IMCAS

Subject-relevant outcomes of on-label 50U AbobotulinumtoxinA treatment for moderate-to-severe glabellar lines across three individual studies (unrestricted educational grant from Galderma)

Objectives: The 50U dose of abobotulinumtoxinA (ABO) is approved for glabellar line (GL) treatment. Here we present efficacy, subject satisfaction, and safety results from three recent clinical studies using this dose, with a focus on ≥1-grade glabellar line improvement and subject satisfaction, reflecting clinical outcomes of significance for the subjects.

Introduction: The 50 U dose of abobotulinumtoxinA (ABO) is approved for use in glabellar line treatment. Here we present results from three recent clinical trials using this dose, with a focus on ≥1-grade improvement in glabellar lines and subject satisfaction, reflecting clinical outcomes of significance for the subjects.

Materials / method: Subjects with moderate-to-severe GL were treated with 50U ABO and followed for 6 to 9 months in three studies (NCT03736928, double-blind, Phase 2; NCT03960957, double-blind, Phase 3; NCT03687736, open-label, Phase 4). Evaluations included investigator- and subject-assessed GL severity scale (GLSS), a subject satisfaction questionnaire, subject-reported onset of effect (diary), and adverse events.

Results: In each study, 80, 224, and 120 subjects were evaluated, the majority achieving improvement in GLSS. Median time to onset of effect was 2 days in all three studies. At Month 6, 53%, 46% and 37% of subjects in each study maintained ≥1-grade improvement in investigator-assessed GLSS, and at Month 9, 18% of subjects in the Phase 2 study still had ≥1-grade improvement. The majority of subjects were satisfied with their treatment and found the result to be natural-looking up to Month 6 in all three studies. Treatment-related adverse events were mostly mild, and none were serious.

Conclusion: ABO 50U for glabellar line treatment was efficacious and well-tolerated across all three studies, with fast onset, and ≥1-grade improvement and subject satisfaction lasting for up to 6 to 9 months after injection.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Subject satisfaction with AbobotulinumtoxinA for moderate-to-severe glabellar lines: a randomized, dose-escalating, double-blind study (unrestricted educational grant from Galderma)

Objectives: AbobotulinumtoxinA (ABO) is approved for glabellar line (GL) treatment using a dose of 50U. Subject satisfaction with GL treatment using higher ABO doses up to 125U vs placebo was evaluated as part of a Phase 2 study. The primary endpoint was Month 1 composite response, defined as a ≥2-grade GL severity scale (GLSS) improvement and a GLSS score of 0 or 1 assessed by both investigator and subject.

Introduction: - AbobotulinumtoxinA (ABO) is a botulinum toxin type A approved for use in glabellar line treatment using a dose of 50 U.
- Evaluation of subject satisfaction with ABO treatment for moderate-to-severe glabellar lines was undertaken as part of a Phase 2 study of single doses of ABO of 50 U, 75 U, 100 U or 125 U versus placebo (Table 1).

Materials / method: In this 9-month, double-blind study (NCT03736928), subjects received an ABO dose of 50U, 75U, 100U, or 125U, or placebo. Assessments included a subject satisfaction questionnaire, 3 FACE-Q scales (Psychological Function, Appraisal of Lines, and Perceived Age), GLSS at maximum frown, and safety. Time to return to baseline GLSS score was assessed concurrently on both investigator and subject scales.

Results: Around 80 subjects were evaluated per group. Subject satisfaction was high after treatment, >90% were satisfied with their appearance and agreed that they looked natural and appeared refreshed at Month 1. Subjects’ well-being improved, and they were less bothered about their GL and perceived themselves as younger up to Month 9. At Month 9, 18% (50U), 26% (75U), 35% (100U), 31% (125U) retained a ≥1-grade improvement (investigator GLSS). The median time to return to baseline GLSS scores was 226, 240, 252, and 256 days, respectively. Treatment was generally safe across all doses.

