Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 124
Filter
3.
J Biotechnol Biomed ; 7(3): 314-328, 2024.
Article in English | MEDLINE | ID: mdl-39119011

ABSTRACT

Atopic dermatitis (AD) is a prevalent inflammatory skin condition impacting both children and adults globally, with a prevalence of 15-30%. It ranks as the most prevalent skin disorder based on disability-adjusted life-years by the World Health Organization. It presents with symptoms like skin irritation, redness, dryness, itchiness, and vesicular blisters and commonly coexists with other atopic symptoms like allergic rhinitis, asthma, and food allergies. The pathophysiology involves a complex interplay of genetic predispositions, immunological dysfunctions, and environmental factors leading to tissue inflammation and disrupted skin barrier integrity. Alopecia areata is characterized by nonscarring hair loss and shares correlations with AD including a higher prevalence of atopic diseases, shared intracellular mechanisms involving the JAK-STAT pathway, and potential treatment overlap such as dupilumab. These correlations could direct new areas of research and increased insight for both diseases. Treatment of AD requires a personalized approach due to its complex, multifactorial nature integrating nonpharmacological interventions like skin hydration and trigger avoidance as well as topical and systemic approaches, if necessary, with topical corticosteroids being the first line for flares; long term corticosteroid use poses risk for adverse effects like skin atrophy. Severe cases may require systemic treatments or phototherapy. Future treatment prospects include targeting the dysbiotic microbiome and identifying biomarkers for tailored therapeutic strategies, emphasizing the importance of personalized medicine in optimizing AD management.

5.
Lasers Surg Med ; 56(5): 466-473, 2024 07.
Article in English | MEDLINE | ID: mdl-38693708

ABSTRACT

OBJECTIVES: To investigate the efficacy of Fractional Radiofrequency Microneedling (FRM) in treating corticosteroid-induced facial erythema. METHODS: A retrospective study was conducted involving eight patients diagnosed as corticosteroid-induced facial erythema. Each patient underwent a single session of FRM. Evaluative measures included Clinician's Erythema Assessment (CEA), Patient's Self-Assessment (PSA), assessment of telangiectasia severity, procedure-associated pain (10-point scale), patient satisfaction (3-point scale) and secondary outcomes. RESULTS: The study found a 75% success rate and 100% effectiveness rate in alleviating erythema symptoms. CEA and PSA scores decreased by 67.7% and 78.1%, respectively. No cases of erythema rebound were recorded during the 3-month follow-up period. CONCLUSIONS: FRM demonstrated effectiveness and safety in treating facial erythema, offering promising advancement in dermatologic therapeutics.


Subject(s)
Adrenal Cortex Hormones , Erythema , Facial Dermatoses , Needles , Adult , Female , Humans , Middle Aged , Adrenal Cortex Hormones/adverse effects , Erythema/etiology , Erythema/therapy , Facial Dermatoses/therapy , Patient Satisfaction , Radiofrequency Therapy , Retrospective Studies , Treatment Outcome
6.
Cureus ; 16(3): e55373, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38562369

ABSTRACT

Introduction Topical corticosteroids are a valuable tool for treating many dermatoses, offering anti-inflammatory and immunosuppressive properties. However, preexisting knowledge gaps and safety concerns may hinder treatment compliance. This study aims to evaluate knowledge and attitudes towards topical corticosteroids among former users within the general population of Saudi Arabia. Methods This cross-sectional study utilized an online survey to collect data. Knowledge was assessed through three dimensions: indications, proper use, and adverse reactions. Attitudes were assessed using the Topical Corticosteroid Phobia (TOPICOP) scale. Results Among the 397 respondents, 80.9% were females, 51.1% had suffered from a dermatological disease, and 76.3% had a bachelor's or higher educational level. When assessing knowledge, female participants (6.22±2.02) displayed significantly higher scores compared to male participants (5.26 ± 2.23) (p<0.001). Participants with dermatological diseases provided more accurate answers compared to those without. In assessing phobia towards topical corticosteroids, participants aged 18-25 years had lower topical corticosteroid phobia scores (31.06 ± 5.91), whereas those aged 56 years or more had higher scores (35.38 ± 6.04), p<0.001. Single participants had significantly lower topical corticosteroid phobia scores (32.27 ± 6.06) compared to those who were married (33.87 ±5.95) (p=0.010). Additionally, participants with dermatological diseases had higher scores in the behaviors subcategory despite having lower Global TOPICOP scores (32.58 ± 5.7) (p=0.033). Conclusion Enhancing knowledge about topical corticosteroids is crucial for mitigating corticophobia and promoting better adherence. To address gaps in knowledge, dermatologists should expand educational initiatives to include vulnerable populations, explicitly targeting males and older individuals.

