investigator global assessment
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2020 ◽  
Vol 1 (5) ◽  
pp. 01-04
Author(s):  
Gagik Hakobyan ◽  
Irina Komissarova ◽  
Zoya Evsyukova ◽  
Elena Ribakova ◽  
Armen Haruthyunyan

Objectives: The aim of the study was to assess the efficacy of 5% hyaluronic acid crem for the treatment of seborrheic dermatitis of the face. Materials and methods: A total of 49 patients (28 men and 21 women, age from 31 to 64 years) with seborrheic dermatitis of the face were selected for the study. A single-site, prospective observational study of 5% hyaluronic acid cream for the treatment of facial seborrheic dermatitis was conducted from 2016 to 2020. All patients underwent a thorough clinical examination according to the generally accepted scheme. Treatment planning includes a thorough history and physical examination, preoperative laboratory examination. At each visit, degrees of scale, erythema, and pruritus were evaluated. To assess the effectiveness of patients were given a questionnaire to fill out the questions. The questionnaire evaluated the 5% hyaluronic acid crem effectiveness of the treatment. Outcome was the evolution of the Investigator Global Assessment (IGA) scale, assessing erythema, scale / scaling, seborrhea and pruritus, all measured on a five-point scale, from 0: no signs / symptoms to 4: very severe sign / symptom. Subjects were assessed at baseline after 4 and 8 weeks. Results: Baseline IGA scores (mean ± SD) were 9 ± 3 (range: 5-13). The use of the EDS significantly reduced the IGA score by 67% at 4 week and by 83% at 8 week. The condition improved from baseline in 92.3% of subjects. Conclusion: 5% hyaluronic acid crem has been effective in reducing erythema, scales, seborrhea, and itching. No local side effects were reported.


2020 ◽  
Vol 9 (4) ◽  
pp. 1241
Author(s):  
Tamara Quint ◽  
Patrick M. Brunner ◽  
Christoph Sinz ◽  
Irene Steiner ◽  
Robin Ristl ◽  
...  

Dupilumab is the first biological treatment approved for moderate-to-severe atopic dermatitis (AD). Efficacy and safety have been demonstrated in clinical trials, but real-life data is still limited. The objective of this study was to retrospectively evaluate Dupilumab treatment in AD patients in a real-life clinical setting. Effectiveness and safety outcomes were collected at baseline and after 2, 6, 10, 24, 39, and 52 weeks by using clinical scores for disease activity, as well as serological markers. Ninety-four patients from five dermatological hospitals were included. After 24 weeks of treatment, the median Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI) showed a significant reduction compared to baseline (3.9 ± 0.7 vs. 1.4 ± 0.8 and 26.5 ± 12.5 vs. 6.4 ± 6.5). Interestingly, we observed rosacea-like folliculitis as an unexpected side effect in 6.4% of patients. Dupilumab proves to be an effective and well-tolerated treatment under real-life conditions. The occurrence of rosacea-like folliculitis warrants further mechanistic investigation.


2020 ◽  
Author(s):  
Sandra P Smieszek ◽  
Bartlomiej Przychodzen ◽  
Sarah E Welsh ◽  
Jennifer Brzezynski ◽  
Alyssa Kaden ◽  
...  

ABTRACTBackgroundAtopic dermatitis (AD) is a heritable and heterogeneous inflammatory chronic skin disorder. Utilizing decision tree/supervised learning of extensive clinical, molecular and genetic data, we aimed to define distinct AD endotypes.MethodsDeep phenotyping and whole-genome sequencing was performed on samples obtained from participants of EPIONE, a randomized-controlled phase III study in AD patients with severe pruritus comprising mild (23%), moderate (64%) and severe (13%) AD as determined by AD Investigator Global Assessment scale. Three categories of analysis were performed: clinical associations, lab value associations (EOS, IgE, cytokines) and genetic analysis of whole-genome sequencing dataResultsBased on a decision tree, we found that five clinical features from the SCORing Atopic Dermatitis (SCORAD) Index can accurately differentiate between IGA severities. We observe a significant difference between severity and eosinophil counts (p<0.001), IgE (p<0.001) and Filaggrin (FLG) LOF frequency (OR 2.3, CI 1.6-3.2, p<0.0001) as well as interleukin pathway genes, specifically IL5RA variants differentiating the groups.ConclusionOur results suggest significant differences between severity groups across a number of features appear to constitute distinct endotypes with likely distinct causative factors. Differing underlying pathophysiology’s indicate endotype knowledge is critical to help guide therapeutic approaches to AD.Capsule summaryAD is a heritable and heterogeneous skin disorder that makes the ‘one size fits all’ therapeutic approach suboptimal for patients with AD.We attempted to define AD endotypes based on clinical, molecular, and genetic characteristics. Clinical, CBC, and genetic associations all tend to suggest existence of separate endotypes.