Conclusion: ABO was efficacious and well-tolerated across all doses from 50U to 125U, with ≥1-grade severity improvement maintained for up to 9 months. Subjects reported natural results and high rates of satisfaction, sustained to Month 9, as well as a wider positive impact on well-being and age assessment. Subject satisfaction is an aspect of clinical importance, which captures treatment effect over time.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Epidemiological analysis of the number of deaths by skin cancer, between 2016 and 2020 in Brazil

Objectives: To determine skin cancer mortality indicators in Brazil, by place of residence, in the states and regions of Brazil, between 2016 and 2020.

Introduction: Skin cancer can be divided in two types: melanoma or non-melanoma. Non-melanoma skin cancer is the most common type of cancer in humans.
The main primary prevention of skin cancer is photoprotection. The use of sunscreen acts to prevent the formation of actinic keratoses (precursor lesion of squamous cell carcinoma), squamous cell carcinoma itself and melanoma,1 which is still somewhat controversial in the latter case.
Secondary prevention occurs through early diagnosis and clinical and histopathological examination.

Materials / method: This is an observational, cross-sectional and descriptive epidemiological study, based on data obtained from the SUS Hospitalization System (SIH/SUS).

Results: Between 2016 and 2020, the year of 2019 had the highest absolute number of deaths from skin cancer in Brazil (574 deaths). Meanwhile, 2016 was the year which had the lowest absolute number (523 deaths).
At the same time, with respect to location, São Paulo was the state which had the highest number of deaths (640 deaths) as long as Acre was the one which had the lowest (2 deaths). In that regard, the southeast of Brazil was the region which had the highest number of deaths (1,215) and the northern, the lowest (88 deaths).

Conclusion: Even though primary and secondary prevention measures were established, the results found in this study allow us to conclude that skin cancer is still a disease that causes a lot of morbidity in Brazil.
In addition, the inequality observed in its control is notorious. During the same period, while some regions showed a reduction in the number of deaths, other regions remained with its increase, as observed in the southeast and southern region.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Clinical accuracy of non-melanoma skin cancer lesions in a dermatology referral hospital

Objectives: To analyze the accuracy of clinical suspicion of lesions suggestive of NMSC submitted to biopsy. Due to sun exposure in Brazil, NMSC have a high incidence in the country, justifying the need to acess the accuracy of clinical suspicion of these lesions.

Introduction: Skin cancer has acquired special importance in recent decades, due to its increasing incidence, being considered a public health problem in geographical areas of intense exposure to ultraviolet radiation. NMSC is represented by basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). BCC is responsible for 70% of skin cancer diagnoses, followed by SCC, diagnosed in 25% of cases.
The diagnosis of skin cancer involves clinical examination and histopathological analysis after biopsy of the lesion, which is indicated when, on clinical examination, there is suspicion of skin cancer.

Materials / method: This is a cross-sectional and retrospective observational study, through the analysis of medical records of patients who underwent skin biopsy due to suspicion of NMSC in a dermatology reference center, from June to December 2019.
The patients were grouped according to the anatomopathological result, forming three distinct groups: group 1, patients who confirmed neoplastic lesions in the anatomopathological analysis; group 2, patients who presented premalignant lesions in the anatomopathological result; group 3, patients who obtained benign lesions in the anatomopathological examination.

Results: 62% of the general sample confirmed neoplastic lesions in the anatomopathological analysis. 21% presented premalignant lesions and 17% presented benign lesions.
The samples from group 1 were subdivided according to the histological type of skin cancer: 163 cases of BCC (68% of group 1), 71 cases of SCC (30% of group 1) and 4 cases of other cancers (2% of group 1). In the latter group, the neoplasms found were: melanoma (1), undifferentiated carcinoma (1), epithelioid neoplasm (1) and adenocarcinoma (1).