7.
Med. oral patol. oral cir. bucal (Internet) ; 29(2): e219-e226, Mar. 2024. tab, graf, ilus
Article in English | IBECS | ID: ibc-231225

ABSTRACT

Background: Chronic graft-versus-host-disease (cGVHD) is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The oral cavity is one of the most frequently affected anatomic sites and is affected in 70% of all patients who develop cGVHD. The objective of this study was to determine the therapeutic response to topical corticosteroids and clinical outcome of patients with oral cGVHD using the 2014 NIH consensus criteria. Material and Methods: The oral manifestations of cGVHD were collected at the first and the follow-up (FU) visits after the therapeutic treatment of oral GVHD. The FU intervals were: FU0, first visit; FU1, 0-1 month; FU2, 1-3 months; FU3, 3-6 months; FU4, 6-9 months; and FU5, 9-12 months. The oral cGVHD activity was assessed using the NIH modification of the Schubert Oral Mucosa Rating Scale (OMRS) and Thongprasom sign score. The functional impact was assessed by the organ-specific severity score. Results: Fourteen patients (93.3%) at FU0 were being treated with at least one form of systemic immunosuppressive therapy, i.e., prednisolone, cyclosporin, and tacrolimus. The OMRS was reduced between FU0 and FU3 (p < 0.001), FU0 and FU4 (p < 0.001), and FU0 and FU5 (p = 0.004). The organ-specific severity scores were also reduced between FU0 and FU4 (p = 0.016), and FU0 and FU5 (p = 0.001). There was no significant difference in the highest Thongprasom sign score between all follow-up intervals (FU0-FU5) (p = 0.201). One patient (6.7%) at FU4 and three patients (20.0%) at FU5 did not receive topical corticosteroid therapy for oral cGVHD....(AU)


Subject(s)
Humans , Male , Female , Graft vs Host Disease , Adrenal Cortex Hormones , Hematopoietic Stem Cell Transplantation , Glucocorticoids/therapeutic use , Oral Medicine , Oral Health , Pathology, Oral , United States
8.
Cureus ; 16(1): e53055, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38410340

ABSTRACT

Periorbital atopic dermatitis (AD) is a common sign in ophthalmological practice and usually has a persistent and relapsing course. Treatment with topical corticosteroids has various side effects associated with their usage. Tacrolimus topical ointment has unique immunomodulatory properties that decrease skin inflammation and pruritus in AD. In this case series, we present a prospective case series of five patients (three males and two females) who received topical application of tacrolimus ointment 0.1-0.03% in the periorbital area twice daily for one to four weeks. The pre- and post-treatment images of all patients were recorded to compare the effects of the treatment. The cases were selected from patients attending the outpatient clinics of East Jeddah Hospital, Saudi Arabia. All patients were suffering from AD. Patients underwent a clinical assessment by tactile inspection (location, size, color, and surface condition) in the first week, secondweek, third month, and first year. We may conclude from this study that tacrolimus showed promising outcomes and is safe and effective for the treatment of flares or resistant periorbital AD in both adults and children.

