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This case series evaluated use of injectable platelet rich fibrin (termed i-PRF+) for the treatment of female pattern hair loss (FPHL). Eleven individuals underwent 3-monthly intradermal injections of i-PRF+ using a mesotherapy gun. The mean number of hair follicles containing hairs per unit area improved at 3- and 6-months follow-up (p < .001), and all participants had a negative hair pull test. Hair volume and thickness, and patient-reported outcome scores also improved at follow-up (p < .001). Adverse effects were minor and self-limited. A series of three i-PRF+ injection sessions were effective for the treatment of FPHL, as shown by improved hair analysis parameters and patient self-assessment scores.
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Alopecia , Fibrina Rica en Plaquetas , Humanos , Femenino , Alopecia/terapia , Alopecia/tratamiento farmacológico , Adulto , Persona de Mediana Edad , Inyecciones Intradérmicas , Técnicas Cosméticas , Folículo Piloso , Satisfacción del PacienteRESUMEN
BACKGROUND: Skin incision scars are cosmetically displeasing; the effects of current treatments are limited, and new methods to reduce scar formation need to be found. OBJECTIVE: We sought to determine whether immediate postoperative injection of stromal vascular fraction gel (SVF-gel) could reduce scar formation at skin incision sites. METHODS: A prospective, randomized, double-blind, self-controlled trial was conducted in patients who underwent breast reduction. SVF-gel was intradermally injected into the surgical incision on one randomly selected side, with the other side receiving saline as a control. At the 6-month follow-up, the incision scars were evaluated using the Vancouver scar scale (VSS) and visual analog scale (VAS). Antera 3D camera was used for objective evaluation. RESULTS: The VSS score and VAS score were significantly different between the SVF-gel-treated side (3.80 ± 1.37, 3.37±1.25) and the control side (5.25 ± 1.18, 4.94 ± 1.28). Moreover, the SVF-gel-treated side showed statistically significant improvements in scar appearance, based on evidences from Antera 3D camera. LIMITATIONS: This was a single-center, single-race, and single-gender study. Furthermore, the results were available only for the 6-month interim follow-up period. CONCLUSION: Postoperative immediate SVF-gel injection in surgical incisions can reduce scar formation, and exert a preventive effect on scars. LEVEL OF EVIDENCE I: Evidence obtained from at least one properly designed randomized controlled trial. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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Cicatriz , Geles , Mamoplastia , Humanos , Método Doble Ciego , Cicatriz/prevención & control , Cicatriz/etiología , Femenino , Estudios Prospectivos , Adulto , Mamoplastia/métodos , Resultado del Tratamiento , Persona de Mediana Edad , Inyecciones Intradérmicas , Factores de Tiempo , Estudios de Seguimiento , Estética , Cicatrización de Heridas/fisiologíaRESUMEN
BACKGROUND: Dark eye circle (DEC) is one of the most common cosmetic problems. It has a great impact on the patients' quality of life. Carboxytherapy is a cosmetic technique using pure carbon dioxide for different uses in different areas of the body. The goal of this study is to evaluate the efficacy and tolerability of carboxytherapy in the cosmetic correction of DECs. METHODS: This study was conducted on 27 patients requesting the correction of DEC. The treatment was performed using a carboxy device in medical grade. The gas injection was performed intradermal after local anesthesia, with a pressure of one tenth bar and a speed of 20 cc/min, 1 cc in each upper and lower eyelid. The treatment sessions were done every 2 weeks for four sessions. RESULTS: The mean physicians' score of DECs before and after treatment was 8.7 ± 0.81 and 4.6 ± 1.1, respectively. The mean patients' score before and after treatment was 9.2 ± 0.5 versus 5.41 ± 1.37. The mean scores showed a significant reduction of skin discoloration without major side effects (p < 0.00001). CONCLUSION: Carboxytherapy seems to be an effective treatment option for dark circles around the eyes with a good safety profile and patient satisfaction.
