scholarly journals Treatment with clobetasol propionate 0.025% topical therapy in various dermatoses

2021 ◽  
Vol 10 (1) ◽  
pp. 250
Author(s):  
Ashwini Guttedar ◽  
Nitin Mishra ◽  
Sanjay Kumar Gupta ◽  
Atul Dilip Mohankar ◽  
Karan Sancheti ◽  
...  
Keyword(s):  
Topical Therapy ◽  
Case Series ◽  
The United States ◽  
Hand Eczema ◽  
Clobetasol Propionate ◽  
Systemic Absorption ◽  
Chronic Hand Eczema ◽  
High Penetration ◽  
United States Food ◽  
Anti Inflammatory

Owing to their anti-inflammatory and vasoconstrictive properties. Topical corticosteroids (TCs) provide benefits in various dermatological conditions, including atopic eczema, psoriasis, chronic hand eczema, and localized vitiligo. Clobetasol propionate (CP) is the most common topical agent possessing anti-inflammatory, antimitotic, antipruritic, and immunosuppressive properties that are employed in the management of plaque psoriasis. CP 0.025% cream was approved by the United States food and drug administration for the treatment of moderate-to-severe psoriasis in adult patients. The formulation is free from known contact allergens, such as propylene glycol, short-chain alcohols, and sorbitol-based emulsifiers, and has demonstrated hypoallergenic effects. High penetration of active ingredients and a lower degree of systemic absorption make CP 0.025% an effective and safe agent. This case series discusses the clinical experience of using CP 0.025% cream in various dermatologic conditions, focusing on its efficacy and safety.

scholarly journals Role of clobetasol propionate 0.025% topical therapy in various dermatoses

2021 ◽  
Author(s):  
Vishalakshi Vishwanath ◽  
Arvind Chaudhary ◽  
Ankit Agarwal ◽  
Bhukya Jyothi ◽  
C. Chitharanjan ◽  
...  
Keyword(s):  
Topical Therapy ◽  
Case Series ◽  
Serum Levels ◽  
Hand Eczema ◽  
Clobetasol Propionate ◽  
Cream Formulation ◽  
Chronic Hand Eczema ◽  
Therapeutic Benefits ◽  
Skin Conditions

The anti-inflammatory and vasoconstrictive properties of topical corticosteroids (TCs) contribute in providing therapeutic benefits in several skin conditions, including atopic eczema, localized vitiligo, psoriasis, and chronic hand eczema. Clobetasol propionate (CP) is the most common topical agent used for psoriasis management and demonstrates an efficacy superior to other TCs. A new CP 0.025% cream formulation has demonstrated hypoallergenic effects due to the absence of known contact allergens, such as propylene glycol, short-chain alcohols, and sorbitol-based emulsifiers. Lower CP serum levels and less hypothalamic–pituitary–adrenal axis suppression with CP 0.025% cream formulation than with CP 0.05% ensure better safety. The present case series discusses the clinical experience of using CP 0.025% cream in various dermatological conditions.

scholarly journals Role of Topical Corticosteroid Therapy in Various Dermatoses

2021 ◽  
Author(s):  
Jitendra Kishore Singh ◽  
Yogesh Rupram Zanwar ◽  
Jagannath Kumar ◽  
Jatin Jayeshbhai Patel ◽  
Vineet Chandrabhushan Dube ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Case Series ◽  
Immunosuppressive Agent ◽  
Systemic Absorption ◽  
Cream Formulation ◽  
High Penetration ◽  
United States Food ◽  
Chronic Skin ◽  
Us Fda ◽  
Chronic Skin Diseases

Topical corticosteroids are the cornerstone in managing several dermatologic disorders, including plaque psoriasis.Managing plaque psoriasis warrants the use of an effective anti-inflammatory, antimitotic, antipruritic, and immunosuppressive agent, such as clobetasol propionate (CP). Recently, CP 0.025% cream received approval by United States food and drug administration (US FDA) for the treatment of moderate-to-severe psoriasis in adult patients. CP 0.025% cream has proven efficacious in chronic skin diseases, including controlling inflammation and pruritus, in various steroid-responsive dermatoses. In contrast to prior CP formulations, this novel CP 0.025% cream formulation does not contain propylene glycol, short-chain alcohols, and sorbitol-based emulsifiers, which are known contact allergens. The other beneficial attributes of this CP 0.025% cream formulation are high penetration of active ingredients and a lower degree of systemic absorption. This case series discusses the experience of using CP 0.025% cream in terms of its efficacy and safety in various dermatologic conditions. 

scholarly journals Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations.