9.
Acta Obstet Gynecol Scand ; 103(6): 1175-1182, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38383115

ABSTRACT

INTRODUCTION: Differentiated vulvar intraepithelial neoplasia (dVIN) is a high-risk preinvasive vulvar lesion and precursor of human papillomavirus-independent vulvar squamous cell carcinoma (VSCC). Due to its rarity, literature data on its malignant potential are scant. The aim of the study is to assess the risk of developing VSCC in patients surgically treated for dVIN not associated with VSCC (solitary dVIN) and the risk of VSCC recurrence in patients treated for dVIN associated with VSCC (dVIN-VSCC) at first diagnosis. MATERIAL AND METHODS: A historical cohort study was performed in a northern Italy referral center for vulvar neoplasms. All consecutive women surgically treated for histologically confirmed dVIN from 1994 to 2021 were collected. Primary outcome was cancer risk or recurrent cancer risk, secondary outcomes were risk factors associated with VSCC development or recurrence. Kaplan-Meier method and log-rank test were used to estimate cancer risk or recurrent cancer risk differences and uni- and multivariate Cox regression analyses to identify risk factors associated with VSCC development in solitary dVIN and recurrence of dVIN-VSCC. RESULTS: Seventy-six patients with dVIN at preoperative biopsy were included: at excisional specimens 44 were solitary dVIN and 32 were dVIN-VSCC. The absolute risk of VSCC development after solitary dVIN treatment was 43.2% with median time to to VSCC diagnosis of 25.4 months (range 3.5-128.0 months). VSCC recurrence absolute risk in treated dVIN-VSCC patients was 31.3% with median time to VSCC recurrence of 52.9 months (range 6.5-94.8 months). At uni- and multivariate regression analyses, only compliant topical ultrapotent corticosteroid treatment after solitary dVIN excision showed an ability to prevent VSCC development. No protective effect by corticosteroid treatment was shown for VSCC recurrence in dVIN-VSCC patients. Smoking was associated with higher cancer recurrence risk in dVIN-VSCC patients on both uni- and multivariate regression analyses. CONCLUSIONS: Patients with dVIN have a high risk of developing both primary and recurring VSCC. Early recognition, long-term follow up, and compliant ultrapotent topical corticosteroid treatment are recommended.


Subject(s)
Carcinoma in Situ , Carcinoma, Squamous Cell , Neoplasm Recurrence, Local , Vulvar Neoplasms , Humans , Female , Vulvar Neoplasms/pathology , Carcinoma in Situ/pathology , Carcinoma in Situ/therapy , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Carcinoma, Squamous Cell/pathology , Prognosis , Follow-Up Studies , Cohort Studies , Adult , Risk Factors , Aged , Italy/epidemiology
10.
Dermatology ; 240(2): 195-204, 2024.
Article in English | MEDLINE | ID: mdl-38163426

ABSTRACT

INTRODUCTION: Vulvar lichen sclerosus (VLS) is characterized by progressive anatomical changes which become increasingly severe and irreversible. The objective of this study was to investigate if a "window of opportunity" exists in VLS, i.e., to assess if an early treatment may prevent disease progression and facilitate clearance of symptoms and/or signs. METHODS: This retrospective, cohort study included VLS patients treated for the first time with a topical corticosteroid, namely with mometasone furoate 0.1% ointment, for 12 weeks (2016-2021). Scoring of subjective symptoms (global subjective score, GSS, and dyspareunia) and clinical features (global objective score [GOS] and sclerosis-scarring-atrophy) was performed at baseline (T0) and at the control visit (T1). We assessed if the achievement of clearance in GSS, GOS, sclerosis-scarring-atrophy, or dyspareunia depended on the time elapsed between VLS onset and treatment initiation. RESULTS: Among the 168 patients (59.2 ± 13.2 years) included, the median time between VLS onset and first treatment was 14.0 months. At T1, 48.8% of patients achieved clearance of GSS, 28% of GOS and 11.9% of both GSS and GOS, 57.9% of dyspareunia, and 19.2% of sclerosis-scarring-atrophy. The logistic regression model showed that each 10-month increase in treatment initiation adversely affected the clearance of GSS while starting treatment within 6 months of disease onset was significantly associated with clearance of GOS and sclerosis-scarring-atrophy. CONCLUSION: Early treatment is crucial in determining a complete healing of VLS-related symptoms and signs, especially of tissue sclerosis-scarring-atrophy, which appear poorly responsive, or even unresponsive, after the earliest stages of the disease. Thus our findings provide evidence for a "window of opportunity" in VLS treatment.