Conclusion: Due to the epidemiological importance of the NMSC and considering its increasing incidence in the world population, its consideration as a public health problem is imperative. A greater understanding of clinical examination allows the implementation for an earlier diagnosis, reducing morbidity and mortality from this type of cancer.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Epidemiological analysis of non-melanoma skin cancer in a dermatology referral hospital

Objectives: This study aims to verify the epidemiological and clinical profile of patients undergoing skin biopsy for suspected non-melanoma skin cancer (NMSC) in a dermatology referral center, in Guarulhos, São Paulo, Brazil, from June to December 2019.

Introduction: Skin cancer has acquired special importance in recent decades, due to its increasing incidence, being considered a public health problem in geographical areas of intense exposure to ultraviolet radiation.NMSC is represented by basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). BCC is responsible for 70% of skin cancer diagnoses, followed by SCC, diagnosed in 25% of cases.

Materials / method: This is a cross-sectional and retrospective observational study, through the analysis of medical records of patients who underwent skin biopsy due to suspicion of NMSC in a dermatology reference center, from June to December 2019.
The patients were grouped according to the anatomopathological result, forming three distinct groups: group 1, patients who confirmed neoplastic lesions in the anatomopathological analysis; group 2, patients who presented premalignant lesions in the anatomopathological result; group 3, patients who obtained benign lesions in the anatomopathological examination.

Results: For this study, all skin biopsy samples indicated by clinical suspicion of NMSC were included, totaling 382 points of skin biopsies, in 287 patients, which corresponds to an average of 1.33 biopsies per patient, with a total number of maximum of 7 biopsies in the same patient.
In the overall sample, the age of the patients ranged between 20 and 97 years, with a median of 71 years. 126 patients were males (43.9%) and 161 were females (56.1%).

Conclusion: In this study, it was found a higher incidence of skin cancer in women, elderly patients and the most frequent diagnosis was BCC.
Due to the epidemiological importance of the NMSC and considering its increasing incidence in the world population, its consideration as a public health problem is imperative.
A greater understanding of the epidemiological profile of skin cancer in patients treated at a referral hospital allows a better assessment of the prevalence and possible risk factors associated with this type of neoplasm in this sample of population.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Body localization of non-melanoma skin cancer in a dermatology referral hospital

Objectives: This study aims to verify the clinical localization of non-melanoma skin cancer (NMSC) in a dermatology referral center, in Guarulhos, São Paulo, Brazil, from June to December 2019.

Introduction: Skin cancer can be divided in two types: melanoma or non-melanoma. Among NMSC, basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are the main ones.
NMSC is typically found in the cephalic, cervical, upper trunk and arms, which are the most photoexposed regions.

Materials / method: This is a cross-sectional and retrospective observational study, through the analysis of medical records of patients who underwent skin biopsy due to suspicion of NMSC in a dermatology reference center, from June to December 2019.
The patients were grouped according to the anatomopathological result, forming three distinct groups: group 1, patients who confirmed neoplastic lesions in the anatomopathological analysis; group 2, patients who presented premalignant lesions in the anatomopathological result; group 3, patients who obtained benign lesions in the anatomopathological examination.

Results: The most prevalent topographic location of all biopsies performed was cephalic segment was (58%), followed by the trunk and limbs (42%).
Analyzing each group individually, it was noticed that group 1 had 61% of the samples located in the cephalic segment. In group 2, the majority were also located in this body segment (53%). The same occurred in group 3: 54% of the biopsies occurred in the cephalic segment.
71% of the biopsy points for the BCC were performed in the cephalic segment; on the other hand, most of SCC biopsies were on the trunk and limbs (63%).

Conclusion: Recognizing the most frequent locations of NMSC allows the establishment of primary and secondary measures. In addition, these data collaborate to determine appropriate treatment plans for each location.
As shown, the most affected body areas are the sun-exposed regions, serving as substrate to reinforce the importance of photoprotection.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Effects of cross-linked HA fillers on metabolism, function and gene expression in human adipose tissue explants: ex vivo study (unrestricted educational grant from Fillmed Laboratoires)

Objectives: Previously, the same authors demonstrated the effect of the cross-linked HA fillers on the human primary cultured preadipocytes and mature adipocytes. The aim of this present study was to evaluate the preventing effects of cross-linked HA through an ex vivo model which is closer to the real condition.

