate obstructive sleep apnea syndrome. STUDY DESIGN: Twenty-nine patients with a respiratory disturbance index between 10 and 30 events per hour, body mass index equal to or less than 30 kg/m2, and obstruction at the level of the soft palate were included in a pilot, prospective nonrandomized study. METHODS: Snoring and daytime sleepiness were evaluated subjectively. Treatment (maximum of three sessions) was discontinued when the bed partner was satisfied with the snoring level. A full night recording was performed at least 4 months after the last treatment. RESULTS: Mean snoring level decreased significantly from 8.6 +/- 1.3 to 3.3 +/- 2.5 on a visual analogue scale (0-10). Daytime sleepiness decreased nonsignificantly. Mean respiratory disturbance index decreased significantly from 19.0 +/- 6.1 events per hour to 9.8 +/- 8.6 events per hour. Mean lowest oxygen saturation value increased nonsignificantly from 85.3% +/- 4.1% to 86.4% +/- 4.4%. Of the patients, 65.5% were cured of their disease. CONCLUSIONS: Temperature-controlled radiofrequency ablation was effective in selected patients with mild to moderate obstructive sleep apnea syndrome. A full-night polysomnography is required after completion of treatment to rule out residual disease.

Radiofrequency versus LAUP for the treatment of snoring.

OBJECTIVE: To compare efficacy and tolerance of controlled temperature radiofrequency and laser-assisted uvulopalatopharyngoplasty (LAUP) for the treatment of snoring. METHODS: This was a prospective, nonrandomized study on 30 patients who snored. All patients had a sleep night study. Only patients with simple snoring or mild sleep apnea and soft palate obstruction were included. Efficacy was subjectively evaluated by the bed partner 2 months after the last treatment. Tolerance was estimated daily by the patient during 18 first postoperative days. Discomfort, pain, medication intake, diet, and number of days off from work were assessed. RESULTS: Both treatments were effective on snoring. Mean discomfort and pain as well as mean intake of analgesics were significantly greater with laser-assisted uvulopalatopharyngoplasty. CONCLUSION: Controlled temperature radiofrequency was as effective as laser-assisted uvulopalatopharyngoplasty on snoring on a short-term basis but was better tolerated.

Fiber-reinforced composite anterior bridge in pediatric traumatology: clinical considerations.

This article describes the protocol for creation of a fiber-reinforced composite bridge for temporary treatment of traumatic tooth loss affecting young adult dentition. This non-invasive solution is justified by the time lapse between the end of orthodontic treatment and the moment when the state of maturity of the various tissues makes it possible to install a conventional or implant-based prosthesis.

Association between collagen production and mechanical stretching in dermal extracellular matrix: in vivo effect of cross-linked hyaluronic acid filler. A randomised, placebo-controlled study.

BACKGROUND: The effects of hyaluronic acid (HA) injection on tissue collagen anabolism are suggested to be related to the induction of mechanical stress, causing biochemical changes in skin physiology. OBJECTIVES: To ascertain the association between dermal mechanics modulated by a hyaluronic acid-based filler effect and metabolism. METHODS: Sixty females were randomised to receive a 0.5mL injection of HA gel or isotonic sodium chloride (control) in the arm. Skin biopsies were taken at baseline and after 1, 3 and 6 months. Protein and gene expression of procollagen, matrix metalloproteinases (MMP) and MMP tissue inhibitors (TIMP1) were measured blind by ELISA and qPCR, respectively. Injected volumes were measured by high-frequency ultrasound and radiofrequency analysis. Skin layer effects of injections were analysed by finite element digital modelling. RESULTS: One month after injection, the filler induced an increase in procollagen (p=0.0016) and TIMP-1 (p=0.0485) levels and relative gene expression of procollagen III and I isoforms compared with the controls. After 3 months, procollagen levels remained greater than in the controls (p=0.0005), whereas procollagen expression and TIMP-1 and MMP content were no longer different. Forty-three percent of the injected filler volume was found at 1 month, 26% after 3 months and 20% after 6 months. LIMITATIONS: The ultrasound imaging technique limited the scope of the investigation and precluded an evaluation of the action of the filler at the hypodermic level. CONCLUSIONS: Integrating both mechanical and biological aspects, our results suggest that mechanical stress generated by cross-linked HA plays a role in dermal cell biochemical response.