Subject(s)
Dyspareunia , Vulvar Lichen Sclerosus , Female , Humans , Vulvar Lichen Sclerosus/drug therapy , Vulvar Lichen Sclerosus/chemically induced , Vulvar Lichen Sclerosus/diagnosis , Cohort Studies , Cicatrix/drug therapy , Retrospective Studies , Sclerosis/chemically induced , Sclerosis/drug therapy , Dyspareunia/etiology , Dyspareunia/chemically induced , Treatment Outcome , Glucocorticoids/therapeutic use , Atrophy/drug therapy , Atrophy/chemically induced
11.
Pediatr Dermatol ; 41(2): 221-228, 2024.
Article in English | MEDLINE | ID: mdl-38126606

ABSTRACT

BACKGROUND: Concerns about the use of topical corticosteroids (TCS) in pediatric eczematous dermatitis management often hinder effective treatment. Limited data exist regarding the prevalence of these concerns and the effectiveness of interventions. This study aimed to assess the prevalence of TCS concerns among caregivers and determine the effectiveness of video education in mitigating these concerns. METHODS: A single-center prospective study was conducted from 2022 to 2023, involving caregivers of children under 18 years with eczematous dermatitis. Baseline and post-intervention questionnaires were administered after a 4-week period. Caregivers received video education on TCS use, and the TOPICOP score was evaluated before and after viewing the video. RESULTS: The study included 150 caregivers, 85.3% female and 74% had a child with atopic dermatitis. The prevalence of TCS concerns among Thai caregivers was 62%. Following video education, the prevalence of TCS concerns significantly decreased to 10.7%. Mean belief score decreased from 43.81 ± 13.45 to 31.85 ± 16.56, mean worry score decreased from 56.22 ± 18.27 to 40.41 ± 18.55 and mean total TOPICOP score decreased from 50.02 ± 12.65 to 36.13 ± 13.52 (p-value <.001). The intervention also resulted in reduced disease exacerbations, duration of the rash, and duration of TCS use. The optimal TOPICOP cut-off score to predict TCS concerns was identified as 43.06. CONCLUSION: Video education effectively alleviated TCS concerns among caregivers, addressing beliefs, worries, disease exacerbations, and side effects. Integration of this intervention into the management of pediatric eczematous dermatitis can yield optimal outcomes.


Subject(s)
Dermatologic Agents , Eczema , Child , Humans , Female , Adolescent , Male , Caregivers , Prospective Studies , Glucocorticoids/therapeutic use , Surveys and Questionnaires , Dermatologic Agents/therapeutic use , Disease Progression , Eczema/drug therapy , Adrenal Cortex Hormones/therapeutic use
12.
J Dermatolog Treat ; 35(1): 2298880, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38156462

ABSTRACT

PURPOSE: In this study, we will investigate the possible side effects of psoriasis patients using long-term topical corticosteroids (TCS) such as adrenal insufficiency, Cushing's Syndrome (CS) and osteoporosis and determine how these side effects develop. MATERIAL AND METHODS: Forty-nine patients were included in the study. The patients were divided into two groups based on the potency of the topical steroid they took and the patients' ACTH, cortisol and bone densitometer values were evaluated. RESULTS: There was no significant difference between the two groups regarding the development of surrenal insufficiency, CS and osteoporosis. One patient in group 1 and 4 patients in group 2 were evaluated as iatrogenic CS. ACTH stimulation tests of these patients in group 2 showed consistent results with adrenal insufficiency, while no adrenal insufficiency was detected in the patient in Group 1. Patients who used more than 50g of superpotent topical steroids per week compared to patients who used 50g of superpotent topical steroids per week. It was identified that patients who used more than 50g of superpotent topical steroids had significantly lower cortisol levels, with a negatively significant correlation between cortisol level and the amount of topical steroid use (p < .01).Osteoporosis was detected in 3 patients in group 1 and 8 patients in Group 2. Because of the low number of patients between two groups, statistical analysis could not be performed to determine the risk factors. CONCLUSIONS: Our study is the first study that we know of that investigated these three side effects. We have shown that the development of CS, adrenal insufficiency and osteoporosis in patients who use topical steroids for a long time depends on the weekly TCS dosage and the risk increases when it exceeds the threshold of 50 grams per week. therefore, our recommendation would be to avoid long-term use of superpotent steroids and to choose from the medium-potent group if it is to be used.