Introduction: Age-dependent modifications of the facial subcutaneous white adipose tissue (sWAT) connected with reduction of its volume, modification of collagen content and adhesion between dermal and adipose layers can significantly cause the development of aging symptoms. Most therapeutic injectable options are targeted to the deep dermis and hypodermis to restore the age induced volume loss by filling the hollow zones. However, there is limited available data on the physiologic effects of these injectable products on the human adipocytes metabolism and function.

Materials / method: Human skin explants (3 layers) of 6 donors were prepared at D0 and different cross-Linked HA fillers or phosphate-buffer saline (PBS) solution (control) were injected into the immediate hypodermis by a 25G/ 55mm canula along the 2.5 cm long line. The explants were kept in survival between 8 and 15 days.The biochemical analyses on culture media were performed on lactate dehydrogenase (LDH), glycerol and adiponectin. Regarding gene expression, the expression of SIRT1, P53 and PPARγ2 was assessed. An automated quantification of the adipocytes surface was carried out on histological slides.

Results: All 3 HA fillers with different cross-linking level showed a protective effect on cytotoxicity with a progressive decrease of LDH level at D11, D13 and D15 compared to control. At D11, the glycerol level was diminished by 20% by the most cross-linked product and the adiponectin level was increased by 20% by a moderate cross-linked HA filler. For gene expression, SIRT1 as a PPARγ2inhibitor gene was decreased at D11 by the most cross-linked HA filler. On the other hand, P53 which induces cell apoptosis was diminished at D11 for all 3 variants. The PPARγ2 was augmented at D11 for all variants.

Conclusion: The diminution of P53 demonstrates that the cross-linked HA could prevent adipocyte apoptosis and the augmentation of PPARγ2 could promote the adipocyte differentiation and triglyceride storage which suggest the probable preventive effects of cross-linked HA fillers on human adipocytes aging process. The authors hypothesis proposes the preventive intra-fat pad multi-injections in young people to postpone the atrophic aging process of human adipocytes. This hypothesis should be supported by a cohort-controlled study. The future ex vivo studies should be designed with Human facial adipocytes.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

AbobotulinumtoxinA for the treatment of moderate-to-severe glabellar lines: a randomized, dose-escalating, double-blind study (unrestricted educational grant from Galderma)

Objectives: To evaluate the efficacy and safety of treatment of glabellar lines (GL) using abobotulinumtoxinA (50U, 75U, 100U or 125U) versus placebo, and the impact of dose escalation on duration of effect. The primary objective was to evaluate Month 1 composite investigator- and subject-assessed responder rate (≥2-grade improvement and glabellar line severity scale [GLSS] score 0 or 1) at maximum frown.

Introduction: AbobotulinumtoxinA (ABO) is a botulinum toxin type A for use in facial aesthetics
This study was performed to evaluate the efficacy and safety of a single dose of ABO (50 U, 75 U, 100 U or 125 U) versus placebo for treatment of moderate-to-severe glabellar lines (GL)

Materials / method: In this 9-month, dose-escalating, double-blind, Phase II study (NCT03736928), subjects received a single dose of abobotulinumtoxinA or placebo (randomized 4:1) for the treatment of moderate-to-severe GL. Assessments included investigator- and subject-assessed GLSS, time to onset, subject satisfaction, aesthetic improvement and adverse events.

