CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION

his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center.
Primary objective
Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use;
Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use.
Secondary objective
Evaluation of flares quantity and severity during 84 and 168 days of use;
Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days;
Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days;
Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days;
Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days;
Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days;
The folliculitis incidence after 14, 28, 84 and 168 days;
Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days;
Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days.
Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days.
Illustrative clinical pictures of one or two affected areas.

开始日期2021-12-20

申办/合作机构

Cosmetique Active International

NCT04179461 / Completed临床2期IIT

Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

开始日期2018-03-16

申办/合作机构

Children's Hospital & Medical Center

NCT00806221 / Completed临床2期IIT

An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis

The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

开始日期2006-11-01

申办/合作机构

Oregon Health & Science University

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100 项与泼尼卡酯相关的转化医学

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100 项与泼尼卡酯相关的专利（医药）

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179

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2024-03-01·EClinicalMedicine

Safety and efficacy of whole-body chlorhexidine gluconate cleansing with or without emollient in hospitalised neonates (NeoCHG): a multicentre, randomised, open-label, factorial pilot trial

Article

作者: Bielicki, Julia ; Islam, Mohammad Shahidul ; Azmery, Kazi Shammin ; LeBeau, Kristen ; O'Brien, Seamus ; Dramowski, Angela ; Schiavone, Francesca ; Bekker, Adrie ; Russell, Neal ; Walker, Ann Sarah ; Ellis, Sally ; Clements, Michelle N ; Skoutari, Peter ; Hoque, Mahbubul ; Fataar, Aaqilah ; Saha, Samir K ; Sharland, Michael ; Whitelaw, Andrew

Background:

Healthcare-associated infections account for substantial neonatal in-hospital mortality. Chlorhexidine gluconate (CHG) whole body skin application could reduce sepsis by lowering bacterial colonisation density, although safety and optimal application regimen is unclear. Emollients, including sunflower oil, may independently improve skin condition, thereby reducing sepsis. We aimed to inform which concentration and frequency of CHG, with or without emollient, would best balance safety and the surrogate marker of efficacy of reduction in bacterial colonisation, to be taken forward in a future pragmatic trial evaluating clinical outcomes of sepsis and mortality.

Methods:

In this multicentre, randomised, open-label, factorial pilot trial, neonates in two hospital sites (South Africa, Bangladesh) aged 1-6 days with gestational age ≥ 28 weeks and birthweight 1000-1999 g were randomly assigned in a factorial design stratified by site to three different concentrations of CHG (0.5%, 1%, and 2%), with or without emollient (sunflower oil) applied on working days vs alternate working days. A control arm received neither product. Caregivers were unblinded although laboratory staff were blinded to randomisation Co-primary outcomes were safety (change in neonatal skin condition score incorporating dryness, erythema, and skin breakdown) and efficacy in reducing bacterial colonisation density (change in total skin bacterial log₁₀ CFU from randomisation to day-3 and day-8). The trial is registered at the ISRCTN registry, ISRCTN 69836999.

Findings:

Between Apr 12 2021 and Jan 18 2022, 208 infants were randomised and 198 were included in the final analysis. Skin condition scores were low with mean 0.1 (sd = 0.3; N = 208) at baseline, 0.1 (sd = 0.3; N = 199) at day 3 and 0.1 (sd = 0.3; N = 189) at day 8, with no evidence of differences between concentration (1% CHG vs 0.5% estimate = -0.3, 95% CI = (-1.2, 0.6), p = 0.55. 2% CHG vs 0.5% CHG estimate = 0.5 (-0.4, 1.4), p = 0.30), increasing frequency (estimate = -0.4; 95% CI = (-1.1, 0.4), p = 0.33), emollient (estimate = -0.5, (-1.2, 0.3), p = 0.23) or with control (estimate = -0.9, (-2.3, 0.4), p = 0.18). Mean log₁₀ CFU was 4.9 (sd = 3.0; N = 208) at baseline, 6.3 (sd = 3.1; N = 198) at day 3 and 8.4 (sd = 2.6; N = 183) with no evidence of differences between concentration (1% CHG vs 0.5% estimate = -0.4; 95% CI = (-1.1, 0.23); p = 0.23. 2% CHG vs 0.5% CHG estimate = 0.0 (-0.6, 0.6), p = 0.96), with increasing frequency (estimate = -0.4; 95% CI = (-0.9, 0.2); p = 0.17), with emollient (estimate = 0.4, 95% CI = (-0.2, 0.9); p = 0.18) or with control (estimate = -0.2, 95% CI = (-1.3, 0.9); p = 0.73). By day-8, overall 158/183 (86%) of neonates were colonised with Enterobacterales, and 72/183 (39%) and 69/183 (9%) with Klebsiella spp resistant to third-generation cephalosporin and carbapenems, respectively. There were no CHG-related SAEs, emollient-related SAEs, grade 3 or 4 skin scores or grade 3 or 4 hypothermias.

Interpretation:

In this pilot trial of CHG with or without sunflower oil, no safety issues were identified, and further trials examining clinical outcomes are warranted. The relatively late start application of emollient, at a mean of 3.8 days of life, may have reduced the impact of the intervention although no subgroup effects were detected. There was no clear evidence in favour of a specific concentration of chlorhexidine, and there was rapid colonisation with Enterobacterales with frequent antimicrobial resistance, regardless of skin application regimen.