Subject(s)
Adrenal Insufficiency , Cushing Syndrome , Dermatologic Agents , Osteoporosis , Psoriasis , Humans , Cushing Syndrome/chemically induced , Hydrocortisone/adverse effects , Glucocorticoids/therapeutic use , Adrenal Insufficiency/chemically induced , Steroids/therapeutic use , Osteoporosis/chemically induced , Osteoporosis/drug therapy , Psoriasis/drug therapy , Psoriasis/chemically induced , Dermatologic Agents/therapeutic use , Adrenocorticotropic Hormone/therapeutic use
13.
Patient Prefer Adherence ; 17: 2761-2772, 2023.
Article in English | MEDLINE | ID: mdl-37936715

ABSTRACT

Background: Anxiety about using topical corticosteroids (TCS) for childrens among parents and caretakers is a common cause of treatment failure and an overall decline in the child's quality of life. The purpose of this study was to examine the perspectives and worries of parents of Atopic dermatitis (AD) children regarding TCS. Additionally, we investigate the degree of phobia in relation to the use of the TCS. Materials and Methods: A convenience sample of 301 parents of children who had been identified with atopic dermatitis from two hospitals in Taif city were enrolled in this study. Parents who chose to participate were sent a questionnaire measuring their level of fear of TCS using the TOPICOP© scale, which also included inquiries about their demographics and clinical characteristics. Multivariate analysis was used to determine what factors influence people's overall levels of fear. Results: The median global TOPICOP score was 66.6% (IQR 60.4-75%), SD 12.83%, which showed that nearly two-thirds of the participants showed corticosteroid phobia. A multifactorial ANOVA model showed that parents who had a female child with AD and mothers who had experienced drug allergies had a significant influence on TOPICOP scores (P<0.05). Conclusion: Topical corticosteroid phobia is widespread among parents of children patients with AD in Taif. Regarding the utilization of TCS, we place a strong emphasis on the significant role that physicians play as sources of reliable information and proper education.

14.
BMC Oral Health ; 23(1): 898, 2023 11 21.
Article in English | MEDLINE | ID: mdl-37990233

ABSTRACT

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disease of the oral cavity that affects many patients' daily living activities. Topical corticosteroids are the first-line drug for treating OLP. The Oral Impact on Daily Performances index (OIDP) is an Oral-Health-Related Quality of Life (OHRQoL) measure developed to assess the ultimate impacts. The aims of this study were to evaluate the clinical, pain and OHRQoL responses after treating OLP patients with topical corticosteroids for 1 month, and secondly to assess the relationships of changes in the clinical sign score, pain score, and OHRQoL. METHODS: Seventy-two OLP patients were treated by topical corticosteroids based on their dentists' clinical judgments. Clinical and patient-based outcomes were assessed at baseline and follow-up visit. The clinical outcomes were evaluated by the highest and total Thongprasom sign score. Patient-based outcomes were evaluated by numeric rating scale (NRS) and OIDP. The self-rated overall changes in quality of life during the 1-month treatment period using the Patient Global Impression of Change (PGIC) were also recorded at the follow-up visit. RESULTS: This study comprised 59 women and 13 men. All clinical and patient-based outcomes were significantly reduced after 1-month treatment with topical corticosteroids (P < 0.01). The most commonly affected activities were Emotional stability, followed by Eating and Cleaning the oral cavity. Forty-six percent reported the same or up to moderately improved, while 54% had a greatly improved quality of life as assessed by PGIC. There were no significant differences in the improvement of clinical and patient-based outcomes between these groups. There were significant relationships between the differences in the highest Thongprasom sign score and the differences in total Thongprasom sign score (r = 0.293; P < 0.05), and the differences in total OIDP percentage score and the difference in pain score (r = 0.427; P < 0.001). The differences in the total Thongprasom sign score also significantly related to the difference in the total OIDP percentage score (r = 0.335; P < 0.01). CONCLUSIONS: Topical corticosteroids were significantly effective after 1-month treatment of OLP based on the clinical and patient-based outcomes. The OHRQoL improvement was significantly related to the reductions in pain and clinical severity. TRIAL REGISTRATION: The trial was registered at the Thai Clinical Trials Registry (TCTR identifier: TCTR 20221110001).