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Dióxido de Carbono , Técnicas Cosméticas , Satisfacción del Paciente , Humanos , Femenino , Adulto , Masculino , Dióxido de Carbono/administración & dosificación , Resultado del Tratamiento , Persona de Mediana Edad , Párpados/efectos de los fármacos , Adulto Joven , Inyecciones Intradérmicas , Hiperpigmentación/tratamiento farmacológicoRESUMEN
OBJECTIVE: To compare the effectiveness of intense pulsed light (IPL) and intradermal tranexamic acid (TXA) in treating melasma. STUDY DESIGN: A cross-sectional analytical study. Place and Duration of the Study: Department of Dermatology, Dow International Medical College, Dow University Hospital, Karachi, Pakistan, from 15th January to 15th July 2023. METHODOLOGY: A total of 62 patients with melasma, aged 20-50 years, were divided into two groups. Group A (32 patients) received IPL (560 nm filter was used) treatment, and Group B (30 patients) received intradermal TXA. Each group underwent four treatment sessions with varying intervals. Melasma area and severity index (MASI) scores were used to compare the effects of treatment. RESULTS: After a 3-month treatment period, both groups showed reduced mMASI scores compared to baseline with a significant initial difference between Group A (8.6 ± 4.2) and Group B (5.4 ± 2.7, p <0.001). However, post-treatment, there was no significant difference in mMASI scores (Group A: 3.8 ± 2.6; Group B: 3.2 ± 2.0, p = 0.29). IPL treatment (Group A) demonstrated a significant reduction in mMASI scores (57.1 ± 19.7) compared to intradermal TXA treatment (Group B, 42.2 ± 18.8, p = 0.0034). CONCLUSION: Both IPL and intradermal TXA treatments effectively reduced melasma, with IPL exhibiting superior results. However, post-treatment outcomes converged, emphasising the need for personalised approaches considering the unique characteristics of South East Asian skin. KEY WORDS: Intense pulsed light, Melasma, Intradermal tranexamic acid.
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Tratamiento de Luz Pulsada Intensa , Melanosis , Ácido Tranexámico , Humanos , Ácido Tranexámico/administración & dosificación , Ácido Tranexámico/uso terapéutico , Melanosis/terapia , Melanosis/tratamiento farmacológico , Adulto , Femenino , Estudios Transversales , Persona de Mediana Edad , Resultado del Tratamiento , Masculino , Tratamiento de Luz Pulsada Intensa/métodos , Inyecciones Intradérmicas , Pakistán , Antifibrinolíticos/administración & dosificación , Antifibrinolíticos/uso terapéutico , Adulto Joven , Índice de Severidad de la EnfermedadRESUMEN
The incidence of rabies in Thailand reached its peak in 2018 with 18 human deaths. Preexposure prophylaxis (PrEP) vaccination is thus recommended for high-risk populations. WHO has recently recommended that patients who are exposed to a suspected rabid animal and have already been immunized against rabies should receive a 1-site intradermal (ID) injection of 0.1 mL on days 0 and 3 as postexposure prophylaxis (PEP). In Thailand, village health and livestock volunteers tasked with annual dog vaccination typically receive only a single lifetime PrEP dose and subsequent boosters solely upon confirmed animal bites. However, the adequacy of a single PrEP dose for priming and maintaining immunity in this high-risk group has not been evaluated. Therefore, our study was designed to address two key questions: (1) sufficiency of single-dose PrEP-to determine whether a single ID PrEP dose provides adequate long-term immune protection for high-risk individuals exposed to numerous dogs during their vaccination duties. (2) Booster efficacy for immune maturation-to investigate whether one or two additional ID booster doses effectively stimulate a mature and sustained antibody response in this population. The level and persistence of the rabies antibody were determined by comparing the immunogenicity and booster efficacy among the vaccination groups. Our study demonstrated that rabies antibodies persisted for more than 180 days after cost-effective ID PrEP or the 1st or the 2nd single ID booster dose, and adequate antibody levels were detected in more than 95% of participants by CEE-cELISA and 100% by indirect ELISA. Moreover, the avidity maturation of rabies-specific antibodies occurred after the 1st single ID booster dose. This smaller ID booster regimen was sufficient for producing a sufficient immune response and enhancing the maturation of anti-rabies antibodies. This safe and effective PrEP regimen and a single visit involving a one-dose ID booster are recommended, and at least one one-dose ID booster regimen could be equitably implemented in at-risk people in Thailand and other developing countries. However, an adequate antibody level should be monitored before the booster is administered.