Results: Each dose group included ~80 subjects. The primary objective was met; Month 1 composite ≥2-grade responder rate was 80% (50U), 89% (75U), 90% (100U), and 95% (125U) compared to 3% (placebo), p<0.001. Median time to onset was 2 days. Median time to return to baseline GLSS scores was 226, 240, 252, and 256 days. Month 9 responder rates of investigator-assessed ≥1-grade improvement were 18% (50U), 26% (75U), 35% (100U) and 31% (125U). Aesthetic improvement and subject satisfaction were high. Treatment-related adverse events were mainly mild, transient, and similar across doses.

Conclusion: AbobotulinumtoxinA was efficacious and well-tolerated across all doses, with rapid onset, duration up to 9 months and high subject satisfaction and aesthetic improvement.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Intermittent microalveolar stromal stimulation therapy: lower legs functional and cosmetic reshaping by lympho-venous network activation (unrestricted educational grant from icoone/I-Tech Industries Srl)

Objectives: The aim is to enhance the interstitial tissue compliance to get a biphasic mechanical activation, energetically spreading oxygen and micronutrients through the cell membrane barrier to subcellular organs (e.g. mitochondria and ribosomes) uptake and metabolism. The Multi Micro Alveolar Stimulation is very effective for remodelling almost every part of the body (arms, trunk, legs, face, neck, etc). The treatment benefits are not only instant post treatment, but they last for a certain period, because of the “memory” of elastic, collagenic and reticular fibres conditioned by this specific action

Introduction: The Multi Micro Alveolar Stimulation is provided by an electromedical device, icoone®, whose basic claim is to reactivate the mesenchymal tissue either in superficial or deep subcutaneous but also pre- and post-fascial layers by stimulating the elastic fibers, the fat cells and the microalveolar spaces.

Materials / method: Twenty‑five female patients were recruited in this study. icoone® device was used for its unique action on the skin and subcutaneous tissues. The circumferences of foot, ankle and leg were measured before starting the treatment, after 1 month of treatment, and 1 month after the interruption. In addition, skin parameters (elasticity and dermis embedding/water retention) were analysed before and at the end of the treatment. Finally, a self-reported questionnaire was administered in order to assess the benefits of icoone® treatment.

Results: A significant reduction of foot, ankle and leg circumference was observed after 1 month (P=0.019; P=0.001; P=0.002 respectively). A significant correlation was present between the BMI and leg circumference measured before starting the treatment (P=0.002). A significant increase of skin elasticity (P=0.01) and reduction of skin dermis embedding/water retention (P=0.001) were registered after 1 month. Patients reported subjective legs lightness feelings, enhanced micturition, sparkling energy and wellbeing after each session. A more appealing aesthetic outcome was also registered.

Conclusion: There is evidence that the treatment with icoone® is effective in lower legs health, both from an aesthetic and a functional point of view, maintaining the results especially if periodically repeated.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

High-risk actinic cheilitis treated with fractionated ablative carbon dioxide laser in combination with TCA 30% peel and topical tretinoin 0.05% cream

Objectives: 1. To present a case of actinic cheilitis and its rarity
2. To briefly review the possible etiologies, clinical presentation, histopathologic findings and treatment
3. To evaluate the efficacy of carbon dioxide laser combined with trichloroacetic peel and tretinoin in the treatment of actinic cheilitis

Introduction: Actinic Cheilitis (AC) is a premalignant disease associated with chronic sun exposure that may develop squamous cell carcinoma of the lip. Its manifestations vary from being asymptomatic to pain and swelling of the lips and the development of scaly crust on the vermilion commonly seen in the lower lip.

Materials / method: We present a case of 50-year old female presenting with painful fissured plaques of both upper and lower lip. Biopsy results were consistent with high-risk AC. The patient was treated with fractionated ablative carbon dioxide (CO2) laser in combination with trichloroacetic acid (TCA) 30% peel and topical tretinoin 0.05% cream.