Subject(s)
Lichen Planus, Oral , Quality of Life , Female , Humans , Male , Glucocorticoids/therapeutic use , Lichen Planus, Oral/drug therapy , Longitudinal Studies , Pain , Southeast Asian People
15.
Osteoarthr Cartil Open ; 5(3): 100382, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37426293

ABSTRACT

Objective: To examine the efficacy and safety of topical corticosteroid over 6 weeks in patients with symptomatic hand osteoarthritis. Design: In a randomized, double-blind, placebo-controlled trial, community-based participants with hand osteoarthritis were randomly assigned (1:1) to topical Diprosone OV (betamethasone dipropionate 0.5 â€‹mg/g in optimised vehicle, n=54) or placebo (plain paraffin, n=52) ointment to painful joints 3 times daily for 6 weeks. Primary outcome was pain reduction [assessed by 100 â€‹mm visual analogue scale (VAS)] at 6 weeks. Secondary outcomes included changes in pain and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), and Michigan Hand Outcomes Questionnaire (MHQ) at 6 weeks. Adverse events were recorded. Results: Of 106 participants (mean age 64.2 years, 85.9% female), 103 (97.2%) completed the study. Change in VAS at 6 weeks was similar in the Diprosone OV and placebo groups (-19.9 vs. -20.9, adjusted difference 0.6, 95% CI -8.9 to 10.2). There were no significant between-group differences in change in AUSCAN pain [adjusted difference 25.8 (-16.0 to 67.5)], AUSCAN function [21.2 (-55.0 to 97.4)], FIHOA [-0.1 (-1.7 to 1.5)], or MHQ [-1.2 (-6.0 to 3.6)]. Incidence of adverse events was 16.7% in Diprosone OV and 19.2% in placebo group. Conclusions: Topical Diprosone OV ointment, although well-tolerated, was no better than placebo in improving pain or function over 6 weeks in patient with symptomatic hand osteoarthritis. Future studies should consider examining joints with synovitis and whether delivery approaches enhancing transdermal penetration of corticosteroids into joints are effective in hand osteoarthritis. Trial registration: ACTRN 12620000599976. Registered May 22, 2020.

16.
Expert Rev Clin Immunol ; 19(5): 499-516, 2023 05.
Article in English | MEDLINE | ID: mdl-36970858

ABSTRACT

INTRODUCTION: Palmoplantar pustulosis (PPP) is a chronic inflammatory skin disease belonging to the localized form of pustular psoriasis. It is characterized by sterile pustule formation in palms and soles and a recurrent disease course. Although we have many treatments for PPP, there is no authoritative guidance. AREAS COVERED: A thorough search of PubMed was conducted to identify studies in PPP from 1973 onwards, with additional references to specific articles. Any treatment methods were outcomes of interest, including topical treatment, systemic treatment, biologics, other targeted treatments, phototherapy, and tonsillectomy. EXPERT OPINION: Topical corticosteroids are suggested as first-line therapy. Oral acitretin has become the most applied systemic retinoid recommended in PPP without joint involvement. For patients with arthritis, immunosuppressants like cyclosporin A and methotrexate are more recommended. UVA1, NB-UVB, and 308-nm excimer laser are effective phototherapy options. The combinations of topical or systemic agents and phototherapy may enhance the efficacy, particularly in recalcitrant cases. Secukinumab, ustekinumab, and apremilast are the most investigated targeted therapies. However, heterogeneous reported outcomes in clinical trials provided low-to-moderate quality evidence of their efficacy. Future studies are required to address these evidence gaps. We suggest managing PPP based on the acute phase, maintenance phase, and comorbidities.