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Anticuerpos Antivirales , Inmunización Secundaria , Vacunas Antirrábicas , Rabia , Vacunas Antirrábicas/inmunología , Vacunas Antirrábicas/administración & dosificación , Rabia/prevención & control , Rabia/inmunología , Anticuerpos Antivirales/sangre , Tailandia , Humanos , Inyecciones Intradérmicas , Animales , Femenino , Adulto , Masculino , Adulto Joven , Afinidad de Anticuerpos , Persona de Mediana Edad , Perros , Profilaxis Pre-Exposición/métodos , Adolescente , Profilaxis Posexposición/métodos , Formación de Anticuerpos/inmunologíaRESUMEN
BACKGROUND: The aim of this study is to investigate the impact of the intradermal injection of purified protein derivative (PPD) and PPD skin test reactions on the oncological outcomes of patients with non-muscle invasive bladder cancer (NMIBC) treated by trans-urethral resection of bladder tumor (TURBT) and adjuvant intravesical BCG. METHODS: The study included 100 consecutive patients with NMIBC prospectively given intradermal PPD 1-2 weeks before starting BCG therapy. Another 100 patients with NMIBC not given intradermal PPD before starting BCG were chosen as a historical control. The control group was chosen to be matching with the study group regarding baseline characteristics. The study group was divided into 2 subgroups with positive and negative reaction to PPD skin test. Oncological outcomes, immunological markers (TNF-α and IL-6) changes and BCG side effects were evaluated. RESULTS: There were no significant differences between patients who received PPD or not regarding the 2-year recurrence free survival (RFS) rates and progression-free survival (PFS) rates and immunological markers changes. The 2-year RFS and PFS rates were significantly higher in patients with positive reactions. Post-induction values of immunological markers increased in all patients with a significant increase in patients with positive reactions. BCG side effects were significantly higher in patients with positive reactions. CONCLUSIONS: The intradermal injection of PPD before intravesical BCG has no impact on oncological outcomes of patients with NMIBC treated with TURBT and intravesical BCG. However, the PPD skin test reactions before BCG therapy can predict the oncological outcomes, BCG side effects and the immunological outcomes of patients.
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Vacuna BCG , Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/inmunología , Neoplasias de la Vejiga Urinaria/patología , Vacuna BCG/uso terapéutico , Vacuna BCG/administración & dosificación , Vacuna BCG/inmunología , Masculino , Femenino , Administración Intravesical , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Adyuvantes Inmunológicos/administración & dosificación , Adyuvantes Inmunológicos/uso terapéutico , Adyuvantes Inmunológicos/farmacología , Adyuvantes Inmunológicos/efectos adversos , Invasividad Neoplásica , Tuberculina/inmunología , Tuberculina/administración & dosificación , Inyecciones Intradérmicas , Resultado del Tratamiento , Neoplasias Vesicales sin Invasión MuscularRESUMEN
In May 2022, mpox began to spread worldwide, posing a serious threat to human public health. Modified Vaccinia Ankara-Bavaria Nordic (MVA-BN) is a live attenuated orthopoxvirus vaccine that has been authorized by the U.S. Food and Drug Administration as the vaccine of choice for the prevention of mpox. In this study, we conducted a meta-analysis of all currently published literature on the efficacy and safety of the MVA-BN vaccine in the real world, showing that the MVA-BN vaccine is effective and safe, with efficacy of up to 75% with a single dose and up to 80% with a two-dose vaccine. Meanwhile, we found that subcutaneous injection has lower local and systemic adverse events than intradermal injection, regardless of single- or two-dose vaccination, and subcutaneous injection is better tolerated in children, the elderly, or people with underlying medical conditions. These results have important reference value for clinical practice.
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Eficacia de las Vacunas , Vacunas Atenuadas , Humanos , Vacunas Atenuadas/inmunología , Vacunas Atenuadas/administración & dosificación , Vacunas Atenuadas/efectos adversos , Infecciones por Poxviridae/prevención & control , Infecciones por Poxviridae/inmunología , Virus Vaccinia/inmunología , Virus Vaccinia/genética , Vacunación , Inyecciones Subcutáneas , Inyecciones Intradérmicas , Vacunas Virales/efectos adversos , Vacunas Virales/inmunología , Vacunas Virales/administración & dosificación , Orthopoxvirus/inmunología , Orthopoxvirus/genética , NiñoRESUMEN
The objective of this study was to investigate if delivering multiple doses of N-acetylcysteine (NAC) post-surgery in addition to pre-incisional administration significantly impacts the wound healing process in a rat model. Full-thickness skin incisions were carried out on the dorsum of 24 Sprague-Dawley rats in six locations. Fifteen minutes prior to the incision, half of the sites were treated with a control solution, with the wounds on the contralateral side treated with solutions containing 0.015%, 0.03% and 0.045% of NAC. In the case of the NAC treated group, further injections were given every 8 h for three days. On days 3, 7, 14 and 60 post-op, rats were sacrificed to gather material for the histological analysis, which included histomorphometry, collagen fiber organization analysis, immunohistochemistry and Abramov scale scoring. It was determined that scars treated with 0.015% NAC had significantly lower reepithelization than the control at day 60 post-op (p = 0.0018). Scars treated with 0.045% NAC had a significantly lower collagen fiber variance compared to 0.015% NAC at day 14 post-op (p = 0.02 and p = 0.04) and a lower mean scar width than the control at day 60 post-op (p = 0.0354 and p = 0.0224). No significant differences in the recruitment of immune cells and histological parameters were found. The results point to a limited efficacy of multiple NAC injections post-surgery in wound healing.