New protocols for the manufacture of surgical splints in surgical-orthodontic treatment.

The role of the orthodontist is important in the management of surgical-orthodontic treatment. It is particularly vital during the preoperative stage when the arches are prepared for surgery, but also in the manufacture of the surgical splints. Many tools are available to help forecast the surgical outcome and prepare the surgical splints. Some, although time-consuming and difficult to implement are still being used but are most often delegated to the prosthetics laboratory. Here, we present two innovations which provide the most precise surgical simulation achievable and which, most importantly, are the easiest to implement. The first involves the making of a set of articulator set-up plates. The second is computer-based and entails the creation of a user-friendly virtual surgical set-up.

Treatment of active acne with an Er:Glass (1.54 microm) laser: a 2-year follow-up study.

BACKGROUND: To investigate the effects of the 1.54 microm wavelength on active lesions of the face and of the back at the 2-year follow-up. METHODS: A 1.54 microm erbium:glass laser (Aramis, Quantel Medical, France) was used in combination with contact cooling set at +5 degrees C to treat acne on the face with the following parameters (3 ms, four pulses, 10 J/cm2, 2 Hz, cumulative fluence: 40 J/cm2). The laser spots were adjacent (maximum overlap: 20%) and delivered in rows in order to cover the entire area. Four treatments were performed at 4-week intervals in 25 patients with acne severity greater than 3 on the Burton scale. Acne lesion counts (papules, pustules, nodules, comedones) were performed prior to each treatment, and at 2, 4, 12, 18 and 24 months after the final treatment. RESULTS: Among the 25 patients, three were lost to follow-up, four were retreated. So, 18 patients had acne lesions counts 2 years after the fourth treatment. The mean percent reduction was 71% at the 6-month follow-up, 79% at the 1-year follow-up and 73% at the 2-year follow-up. No side effects were reported. All patients commented that their skin was less prone to oiliness. Biopsies taken after treatment showed progressive rarefaction and miniaturization of sebaceous glands and pilosebaceous follicles without morphologic damage to epidermal and dermal structures. CONCLUSION: Active acne can be successfully treated by selective dermal heating with a 1.54 microm erbium:glass laser coupled to contact cooling, with no related side effects. Furthermore, this longer follow-up study demonstrates long-term acne clearing. Combined treatments with medications (oral or topical) or light (targeting Propionibacterium acnes) may also improve acne clearance.

Treatment of neck lines and forehead rhytids with a nonablative 1540-nm Er:glass laser: a controlled clinical study combined with the measurement of the thickness and the mechanical properties of the skin.

BACKGROUND: Nonablative remodeling has been recently proposed as a new, no-down-time, anti-aging treatment. Objective. The objective was to evaluate the efficacy and safety of nonablative skin remodeling with a 1540-nm Er:Glass laser on neck lines and forehead rhytids. METHODS: Twenty female patients (mean age 45 years) were enrolled. Skin thickness and mechanical properties were measured before the first treatment, 1 month after the third treatment, 1 month after the fifth treatment, and 3 months after the fifth treatment. RESULTS: All patients reported an improvement in both skin tone and texture. Using ultrasound imaging, dermal thickness of neck and forehead increased, respectively, by 70+/-13 microm (p<0.001) and 110+/-19 microm (p<0.003). A dramatic increase of initial stress of the forehead skin (firmness) was obtained, from 7.62+/-3.68 before treatment to 16.68+/-7.44 3 months after the fifth treatment (p<0.0002). No immediate or late adverse effects were noted throughout the treatment regimen. CONCLUSION: This study demonstrates that irradiation with a 1540-nm Er:Glass laser emitting in a pulsed mode and coupled with an efficient contact cooling system increases dermal thickness and firmness, leading to a clinical improvement of neck lines and forehead rhydits.

[Psoriasis and systemic lupus erythematosus: a rare association with specific therapeutic problems]. / Psoriasis et lupus érythémateux disséminé: une association rare, des problèmes thérapeutiques spécifiques.