Results: The patient was treated with fractionated ablative CO2 laser using the following settings: ultrapulse mode, E=30 mJ, pulse duration = 400 mcs and repeat time= 200ms. Thereafter, TCA 30% peel was applied. Three days post-op showed hyperpigmented crusts with some fissuring. We prescribed tretinoin 0.05% cream at night and emphasized sun protection. One month postop, the patient reported decrease in pain and pruritus. There is also noted decrease in fissures on affected areas. A second session of CO2 laser and TCA 30% peel was done two months after the first session.

Conclusion: In conclusion, AC is a premalignant condition that should be treated promptly. Non-surgical treatments are preferred for lesser chance of adverse effects and convenience. Combination treatment of non-surgical options might work better synergistically than given alone.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

A randomized, placebo-controlled study of AbobotulinumtoxinA for treatment of glabellar lines using a new dilution and injection volume (unrestricted educational grant from Galderma)

Objectives: The purpose of this study was to evaluate a new dilution and injection volume of AbobotulinumtoxinA (ABO) for treatment of moderate to severe glabellar lines (GL). Primary objective was the efficacy of a single dose of 50 U of ABO, using 0.1 mL in each injection point, compared to placebo. For the primary endpoint at Month 1, a composite responder had a score of 0 or 1 in GL severity at maximum frown and ≥2-grade improvement from baseline on both of the 4-point glabellar line severity scales ILA (investigator’s live assessment) and SSA (subject’s self-assessment).

Introduction: According to current US label for ABO, a total of 50 U is injected intramuscularly in aliquots of 0.05 mL into each of five injection points in the glabellar area; 2 in each corrugator muscle and 1 in the procerus muscle. It is proposed that a larger volume for dilution and injection to deliver 50 U of ABO has similar efficacy and safety, and that it also provides more options for aesthetic health care professionals in their clinical practise.

Materials / method: In this double-blind, 6-month study, subjects aged 18-65 with no Botulinum toxin treatment in the face within 6 months prior to study treatment, were randomized 3:1 to ABO (N=224) or placebo (N=77) across 12 sites in the US. A 300 U vial was reconstituted with 3.0 mL 0.9% NaCl, and 0.5 mL (50 U) was injected as a single treatment in the 5 sites of the glabellar area (0.1 mL per site), using a 30G needle. Assessments included ILA/SSA evaluations, subject satisfaction, time to onset of treatment response, aesthetic improvement and safety.

Results: Mean age for all subjects was 44.1 years, and the majority (88%) were female. The primary efficacy objective was met with an ABO composite responder rate of 65.8% at Month 1. Median time to onset was 2 days. Subjects with an ILA score of 0 or 1 were significantly higher for ABO than placebo through Month 6. Median time to loss of a score of 0 or 1 on ILA and SSA concurrently at maximum frown was 163 days for ABO. A majority of subjects in the ABO group reported aesthetic improvement 6 months after treatment, and subject satisfaction was high. The treatment was well-tolerated.

Conclusion: This study demonstrated high efficacy and well-tolerated safety profile with fast onset and long duration of effect of an injection volume of 0.1 mL (10 U ABO) per injection site for treatment of moderate to severe glabellar lines. Aesthetic improvement and subject satisfaction was high and lasted through 6 months.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Millennial subject satisfaction with two treatments of AbobotulinumtoxinA a year (unrestricted educational grant from Galderma)

Objectives: Millennials are increasingly becoming a larger part of the aesthetic market. However, expectations are high, particularly with their first aesthetic treatment, which data shows is likely to be botulinum toxins. They also represent a subset which may not be as open to frequent aesthetic treatments.

Introduction: Millennials are increasingly becoming a larger percentage of the aesthetic market.
However, expectations are high, particularly with their first aesthetic treatment, which data shows is likely to be botulinum toxins.
They also represent a subset of the market which, due to financial constraints, may not be open to coming in as frequently for aesthetic treatments.

Materials / method: A post-hoc analysis compared subject satisfaction by age in a 12-month, open-label, multicenter study (NCT03687736) of two glabellar line injections of 50U AbobotulinumtoxinA (at baseline and 6 months). Age groups were segmented by decade, from 20-61+ years old, with millennials defined as age 21-40. Subject satisfaction and subject-reported FACE-Q were evaluated 6 months after each treatment.