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Acetilcisteína , Ratas Sprague-Dawley , Cicatrización de Heridas , Animales , Cicatrización de Heridas/efectos de los fármacos , Acetilcisteína/farmacología , Acetilcisteína/administración & dosificación , Ratas , Inyecciones Intradérmicas , Modelos Animales de Enfermedad , Piel/efectos de los fármacos , Piel/patología , Piel/lesiones , Masculino , Herida Quirúrgica/tratamiento farmacológico , Herida Quirúrgica/patología , Colágeno/metabolismo , Cicatriz/patología , Cicatriz/tratamiento farmacológicoRESUMEN
INTRODUCTION: Stump hyperhidrosis is a common condition after lower limb amputation. It affects the prosthesis use, and the quality of life of patients. Several case reports tried to prove benefit of using Botulinum toxin in its treatment. AIM: This study was to conduct a larger workforce clinical trial and to demonstrate benefits of botulinum toxin injection in the treatment of stump hyperhidrosis. METHODS: A prospective study was conducted. War amputees who complained of annoying excessive sweating of the stump were included. They received intradermal injection of botulinum toxin A in the residual limb area in contact with prosthetic socket. Abundance of sweating and degree of functional discomfort associated with it were assessed before, after 3 weeks, 6 and 12 months. RESULTS: Seventeen male patients, followed for post-traumatic limb amputation were included in the study. Discomfort and bothersome in relation to Hyperhidrosis did decrease after treatment (p<0,001). Reported satisfaction after 3 weeks was 73,33%. Improvement of prothesis loosening up after 3 weeks was 72,5% [±15,6]. Mean injection-induced pain on the visual analogue scale was 5.17/10 (±1.58). The mean interval after the onset of improvement was 5.13 days [min:3, max:8]. The mean time of improvement was 10.4 months after the injection [min:6, max:12]. No major adverse events were reported following treatment. CONCLUSION: Intradermal injections of botulinum toxin in the symptomatic treatment of stump hyperhidrosis are effective and have few adverse effects. It improves the quality of life of our patients thanks to a better tolerance of the prosthesis.
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Muñones de Amputación , Amputados , Toxinas Botulínicas Tipo A , Hiperhidrosis , Humanos , Hiperhidrosis/tratamiento farmacológico , Masculino , Adulto , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/efectos adversos , Estudios Prospectivos , Miembros Artificiales/efectos adversos , Inyecciones Intradérmicas , Persona de Mediana Edad , Guerra , Calidad de Vida , Adulto Joven , Resultado del TratamientoRESUMEN
BACKGROUND: Skin 16S microbiome diversity analysis indicates that the Staphylococcus genus, especially Staphylococcus aureus (S. aureus), plays a crucial role in the inflammatory lesions of acne. However, current animal models for acne do not fully replicate human diseases, especially pustular acne, which limits the development of anti-acne medications. AIMS: The aim is to develop a mouse model for acne, establishing an animal model that more closely mimics the clinical presentation of pustular acne. This will provide a new research platform for screening anti-acne drugs and evaluating the efficacy of clinical anti-acne experimental treatments. METHODS: Building upon the existing combination of acne-associated Cutibacterium acnes (C. acnes) with artificial sebum, we will inject a mixture of S. aureus and C. acnes locally into the dermis in a 3:7 ratio. RESULTS: We found that the acne animal model with mixed bacterial infection better replicates the dynamic evolution process of human pustular acne. Compared to the infection with C. acnes alone, mixed bacterial infection resulted in pustules with a distinct yellowish appearance, resembling pustular acne morphology. The lesions exhibited redness, vascular dilation, and noticeable congestion, along with evident infiltration of inflammatory cells. This induced higher levels of inflammation, as indicated by a significant increase in the secretion of inflammatory factors such as IL-1ß and TNF-α. CONCLUSION: This model can reflect the clinical symptoms and development of human pustular acne, overcoming the limitations of animal models commonly used in basic research to study this situation. It provides support for foundational research and the development of new acne medications.