Funding:

The MRC Joint Applied Global Health award, the Global Antibiotic Research and Development Partnership (GARDP), MRC Clinical Trials Unit core funding (UKRI) and St. George's, University of London.

2024-01-01·Mycoses

Comparing emollient use with topical luliconazole (azole) in the maintenance of remission of chronic and recurrent dermatophytosis. An open‐label, randomized prospective active‐controlled non‐inferiority study

Article

作者: Pathania, Yashdeep Singh ; Kumar, Ashok ; Cds, Katoch

Abstract:

Background:

Literature on emollient use in the management of chronic and recurrent dermatophytosis is limited.

Objective:

To assess the efficacy of emollient in the remission maintenance of chronic and recurrent dermatophytosis.

Methods:

In this randomized open‐label study with the intention to treat, 80 patients with chronic recurrent dermatophytosis were randomized into two groups, where both groups were treated adequately for 6 weeks, followed by continuation of topical azole in group A and topical emollient in group B for 6 weeks. Clinical remission was determined by disappearance signs and symptoms of tinea lesions with or without hyperpigmentation. Physician and patient global assessment scores were evaluated every 2 weeks for 6 weeks to assess remission maintenance.

Results:

A total of 80 patients of chronic and recurrent dermatophytosis were assessed for remission maintenance. The recurrence of disease occurred in 20 patients overall, wherein 7 patients (17.5%) in group A and 13 patients (32.5%) in group B at the end of the study (18 weeks); however, the difference between the two groups was not statistically significant (p = .121). The mean physician global assessment scores of group A and group B at 12 weeks were 4.45 ± 0.74 and 4.15 ± 0.92, 4.43 ± 0.90 and 4.10 ± 0.98 at 14 weeks, 4.0 ± 1.32 and 3.98 ± 1.23 at 16 weeks, 3.85 ± 1.44 and 3.90 ± 1.35 at 18 weeks, respectively. The mean patient global assessment scores of group A and group B were 4.65 ± 0.62 and 4.25 ± 0.87 at 12 weeks, 4.40 ± 0.87 and 4.17 ± 0.98 at 14 weeks, 4.18 ± 1.15 and 4.12 ± 1.30 at 16 weeks and 3.97 ± 1.33 and 3.90 ± 1.51 at 18 weeks.

Conclusion:

The present study concludes that the efficacy of emollient was not inferior to topical luliconazole for maintaining remission in chronic and recurrent dermatophytosis.

2023-10-01·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

Emollients for preventing atopic eczema: Cost-effectiveness analysis of the BEEP trial.

Article

作者: Sach, Tracey H ; Haines, Rachel H ; Cork, Mike J ; Lartey, Stella T ; Jay, Nicola ; Thomas, Kim S ; Mitchell, Eleanor ; Bradshaw, Lucy E ; Ridd, Matthew J ; Perkin, Michael R ; Wyatt, Laura ; Montgomery, Alan A ; Boyle, Robert J ; Lawton, Sandra ; Kelleher, Maeve M ; Chalmers, Joanne R ; Davies, Charlotte ; Davies-Jones, Susan ; Williams, Hywel C ; Tarr, Stella ; Brown, Sara J ; Swinden, Richard ; Flohr, Carsten

BACKGROUND:

Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy.

OBJECTIVE:

To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis.

METHODS:

A within-trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost-effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost-effectiveness analysis. Secondary analysis, undertaken as a cost-utility analysis, reports incremental cost per Quality-Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU-9D at 2 years.

RESULTS:

At 2 years, the adjusted incremental cost was £87.45 (95% CI -54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI -0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI -0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, -£106.89 (95% CI -354.66, 140.88) and the proportion without eczema was -0.0329 (95% CI -0.0659, 0.0002). The 5-year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group.

CONCLUSIONS:

In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high-risk children does not appear cost-effective.

100 项与泼尼卡酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05601	泼尼卡酯	D07AC18	DB01130

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适应症	国家/地区	公司	日期
皮肤疾病	美国	Bausch Health Cos., Inc.	1991-09-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04179461 (CTgov)	临床2期	儿童哮喘	21	antihistamine+emollient cream+Azithromycin+Fluticasone Propionate+Cholecalciferol	廠襯鏇夢繭醖衊廠鏇製(醖鏇鹽淵觸鹽遞艱蓋積) = 餘憲製網膚膚憲蓋憲壓獵網廠觸構選鏇蓋願廠 (廠遞願襯膚襯淵醖夢鹹, 齋製構醖觸鹽餘衊膚鏇 ~ 艱鑰淵夢鹽選壓鬱顧鏇) 更多	-	2021-08-20
NCT00806221 (CTgov)	临床2期	特应性皮炎	22	emollient (Cetaphil cream)	觸壓壓簾範壓鏇鹹築鑰(鹽醖蓋襯繭醖夢鏇壓淵) = 選簾鏇顧糧蓋膚選餘遞糧艱構網鹹窪廠製衊廠 (選淵積窪淵築齋積淵鹽, 獵餘獵膚艱襯顧廠製糧 ~ 鑰齋餘鹹窪願選衊鹹繭) 更多	-	2017-07-11