Results: While overall satisfaction rate was high across all age groups (≥86%), a higher proportion of millennials was highly satisfied (21-40: 75%; 50-60+: 49%). Millennials were happier with their glabellar lines at baseline, but all age groups reported large improvements 6 months after second treatment (mean Rasch score increase: 10.1-28.2). The youngest and oldest groups had larger improvements in psychological wellness (mean Rasch score increase 6 months after each treatment: 21-30: 4.1-8.9, >60: 8.6-15.7). At study end, 100% of millennials stated they would like to receive the treatment again.

Conclusion: While all age groups were satisfied with and experienced psychological benefits from treatment, millennials appeared to be particularly happy with two treatments a year of abobotulinumtoxinA.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): Galderma

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): Galderma

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo es presentado gracias al apoyo de: Galderma

Subject satisfaction with two treatments a year (every six months) of AbobotulinumtoxinA is high among both previously treated and toxin-naive cohorts (unrestricted educational grant from Galderma)

Objectives: Patients who have previous experience with and those naïve to aesthetic botulinum toxin treatments may have different expectations, leading to differences in satisfaction. Furthermore, some have suggested onset and duration of effect may differ. Therefore, a post-hoc analysis of a study of twice-yearly treatment with abobotulinumtoxinA was done to compare outcome by prior treatment experience.

Introduction: Patients who have previous experience with and those naïve to toxin treatment may have different expectations when being treated with botulinum toxins, leading to differences in satisfaction.
Some studies have suggested onset and duration of effect may differ1
Therefore, we completed a post-hoc analysis looking at subject satisfaction and efficacy between subjects naïve to treatment from a recent study that looked at satisfaction with two treatments of AbobotulinumtoxinA (ABO) a year

Materials / method: A post-hoc analysis of toxin-naïve subjects vs. previously treated was performed of an open-label, multicenter study evaluating subject satisfaction after glabellar line (GL) injections of 50U abobotulinumtoxinA at baseline and re-treatment at 6 months (NCT03687736). Follow-up at Month 1, 3, 6, 7, 9, and 12 assessed subject satisfaction, subject-reported FACE-Q, and GL severity score (GLSS).

Results: Subject satisfaction rates were high at Month 12 for both previously treated (93%) and toxin-naïve (97%) , though toxin-naïve subjects were more likely to be highly satisfied (66% vs. 57%). Moreover, toxin-naïve subjects reported feeling better about themselves, more satisfaction with their appearance, and feeling more attractive 6 months after each treatment. Previously treated subjects reported earlier onset of effect (24 hours: 35-37% vs. 14-24% toxin-naive). Subject-assessed GLSS responder rates were higher for toxin-naïve, while investigators found higher rates in previously treated.

Conclusion: Subject satisfaction with two treatments a year (every 6 months) was high, whether they had experience with previous toxin treatments or not. Clinical efficacy did not appear to differ, though toxin-naïve subjects were more likely to report high overall satisfaction.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

A study of combined microfocused ultrasound and hyaluronic acid dermal filler in the treatment of enlarged facial pores in Asians

Objectives: To compare the efficacy of MFU-V monotherapy and MFU-V combined with L-HA injection for the treatment of enlarged facial pores in Asians.

Introduction: Enlarged facial pores are a common cosmetic complaint among people around the world. Microfocused ultrasound with visualization (MFU-V) has been shown to improve the appearance of facial pores. Low-degree cross-linked hyaluronic acid filler (L-HA) injection has recently become a popular procedure for skin rejuvenation. Nevertheless, the effectiveness of the combination of MFU-V and L-HA injection in the treatment of enlarged pores has not been evaluated.