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Acné Vulgar , Modelos Animales de Enfermedad , Acné Vulgar/microbiología , Acné Vulgar/patología , Animales , Ratones , Inyecciones Intradérmicas , Staphylococcus aureus/aislamiento & purificación , Propionibacterium acnes/aislamiento & purificación , Humanos , Piel/microbiología , Piel/patología , Propionibacteriaceae/aislamiento & purificaciónRESUMEN
INTRODUCTION: Naked DNA vaccination could be a powerful and safe strategy to mount antigen-specific cellular immunity. We designed a phase I clinical trial to investigate the toxicity of naked DNA vaccines encoding CD8+ T-cell epitope from tumor-associated antigen MART-1 in patients with advanced melanoma. METHODS: This dose escalating phase Ia clinical trial investigates the toxicity and immunological response upon naked DNA vaccines encoding a CD8+ T-cell epitope from the tumor-associated antigen MART-1, genetically linked to the gene encoding domain 1 of subunit-tetanus toxin fragment C in patients with advanced melanoma (inoperable stage IIIC-IV, AJCC 7th edition). The vaccine was administrated via intradermal application using a permanent make-up or tattoo device. Safety was monitored according to CTCAE v.3.0 and skin biopsies and blood samples were obtained for immunologic monitoring. RESULTS: Nine pretreated, HLA-A*0201-positive patients with advanced melanoma expressing MART-1 and MHC class I, with a good performance status, and adequate organ function, were included. With a median follow-up of 5.9 months, DNA vaccination was safe, without treatment-related deaths. Common treatment-emergent adverse events of any grade were dermatologic reactions at the vaccination site (100%) and pain (56%). One patient experienced grade 4 toxicity, most likely related to tumor progression. One patient (11%) achieved stable disease, lasting 353 days. Immune analysis showed no increase in vaccine-induced T cell response in peripheral blood of 5 patients, but did show a MART-1 specific CD8+ T cell response at the tattoo administration site. The maximum dose administered was 2 mg due to lack of clinical activity. CONCLUSION: We showed that the developed DNA vaccine, applied using a novel intradermal application strategy, can be administered safely. Further research with improved vaccine formats is required to show possible clinical benefit of DNA vaccination.
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Vacunas contra el Cáncer , Melanoma , Estadificación de Neoplasias , Tatuaje , Vacunas de ADN , Humanos , Melanoma/inmunología , Melanoma/terapia , Vacunas de ADN/administración & dosificación , Vacunas de ADN/inmunología , Persona de Mediana Edad , Femenino , Masculino , Vacunas contra el Cáncer/administración & dosificación , Vacunas contra el Cáncer/inmunología , Vacunas contra el Cáncer/uso terapéutico , Inyecciones Intradérmicas , Anciano , Adulto , Neoplasias Cutáneas/inmunología , Antígeno MART-1/inmunología , Linfocitos T CD8-positivos/inmunología , Vacunación/métodos , Resultado del Tratamiento , Antígeno HLA-A2/inmunología , Epítopos de Linfocito T/inmunologíaRESUMEN
The Royal Prince Alfred Hospital Mpox Vaccination Clinic opened in response to the 2022 multicountry mpox outbreak. A total of 9500 vaccinations were administered intradermally and subcutaneously during the first 16 weeks of clinic operation. The rate of adverse events was 0.1%. Compared to people who received the vaccine intradermally, those who received it subcutaneously were more likely to be aged 30-39 years (P = 0.047), sexual partners of gay and bisexual men (P < 0.001), eligible for Medicare (P < 0.001) and born in the Philippines (P = 0.01) or Malaysia (P = 0.04).
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Vacunación Masiva , Mpox , Vacuna contra Viruela , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Australia/epidemiología , Inyecciones Intradérmicas , Inyecciones Subcutáneas/efectos adversos , Prevalencia , Vacuna contra Viruela/administración & dosificación , Mpox/prevención & controlRESUMEN
BACKGROUND: A laser-induced needle-free microjet injector was developed for rapid, high-speed drug delivery of microliters into the skin. OBJECTIVE: This study evaluated the clinical rejuvenation effect of repeated dermal injections of the collagen simulator poly- dl -lactic acid (PDLA) using a laser-induced needle-free microjet injector. METHODS: Five PDLA injection sessions using a laser-induced needle-free microjet injector were conducted in patients concerned about aging skin. Facial uplifting, darkness, redness, roughness, pore size, subjective satisfaction, and side effects were evaluated before each session and 4 weeks after treatment completion. Histological evaluation was also performed with immunohistochemical staining of collagen and elastic fibers. RESULTS: The clinical results of 27 female patients were evaluated. The treatment resulted in a noticeable skin surface uplifting (0.711 ± 0.42 mm) and significant improvements in darkness ( p = .013), redness ( p = .009), and roughness ( p = .036), with no significant difference in the pore size ( p = .770). Patients were reported being satisfied with the overall therapeutic effects, despite mild and tolerable adverse effects. Histological findings revealed growth and thickening of collagen and elastic fibers, with marked increase in collagen I and III levels. CONCLUSION: Repeated dermal injections of PDLA using a laser-induced microjet injector offer excellent drug delivery, achieving high efficacy in skin rejuvenation, patient satisfaction, and safety.