2010 ◽  
Vol 13 (1) ◽  
pp. 11 ◽  
Author(s):  
Wai Ling Au ◽  
Michael F Skinner ◽  
Isadore Kanfer
Keyword(s):  
Topical Corticosteroid ◽  
Human Skin ◽  
The United States ◽  
Clobetasol Propionate ◽  
Tape Stripping ◽  
Draft Guidance ◽  
Ointment Formulation ◽  
United States Food ◽  
Assay Methods ◽  
States Food

Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn. This was due to problems associated with the method and also inconsistencies and variability in the resulting data. The purpose of this study was to re-visit the tape stripping technique, incorporate refinements to reduce variability and validate the method using bioequivalence data obtained from the assessment of a topical corticosteroid cream containing 0.05% clobetasol propionate using the human skin-blanching assay. Methods: A pilot tape stripping study was conducted to establish the variability of the formulations.The bioequivalence of two different commercially available clobetasol propionate cream formulations and a clobetasol propionate ointment formulation were subsequently investigated using the tape stripping method. Results: The data from the pilot tape stripping study correlated well with data from the human skin-blanching assay. A subsequent pivotal tape stripping study confirmed bioequivalence between the two cream formulations whereas bio-inequivalence was demonstrated between the cream and ointment formulations.Conclusions: These studies show that the results from tape stripping concur with data from the human skin blanching assay and demonstrate the potential of a well-controlled tape stripping study as an option for the assessment of bioequivalence of topical corticosteroid formulations.

Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18790-e18790
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Arlene Yu ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Descriptive Analysis ◽  
Package Insert ◽  
Case Series ◽  
The United States ◽  
Chemotherapeutic Agents ◽  
United States Food ◽  
Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

scholarly journals Efficacy and safety of intralesional triamcinolone acetonide in the treatment of chronic hand eczema

2017 ◽  
Vol 10 (3) ◽  
pp. 129
Author(s):  
Tasnuva Ashraf ◽  
Harashit Kumar Paul ◽  
Md. Shahidullah Sikder ◽  
A. S. M. Zakaria ◽  
Saiful Islam Bhuiyan ◽  
...  
Keyword(s):  
Triamcinolone Acetonide ◽  
Severity Index ◽  
Hand Eczema ◽  
Clobetasol Propionate ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Chronic Hand Eczema ◽  
Group A ◽  
Group B

<p class="Abstract">This randomized controlled clinical trial was conducted to assess the efficacy and safety of intralesional triamcinolone acetonide in the treatment of chronic hand eczema comparing with topical clobetasol propionate. A total 60 patients of chronic hand eczema were recruited in the study. Thirty patients (Group A) were treated with intralesional triamcinolone acetonide and the rest 30 (Group B) with topical clobetasol propionate. Severity and improvement were assessed using Hand Eczema Severity Index (HECSI) score. The patients of both groups were followed up at 4<sup>th</sup> week and 12<sup>th</sup> week. In Group A, median HECSI score at baseline, 4<sup>th</sup> week and 12<sup>th</sup> week were 3, 20 and 20 respectively; whereas these scores were 54, 10 and 8 in Group B. In both groups, HECSI score was decreased gradually but the rate was higher in Group B than Group A (p&lt;0.05). Thinning of skin, an adverse effect, was seen in patients of both the intralesional triamcinolone acetonide (10%) and topical clobetasol propionate (16.7%) groups (p&gt;0.05). The result of this study demonstrates that intralesional triamcinolone acetonide is effective and safe in treating chronic hand eczema but less effective than the topical clobetasol.</p>

scholarly journals The Comparative Study of Atopic Dermatitis and Chronic Hand Eczema Clinical Course in Adults after Acute Relapse Treatment