Subject(s)
Dermatologic Agents , Psoriasis , Humans , Psoriasis/drug therapy , Cyclosporine/therapeutic use , Acitretin/therapeutic use , Immunosuppressive Agents/therapeutic use , Dermatologic Agents/therapeutic use , Chronic Disease
17.
Aliment Pharmacol Ther ; 57(10): 1117-1130, 2023 05.
Article in English | MEDLINE | ID: mdl-36890134

ABSTRACT

BACKGROUND: Questions remain regarding the safety of swallowed topical corticosteroids in eosinophilic oesophagitis (EoE). AIM: To assess the safety of an investigational formulation of budesonide (budesonide oral suspension; BOS) from six trials. METHODS: Safety data were integrated from six trials (healthy adults: SHP621-101 [phase 1]; patients with EoE: MPI 101-01 and MPI 101-06 [phase 2]; SHP621-301, SHP621-302 and SHP621-303 [phase 3]) for participants who received ≥1 dose of study drug (BOS 2.0 mg twice daily [b.i.d.], BOS any dose [including BOS 2.0 mg b.i.d.] and placebo). Adverse events (AEs), laboratory testing, bone density and adrenal AEs were assessed. Exposure-adjusted incidence rates were calculated for AEs and AEs of special interest (AESIs). RESULTS: Overall, 514 unique participants were included (BOS 2.0 mg b.i.d., n = 292; BOS any dose, n = 448; placebo, n = 168). The BOS 2.0 mg b.i.d., BOS any dose and placebo groups totalled 93.7, 122.4 and 25.0 participant-years of exposure (PY), respectively. Proportions of treatment-emergent AEs (TEAEs) and AESIs (any) reported were higher for BOS than placebo; however, most were mild/moderate in severity. The most commonly reported AESIs (exposure-adjusted incidence rates [per 100 PY]) in the BOS 2.0 mg b.i.d., BOS any dose and placebo groups were infections (133.5, 154.4 and 136.2, respectively) and gastrointestinal AEs (84.3, 80.9 and 92.1, respectively). Adrenal AEs were more frequent with BOS 2.0 mg b.i.d. and BOS any dose than placebo (44.8, 34.3 and 24.0, respectively). TEAEs and AESIs related to study drug or leading to discontinuation were infrequent. CONCLUSIONS: BOS was well-tolerated; most TEAEs with BOS were mild/moderate in severity. GOV NUMBERS: SHP621-101 (no clinical trials registration number), MPI 101-01 (NCT00762073), MPI 101-06 (NCT01642212), SHP621-301 (NCT02605837), SHP621-302 (NCT02736409) and SHP621-303 (NCT03245840).


Subject(s)
Budesonide , Eosinophilic Esophagitis , Adult , Humans , Eosinophilic Esophagitis/drug therapy , Double-Blind Method , Glucocorticoids , Suspensions
18.
Gerokomos (Madr., Ed. impr.) ; 34(4): 282-284, 2023. ilus
Article in Spanish | IBECS | ID: ibc-229004

ABSTRACT

Introducción: Hasta la fecha, la manifestación de una úlcera perianalprovocada por una pomada antihemorroidal no se ha descrito confrecuencia. Sin embargo, se ha objetivado un incremento de loscasos durante la pandemia de COVID-19. Caso clínico: Varónde 82 años independiente, que presentó una úlcera perianal de35,8 cm² sin ninguna patología ni enfermedad concomitante queexplicara su causa. La aplicación de criterios de exclusión exhaustivos,incluida una biopsia para rechazar el pioderma gangrenoso,identificó una pomada rectal hemorroidal como la causa de la úlcera.Plan de actuación: La herida curó tras aplicar una intervenciónmultidisciplinaria y una terapia con factores de crecimientoautólogos. Discusión y conclusiones: Este caso ha sido escasamentereportado en la literatura, aunque esta pomada hemorroidal secomercializa desde hace más de 40 años. Se recomienda evaluaciónmédica antes de la prescripción. (AU)