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Técnicas Cosméticas , Satisfacción del Paciente , Poliésteres , Rejuvenecimiento , Envejecimiento de la Piel , Humanos , Femenino , Envejecimiento de la Piel/efectos de los fármacos , Poliésteres/administración & dosificación , Persona de Mediana Edad , Técnicas Cosméticas/instrumentación , Adulto , Cara , Anciano , Polímeros/administración & dosificación , Inyecciones Intradérmicas/instrumentación , Ácido Láctico/administración & dosificación , Rayos Láser , Rellenos Dérmicos/administración & dosificaciónRESUMEN
Striae distensae or stretch marks are a common complaint among women and can be distressing. The present study aimed to assess the efficacy of a mixture of low molecular weight hyaluronic acid and six amino acids when applied with a specific intradermal injection technique known as intra-mural fluid technique. A clinical study was carried out in 32 patients (with a dropout rate by 9.4%) with striae distensae alba (SA) in one or more of the following anatomical areas: breast, abdomen, inner thigh, trochanteric area, gluteal area, posterior supra-iliac area, and lumbar area. Product efficacy was assessed by the investigator using the Global Aesthetic Improvement Scale, while a Likert scale was used to evaluate to score the treatment tolerability and a QoL stretch marks questionnaire was used to investigate the patients' self-body image. The treatment was effective in improving the appearance of SA fifteen days after the second treatment and 6 months after the first treatment (and after a total of 4 treatments). The product efficacy and tolerability were also perceived by the patients during each treatment session. Our results suggest that the test treatment is a valid treatment option to decrease the appearance of SA. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors https://www.springer.com/00266.
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Ácido Hialurónico , Estrías de Distensión , Humanos , Femenino , Ácido Hialurónico/administración & dosificación , Ácido Hialurónico/efectos adversos , Estrías de Distensión/tratamiento farmacológico , Adulto , Aminoácidos/administración & dosificación , Aminoácidos/uso terapéutico , Resultado del Tratamiento , Inyecciones Intradérmicas , Adulto Joven , Persona de Mediana Edad , Satisfacción del Paciente/estadística & datos numéricos , Técnicas Cosméticas , Estética , Estudios de CohortesRESUMEN
BACKGROUND: Mycobacterium tuberculosis is the main causative agent of tuberculosis. BCG, the only licensed vaccine, provides inadequate protection against pulmonary tuberculosis. Controlled human infection models are useful tools for vaccine development. We aimed to determine a safe dose of aerosol-inhaled live-attenuated Mycobacterium bovis BCG as a surrogate for M tuberculosis infection, then compare the safety and tolerability of infection models established using aerosol-inhaled and intradermally administered BCG. METHODS: This phase 1 controlled human infection trial was conducted at two clinical research facilities in the UK. Healthy, immunocompetent adults aged 18-50 years, who were both M tuberculosis-naive and BCG-naive and had no history of asthma or other respiratory diseases, were eligible for the trial. Participants were initially enrolled into group 1 (receiving the BCG Danish strain); the trial was subsequently paused because of a worldwide shortage of BCG Danish and, after protocol amendment, was restarted using the BCG Bulgaria strain (group 2). After a dose-escalation study, during which participants were sequentially allocated to receive either 1 × 103, 1 × 104, 1 × 105, 1 × 106, or 1 × 107 colony-forming units (CFU) of aerosol BCG, the maximum tolerated dose was selected for the randomised controlled trial. Participants in this trial were randomly assigned (9:12), by variable block randomisation and using sequentially numbered sealed envelopes, to receive aerosol BCG (1 × 107 CFU) and intradermal saline or intradermal BCG (1 × 106 CFU) and aerosol saline. Participants were masked to treatment allocation until day 14. The primary outcome was to compare the safety of a controlled human infection model based on aerosol-inhaled BCG versus one based on intradermally administered BCG, and the secondary outcome was to evaluate BCG recovery in the airways of participants who received aerosol BCG or skin biopsies of participants who received intradermal BCG. BCG was detected by culture and by PCR. The trial is registered at ClinicalTrials.gov, NCT02709278, and is complete. FINDINGS: Participants were assessed for eligibility between April 7, 2016, and Sept 29, 2018. For group 1, 15 participants were screened, of whom 13 were enrolled and ten completed the study; for group 2, 60 were screened and 33 enrolled, all of whom completed the study. Doses up to 1 × 107 CFU aerosol-inhaled BCG were sufficiently well tolerated. No significant difference was observed in the frequency of adverse events between aerosol and intradermal