2021 ◽  
pp. 373-379
Author(s):  
Aleksandruk Oleksandr Dmytrovych ◽  
Stepanenko Roman Leonidovich ◽  
Ali Mohammed ◽  
Stepanenko Viktor Ivanovich ◽  
Tetiana Konovalova ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Disease Severity ◽  
Hand Eczema ◽  
Skin Care ◽  
Adult Patients ◽  
Sample Population ◽  
Relapse Treatment ◽  
Chronic Hand Eczema ◽  
Acute Relapse ◽  
Anti Inflammatory

Aims: To evaluate Atopic dermatitis (AD) and Chronic hand eczema (CHE) course in adults after discontinuation of acute or sub acute relapse treatment. Study Design: three groups of adult patients that finished standard treatment for relapse of AD and CHE were followed up within 24 weeks of period to check disease severity, itch intensity and skin management effectiveness. Place and Duration of Study Sample: population of Ivano-Frankivsk region of Ukraine September 2015 – May 2021. Methods: 155 patients (51 females and 104 males; age between 20 and 50 years) with AD or CHE were enrolled in the study. The patients were randomized into three study groups depending on diagnosis. SCORAD index was used to assess disease severity, visual analog scale (VAS) was used to assess skin itch intensity. Frequency of disease treatment re-start with topical or systemic anti-inflammatory drugs as well as patients’sintention to ask for a treatment were calculated. Results: Results of our study have shown that cases of new disease worsening occured within nearest 24 weeks after AD and CHE aggravation treatment discontinuation and are quite frequent despite appropriate skin care. Conclusion: part of adult patients continues suffering from skin itch or mild skin lesions within nearest 24 weeks after discontinuation of intensive treatment of AD or CHE relapse. Prescription of antihistamines and/or topical anti-inflammatory treatment in addition to generally recommended skin care with emollients is crucial for patients with new worsening of the disease. Among patients with a new signs of worsening a part would unlikely ask for a new treatment immediately unless this worsening is moderate or severe.

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration

2020 ◽  
pp. 193864002094371
Author(s):  
Sreenivasulu Metikala ◽  
Karim Mahmoud ◽  
Kathryn M. O’Connor ◽  
Wen Chao ◽  
Keith L. Wapner ◽  
...  
Keyword(s):  
United States ◽  
Bone Erosion ◽  
Case Series ◽  
The United States ◽  
Hallux Rigidus ◽  
Mandatory Reporting ◽  
True Incidence ◽  
United States Food ◽  
States Food ◽  
Reporting Mechanism

Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration’s (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications. Levels of Evidence: Level IV: Case series from large database analysis

Clinical Characteristics of Patients Diagnosed with Strongyloidiasis in a United States Urban Outpatient Dermatology Department: A Case Series

2017 ◽  
Vol 1 (3) ◽  
pp. 156-160
Author(s):  
Jacqueline Watchmaker ◽  
Sean Legler ◽  
Dianne De Leon ◽  
Vanessa Pascoe ◽  
Robert Stavert
Keyword(s):  
United States ◽  
Case Series ◽  
The United States ◽  
Screening Tools ◽  
Dermatology Department ◽  
Cutaneous Manifestations ◽  
Serologic Testing ◽  
Patient Reported ◽  
History Of ◽  
Endemic Areas

Background: Although considered a tropical disease, strongyloidiasis may be encountered in non-endemic regions, primarily amongst immigrants and travelers from endemic areas.  Chronic strongyloides infection may be under-detected owing to its non-specific cutaneous presentation and the low sensitivity of commonly used screening tools. Methods: 18 consecutive patients with serologic evidence of strongyloides infestation who presented to a single urban, academic dermatology clinic between September 2013 and October 2016 were retrospectively included.  Patient age, sex, country of origin, strongyloides serology titer, absolute eosinophil count, presenting cutaneous manifestations, and patient reported subjective outcome of pruritus after treatment were obtained via chart review.  Results: Of the 18 patients, all had non-specific pruritic dermatoses, 36% had documented eosinophila and none were originally from the United States. A majority reported subjective improvement in their symptoms after treatment. Conclusion:  Strongyloides infection and serologic testing should be considered in patients living in non-endemic regions presenting with pruritic dermatoses and with a history of exposure to an endemic area.Key Points:Chronic strongyloidiasis can be encountered in non-endemic areas and clinical manifestations are variableEosinophilia was not a reliable indicator of chronic infection in this case series Dermatologists should consider serologic testing for strongyloidiasis in patients with a history of exposure and unexplained pruritus

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