Materials / method: We conducted a randomized, single-blinded, split-face study on participants with enlarged facial pores. Each side of the face was randomly assigned to treatment with a single session of MFU-V or combined MFU-V with L-HA injection. Pore volume was objectively measured by an Antera 3D system. Subjective assessment was evaluated by one-blinded physician using a pore grading score (0-4). Patients also rated the improvement in terms of satisfaction using the visual analog scale (VAS, 0-10).

Results: Forty-six subjects completed the study. The mean pore volume of both sides declined with statistical significance at every visit compared to baseline, with the lowest mean at 4 months posttreatment. The combined MFU-V with L-HA injection showed a lower mean pore volume than MFU-V monotherapy throughout the study. According to physicians' evaluation, there was no statistically significant difference between the two techniques. The patient satisfaction score showed a similar trend to the mean pore volume, with a statistically difference at 4 and 6 months posttreatment.

Conclusion: MFU-V monotherapy and MFU-V combined with L-HA injection can effectively and safely minimize enlarged facial pores. The combined technique resulted in more patient satisfaction.

Declaraciones

¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No

¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No

¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No

¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No

Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.

Oradores	Título de la presentación	Resumen	Número
Dr Sue Ellen COX	Subject-relevant outcomes of on-label 50U AbobotulinumtoxinA treatment for moderate-to-severe glabellar lines across three individual studies (unrestricted educational grant from Galderma)	Ver	111998
Dr Steven H DAYAN	Subject satisfaction with AbobotulinumtoxinA for moderate-to-severe glabellar lines: a randomized, dose-escalating, double-blind study (unrestricted educational grant from Galderma)	Ver	111999
Dr Mariana DULTRA	Epidemiological analysis of the number of deaths by skin cancer, between 2016 and 2020 in Brazil	Ver	111890
Dr Mariana DULTRA	Clinical accuracy of non-melanoma skin cancer lesions in a dermatology referral hospital	Ver	111892
Dr Mariana DULTRA	Epidemiological analysis of non-melanoma skin cancer in a dermatology referral hospital	Ver	111893
Dr Mariana DULTRA	Body localization of non-melanoma skin cancer in a dermatology referral hospital	Ver	111894
Dr Ferial FANIAN	Effects of cross-linked HA fillers on metabolism, function and gene expression in human adipose tissue explants: ex vivo study (unrestricted educational grant from Fillmed Laboratoires)	Ver	111932
Dr John H JOSEPH	AbobotulinumtoxinA for the treatment of moderate-to-severe glabellar lines: a randomized, dose-escalating, double-blind study (unrestricted educational grant from Galderma)	Ver	112001
Prof Beniamino PALMIERI	Intermittent microalveolar stromal stimulation therapy: lower legs functional and cosmetic reshaping by lympho-venous network activation (unrestricted educational grant from icoone/I-Tech Industries Srl)	Ver	112114
Dr Ivan Arni C PRECLARO	High-risk actinic cheilitis treated with fractionated ablative carbon dioxide laser in combination with TCA 30% peel and topical tretinoin 0.05% cream	Ver	99260
Dr Joel SCHLESSINGER	A randomized, placebo-controlled study of AbobotulinumtoxinA for treatment of glabellar lines using a new dilution and injection volume (unrestricted educational grant from Galderma)	Ver	112000
Dr Joel SCHLESSINGER	Millennial subject satisfaction with two treatments of AbobotulinumtoxinA a year (unrestricted educational grant from Galderma)	Ver	112087
Dr Ava SHAMBAN	Subject satisfaction with two treatments a year (every six months) of AbobotulinumtoxinA is high among both previously treated and toxin-naive cohorts (unrestricted educational grant from Galderma)	Ver	112088
Dr Vasanop VACHIRAMON	A study of combined microfocused ultrasound and hyaluronic acid dermal filler in the treatment of enlarged facial pores in Asians	Ver	111766

IMCAS Asia 2021
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IMCAS Asia 2021 Programa

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IMCAS Asia 2021
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