groups (median percentage of solicited adverse events per participant, post-aerosol vs post-intradermal BCG: systemic 7% [IQR 2-11] vs 4% [1-13], p=0·62; respiratory 7% [1-19] vs 4% [1-9], p=0·56). More severe systemic adverse events occurred in the 2 weeks after aerosol BCG (15 [12%] of 122 reported systemic adverse events) than after intradermal BCG (one [1%] of 94; difference 11% [95% CI 5-17]; p=0·0013), but no difference was observed in the severity of respiratory adverse events (two [1%] of 144 vs zero [0%] of 97; 1% [-1 to 3]; p=0·52). All adverse events after aerosol BCG resolved spontaneously. One serious adverse event was reported-a participant in group 2 was admitted to hospital to receive analgesia for a pre-existing ovarian cyst, which was deemed unrelated to BCG infection. On day 14, BCG was cultured from bronchoalveolar lavage samples after aerosol infection and from skin biopsy samples after intradermal infection. INTERPRETATION: This first-in-human aerosol BCG controlled human infection model was sufficiently well tolerated. Further work will evaluate the utility of this model in assessing vaccine efficacy and identifying potential correlates of protection. FUNDING: Bill & Melinda Gates Foundation, Wellcome Trust, National Institute for Health Research Oxford Biomedical Research Centre, Thames Valley Clinical Research Network, and TBVAC2020.
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Vacuna BCG , Humanos , Adulto , Vacuna BCG/administración & dosificación , Vacuna BCG/inmunología , Vacuna BCG/efectos adversos , Masculino , Femenino , Reino Unido , Persona de Mediana Edad , Inyecciones Intradérmicas , Adulto Joven , Administración por Inhalación , Mycobacterium bovis/inmunología , Adolescente , Aerosoles , Vacunas Atenuadas/administración & dosificación , Tuberculosis/prevención & controlRESUMEN
In response to the Mpox domestic epidemic, South Korea initiated a nationwide vaccination program in May 2023, administering a 0.1 mL intradermal dose of JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) to a high-risk group. To investigate the adverse reactions after intradermal JYNNEOS vaccination, an anonymous online survey was conducted at the National Medical Center from May 22 to July 31, 2023. Overall, 142 individuals responded. Over 80% of the respondents reported local reactions of predominantly mild severity. The predominant local reactions were pruritus, redness, and swelling; their incidence rates after the first dose were 66.2%, 48.1%, and 49.4%, respectively; the corresponding rates after the second dose were 69.2%, 60.6%, and 53.8%. Fewer respondents reported systemic symptoms. The most common systemic symptom was fatigue, the incidence rates of which after the first and second doses were 37.7% and 24.6%, respectively. Overall, the intradermally administered JYNNEOS vaccine appeared well tolerated.
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Mpox , Vacuna contra Viruela , Vacunas , Humanos , República de Corea/epidemiología , Vacunación/efectos adversos , Vacuna contra Viruela/efectos adversos , Inyecciones IntradérmicasRESUMEN
PURPOSE: Hollow-type microneedles (hMNs) are a promising device for the effective administration of drugs into intradermal sites. Complete insertion of the needle into the skin and administration of the drug solution without leakage must be achieved to obtain bioavailability or a constant effect. In the present study, several types of hMN with or without a rounded blunt tip micropillar, which suppresses skin deformation, around a hollow needle, and the effect on successful needle insertion and administration of a drug solution was investigated. Six different types of hMNs with needle lengths of 1000, 1300, and 1500 µm with or without a micropillar were used. METHODS: Needle insertion and the disposition of a drug in rat skin were investigated. In addition, the displacement-force profile during application of hMNs was also investigated using a texture analyzer with an artificial membrane to examine needle factors affecting successful insertion and administration of a drug solution by comparing with in vivo results. RESULTS: According to the results with the drug distribution of iodine, hMN1300 with a micropillar was able to successfully inject drug solution into an intradermal site with a high success rate. In addition, the results of displacement-force profiles with an artificial membrane showed that a micropillar can be effective for depth control of the injected solution as well as the prevention of contact between the hMN pedestal and the deformed membrane. CONCLUSION: In the present study, hMN1300S showed effective solution delivery into an intradermal site. In particular, a micropillar can be effective for depth control of the injected solution as well as preventing contact between the hMN pedestal and the deformed membrane. The obtained results will help in the design and development of hMNs that ensure successful injection of an administered drug.