Introduction: Perianal ulcers resulting from the use of hemorrhoidalointments have been rarely reported to date. Nevertheless, therehas been a surge in the number of cases reported during theCOVID-19 pandemic. Case report: An independent 82-year-oldmale experienced a 35,80 cm² perianal ulcer, with no underlyingcondition or concomitant disease that could explain the cause ofthe ulcer. The application of thorough exclusion criteria, including abiopsy to rule out pyoderma gangrenosum, led to the identificationof a hemorrhoidal rectal ointment as the cause. Action plan: Theulcer healed completely when a multidisciplinary intervention and anautologous growth factors advanced therapy were applied. Discussionand conclusions: This case has been scarcely reported in the literature,although this hemorrhoidal ointment has been on the market for over40 years. Medical assessment before prescription and patients’ followup is recommended. (AU)


Subject(s)
Humans , Male , Aged, 80 and over , Fissure in Ano , Lidocaine , Adrenal Cortex Hormones , Pandemics , Coronavirus/immunology
20.
Int Wound J ; 20(2): 499-507, 2023 Feb.
Article in English | MEDLINE | ID: mdl-35880316

ABSTRACT

A high incidence of severe acute radiation dermatitis (ARD) has been reported for cancer patients treated by proton beam therapy (PBT). This observational study investigated the prognostic factors and treatment outcomes of ARD among patients with nasopharyngeal carcinoma (NPC) treated with PBT. Fifty-seven patients with newly diagnosed NPC and treated with PBT were enrolled. ARD was recorded weekly based on the criteria of Common Terminology Criteria for Adverse Events version 4.0 at treatment visits (1st to 7th weeks) and 1 week (8th week) and 1 month (11th week) after the completion of PBT. The maximum ARD grade was 1, 2, and 3 in 26 (45.6%), 24 (42.1%), and 7 (12.3%) of the patients, respectively. The peak incidence of grade 2 and 3 ARD was observed during the period of the 6th to 8th weeks. Treatment of ARD included topical corticosteroid alone in 24 (42.1%) patients, topical corticosteroid plus silver sulfadiazine in 33 (57.9%) patients, and non-adhering silicone dressing to cover severe skin wound area in 25 (43.8%) patients. In the 11th week, most grade 2 and 3 ARD had disappeared and 93.0% of the patients had ARD of grade 1 or lower. In the binary logistic regression model, we identified habitual smoking (odds ratio [OR]: 5.2, 95% confidence interval [CI]: 1.3-18.8, P = .012) and N2 to N3 nodal status (OR: 4.9, 95% CI: 1.6-15.4, P = .006) as independent predictors of grade 2 and 3 ARD. The results show ARD is a major concern for patients with NPC treated with PBT, especially those with habitual smoking or advanced nodal status. Topical corticosteroid, silver sulfadiazine, and non-adhering silicone dressing are effective for treating ARD induced by PBT.


Subject(s)
Dermatologic Agents , Nasopharyngeal Neoplasms , Proton Therapy , Radiodermatitis , Humans , Proton Therapy/adverse effects , Proton Therapy/methods , Nasopharyngeal Carcinoma/radiotherapy , Nasopharyngeal Carcinoma/complications , Nasopharyngeal Carcinoma/drug therapy , Prognosis , Silver Sulfadiazine , Radiodermatitis/therapy , Radiodermatitis/drug therapy , Treatment Outcome , Dermatologic Agents/therapeutic use , Glucocorticoids , Nasopharyngeal Neoplasms/radiotherapy , Nasopharyngeal Neoplasms/complications , Nasopharyngeal Neoplasms/drug therapy
SELECTION OF CITATIONS
SEARCH DETAIL