The association psoriasis and systemic lupus erythematosus (SLE) is a very uncommon association. We report three cases, diagnosed in an Internal Medicine department between 1993 and 2000. Few cases of psoriasis/SLE have been published in the literature. Psoriasis generally precedes the diagnosis of SLE. Psoriasis can also be associated with discoid lupus erythematosus. In some cases, SLE appears as a complication of ultraviolet phototherapy indicated for the psoriasis. The association psoriasis/SLE does not seem to have distinctive immunologic features. Specific therapeutic difficulties may occur. Indeed, hydroxychloroquine may exacerbate the psoriasis. Systemic use of corticosteroids raises the risk of severe psoriasis relapse during withdrawal. In addition, the diagnosis of psoriasic arthropathy is more difficult in this setting. The psoriasis/SLE association might be a good indication for using methotrexate.

Ultrasound imaging demonstration of the improvement of non-ablative laser remodeling by concomitant daily topical application of 0.05% retinaldehyde.

BACKGROUND: Retinaldehyde has been proven to be effective in the reduction of facial wrinkles. It has also demonstrated its usefulness when used before and after laser skin resurfacing. OBJECTIVE: A monocentric, comparative, randomized, double-blind study was performed to evaluate the efficacy of retinaldehyde versus excipient in combination with non-ablative laser remodeling treatment. METHODS: A total of 16 female patients (mean age 45 years) were enrolled for neck line and forehead rhytid treatment. They were randomly assigned into two groups. The RAL group (eight patients) was treated with a non-ablative laser (1540 nm Er:glass, 10 J/cm2 per pulse, three pulses, 2 Hz repetition rate, 4 mm spot, +5 degrees C cooling) and daily topical application of 0.05% retinaldehyde immediately after the first laser treatment and up to 3 months after the fifth treatment. The CTRL group (eight patients) was treated under similar conditions, except with a daily application of excipient. The thickness of the skin (forehead and neck) was measured by ultrasound imaging before the first treatment, 1 month after the third treatment, 1 month after the fifth treatment and 3 months after the fifth treatment. RESULTS: An increase of dermal thickness was observed for all patients treated by laser (groups RAL and CTRL) on the forehead and neck. However, the increase was greater for the RAL group (retinaldehyde) when compared with the CTRL group (excipient). Three months after the fifth treatment, the increase in dermal thickness (%) was, respectively, 5.27 versus 1.13 for the forehead and 10.54 versus 3.57 for the neck. The difference between groups was statistically significant in favor of the retinaldehyde group for the forehead (p<0.05) and of limited significance for the neck (p=0.08). CONCLUSION: When considering the reduced number of patients in each group, the statistical analysis demonstrates an evident advantage of using retinaldehyde versus excipient. This study demonstrates that irradiation with a 1540 nm Er:glass laser can be potentiated with concomitant daily topical application of 0.05% retinaldehyde.

Nonablative remodeling: a 14-month clinical ultrasound imaging and profilometric evaluation of a 1540 nm Er:Glass laser.

BACKGROUND: Nonablative remodeling has been recently proposed as a new antiaging treatment with no downtime. OBJECTIVE: To evaluate the efficacy and safety of nonablative skin remodeling with a 1540 nm Er:glass laser and contact cooling on perioral and periorbital rhytides at 14 months follow-up. METHODS: Forty-two female patients (mean age 47 years), Fitzpatrick skin types I-IV were treated five times at 6-week intervals and checked 6 months after the last treatment. Patients were evaluated using clinical data, patient satisfaction (scale 1-4), digital pictures, ultrasound imaging, and profilometry data from silicone imprints in order to quantify the degree of improvement. RESULTS: All subjects reported an improvement in the quality and visual aspect of their skin at 6 months (mean patient satisfaction 3.06/4) and at 14 months after enrollment (mean patient satisfaction 2.90/4). This was confirmed by a 43.41% reduction of anisotropy (P < 0.001) 6 weeks after the fourth treatment, reaching 44.85% reduction 6 months after the fifth treatment (P <.001). Ultrasound imaging demonstrated a 17% increase in dermal thickness (P <.001) at 6 months and 11% 6 months after the last treatment (P <.05). A lack of immediate or late adverse effects was noted at all stages of the procedure. CONCLUSION: This study demonstrated that irradiation with a 1540 nm Er:glass laser emitting in a pulsed mode and coupled with an efficient cooling system increased dermal thickness, reduced the anisotropy of the skin, and improved clinical aspects. The lack of adverse effects within the 14 months confirmed that this procedure was safe. Overall the stability of the results many months after the treatment was remarkable.