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Sistemas de Liberación de Medicamentos , Piel , Ratas , Animales , Microinyecciones , Inyecciones Intradérmicas , Sistemas de Liberación de Medicamentos/métodos , Agujas , Membranas Artificiales , Administración CutáneaRESUMEN
Sterile water injections (SWI) is a nonpharmacologic pain relief option to treat back pain in labor. This case report describes and discusses the use of SWI in the context of an obstetric retrieval of a 29-year-old woman who was transferred by the Royal Flying Doctor Service South Eastern Section. It provides an overview of SWI, discusses the relevance for medical transport, and offers suggestions for medical transport professionals.
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Dolor de Parto , Embarazo , Femenino , Humanos , Adulto , Inyecciones Intradérmicas , Dolor de Parto/tratamiento farmacológico , Manejo del Dolor , AguaRESUMEN
Hyaluronic acid (HA) is a remarkably multifaceted biomacromolecule, playing a role in regulating myriad biological processes such as wound healing, tissue regeneration, anti-inflammation, and immunomodulation. Crosslinked high- and low-molecular-weight hyaluronic acid hydrogels achieve higher molar concentrations, display slower degradation, and allow optimal tissue product diffusion, while harnessing the synergistic contribution of different-molecular-weight hyaluronans. A recent innovation in the world of hyaluronic acid synthesis is represented by NAHYCO® Hybrid Technology, a thermal process leading to hybrid cooperative hyaluronic acid complexes (HCC). This review summarizes the current literature on the in vitro studies and in vivo applications of HCC, from facial and body rejuvenation to future perspectives in skin wound healing, dermatology, and genitourinary pathologies.
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Ácido Hialurónico , Medicina Regenerativa , Inyecciones Intradérmicas , Cicatrización de Heridas , Hidrogeles/uso terapéuticoRESUMEN
OBJECTIVES: The aim of this study was to assess the safety and immunogenicity of a dose-sparing fractional intradermal (ID) booster strategy with the mRNA-1273 COVID-19 vaccine. METHODS: COVID-19 naive adults aged 18-30 years were recruited from a previous study on primary vaccination regimens that compared 20 µg ID vaccinations with 100 µg intramuscular (IM) vaccinations with mRNA-1273 as the primary vaccination series. Participants previously immunized with ID regimens were randomly assigned (1:1) to receive a fractional ID booster dose (20 µg) or the standard-of-care intramuscular (IM) booster dose (50 µg) of the mRNA-1273 vaccine, 6 months after completing their primary series (ID-ID and ID-IM group, respectively). Participants that had received a full dose IM regimen as the primary series, received the IM standard-of-care booster dose (IM-IM group). In addition, COVID-19 naive individuals aged 18-40 years who had received an IM mRNA vaccine as the primary series were recruited from the general population to receive a fractional ID booster dose (IM-ID group). Immunogenicity was assessed using IgG anti-spike antibody responses and neutralizing capacity against SARS-CoV-2. Cellular immune responses were measured in a sub-group. Safety and tolerability were monitored. RESULTS: In January 2022, 129 participants were included in the study. Fractional ID boosting was safe and well tolerated, with fewer systemic adverse events compared with IM boosting. At day 28 post-booster, anti-spike S1 IgG geometric mean concentrations were 9106 (95% CI, 7150-11 597) binding antibody units (BAU)/mL in the IM-IM group and 4357 (3003-6322) BAU/mL; 6629 (4913-8946) BAU/mL; and 5264 (4032-6873) BAU/mL in the ID-IM, ID-ID, and IM-ID groups, respectively. DISCUSSION: Intradermal boosting provides robust immune responses and is a viable dose-sparing strategy for mRNA COVID-19 vaccines. The favourable side-effect profile supports its potential to reduce vaccine hesitancy. Fractional dosing strategies should be considered early in the clinical development of future mRNA vaccines to enhance vaccine availability and pandemic preparedness.