2020 ◽  
Vol 8 ◽  
pp. 2050313X2094045
Author(s):  
Ho Seung Kim ◽  
Jensen Yeung

A 36-year-old Caucasian female with a long history of atopic dermatitis presented with multiple flares eventually leading to dupilumab therapy. Five months into the dupilumab therapy, she presented with well-demarcated erythematous plaques with silvery scale resembling psoriasis on her knees and shins (body surface area 2%, Psoriasis Area Severity Index 1.6, Investigator’ Global Assessment 2). Biopsies were taken to confirm the diagnosis of classic psoriasis. Dupilumab was continued for another month while using clobetasol 0.05% ointment. The patient reported poor adherence to clobetasol therapy, and the lesions persisted. When dupilumab was discontinued, her psoriasis resolved over 6 weeks, but her atopic dermatitis returned. Dupilumab was restarted for atopic dermatitis management, and her psoriasis returned. There appears to be a rare causal association between dupilumab and psoriasis in this case. The mechanism of the drug reaction is yet to be discovered.


Author(s):  
Zoe Diana Draelos ◽  
Joseph F Fowler ◽  
Raymond Cornelison

Importance: Topical corticosteroids continue to play an important role in therapy for individuals with moderate-to-severe psoriasis, particularly in cases where systemic therapy is contraindicated or in which combination topical-systemic therapy is needed to achieve desired results. Although super-high-potency corticosteroids such as clobetasol propionate have the potential to produce desired results, side effects related to systemic absorption may limit their clinical utility. Objectives: To evaluate the potential of a new, lower-concentration clobetasol propionate cream 0. 025% (Impoyz Cream, [IMP]) to suppress the hypothalamic-pituitary-adrenal (HPA) axis as compared to clobetasol propionate, 0.05% cream (Temovate Cream, [TMV]) under maximal use conditions in patients with moderate-to-severe plaque psoriasis. To compare the plasma concentrations of clobetasol propionate before and after 2 weeks of topical treatment with either IMP Cream or TMV Cream under maximal use conditions.Design, Setting, and Participants: Randomized, multi-center, open-label study conducted across 15 clinical sites in the United States. Eligible subjects were males or females, at least 18 years old, with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis that involved 20% to 50% of the body surface area (BSA). 50 patients with an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at Baseline were randomized (1:1) to twice daily treatment with either IMP Cream or TMV Cream for 15 consecutive days.Main Outcomes and Measures: Primary safety assessments included hypothalamic-pituitary-adrenal axis suppression (as measured by ACTH stimulation test) and systemic drug absorption (as measured by plasma clobetasol propionate levels drawn at baseline and on Day 15 of treatment at 0, 1, 3, and 6 hours after final study product application). Secondary safety assessments included serum DHEAS at Days 8 and 15 and local cutaneous adverse events. The primary efficacy assessment was Investigator Global Assessment (IGA) score, measured at Days 8 and 15 of treatment.Results: Upon conclusion of the treatment period, the mean serum concentration of clobetasol propionate was significantly lower in the IMP Cream group vs the TMV group (56.3 vs 152.5 pg/mL, p=0.014). A lower proportion of subjects in the IMP group experienced HPA-axis suppression compared to the TMV group, although this did not reach statistical significance (12.5% vs 36.4%, p=0.086).  In terms of efficacy, the two treatment groups displayed similar marked improvement in psoriasis severity after 15 days of treatment, with 50% of the subjects in each group having an IGA score of 2 (mild) and 16.7% in the IMP group and 18.1% in the TMV group having a score of 0 or 1 (none or minimal). Conclusions and Relevance: Subjects with moderate-to-severe plaque psoriasis treated with a 15 day course of IMP Cream demonstrate lower levels of plasma clobetasol propionate than those treated with TMV, suggesting lower levels of systemic corticosteroid exposure with IMP versus those with TMV. Additionally, in this sample, topical therapy with IMP was associated with a trend towards a lower incidence of HPA axis suppression than TMV without comprising efficacy. Trial Registration: Registered 6 May, 2014.


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