BACKGROUND:Psoriasis has a large negative impact on quality of life and is associated with both depression and anxiety. The introduction of biologics has improved treatment outcomes, but the ways in which patients perceive these improvements are not well characterized.OBJECTIVES:To investigate the everyday life experiences of patients with psoriasis receiving biological treatment in order to gain an understanding of their needs and to improve the quality of care.METHODS:A qualitative narrative methodology was utilized. In total 48 h of participant observations during consultations, and 15 semistructured interviews, were conducted with patients receiving biological treatment. Data were analysed according to Ricoeur's theory of interpretation.RESULTS:Receiving biological treatment was experienced as a turning point, with a significant impact on physical, psychological and emotional levels. However, psychological consequences, such as isolation and social withdrawal, seemed to be a part of the patient's identity; the negative perceptions of psoriasis left marks behind that affected the patient's self-image. Perceived fear of discontinuation of the biological treatment resulted in insecurity, and patients were reluctant to initiate discussion about these concerns with healthcare professionals.CONCLUSIONS:Providing assistance when patients enter the transition of receiving biological treatment may be important. Patients' fear of biological treatment being discontinued is an ongoing issue that healthcare professionals could address.
Psoriasis is a common chronic inflammatory skin disease, affecting about 2‐4% of the population in Europe. Psoriasis negatively affects patients’ quality of life and is linked to several psoriasis‐associated comorbidities (diseases that occur alongside psoriasis). Topical drugs, which means they are applied directly to the skin, are a recommended first‐line treatment for mild‐to‐moderate psoriasis, but their reported real‐life use is conflicting. This study investigated psoriasis patients’ real‐life use of topical drugs and other antipsoriatic treatments. Danish researchers conducted a drug utilization study based on the nationwide Danish health registry data, including data on all patients above 18 years of age who received a first‐time hospital diagnosis of psoriasis and were prescribed at least one topical drug in the period 2005‐2015 (7,743 patients). The patients were followed for a three‐year period after the time of diagnosis. Among many findings, the authors reported that the most frequently used topical antipsoriatic drugs were combinations containing corticosteroid with calcipotriol, accounting for 31% of the total use. Patients’ use of topical drugs increased around the time of hospital diagnosis. The use also varied considerably between geographical regions as well as for the individual patients, with 25% of the patients using 70% of the total amount of topical treatment. The total use of topical antipsoriatic drugs decreased by 19% during the study period, while use of a drug called methotrexate which is taken by tablet or injection, increased by 70%. The authors concluded that the use of topical antipsoriatic drugs shows considerable diversity over time, regional practices and differences between patients.
银屑病是一种慢性炎症性皮肤病,在欧洲影响大约 2‐4% 的人群。银屑病对患者的生活质量产生不利影响,且与若干银屑病‐相关合并症(与银屑病同时发生的疾病)相关。局部外用药物意味着它们直接用在皮肤上,是轻中度银屑病的推荐一线治疗,但它们所报告的现实生活使用却是相矛盾的。此研究调查了银屑病患者对于局部外用药物和其他抗银屑病治疗的现实生活使用情况。丹麦研究者们基于全国范围的丹麦卫生注册数据进行了一项药物利用研究,这些数据包括所有在 2005‐2015 年间首次获得银屑病住院诊断且被开具至少一种局部外用药物的 18 岁以上患者(7,743 名患者)的数据。在诊断后对这些患者进行了 3 年随访。在众多发现中,作者们报告称,最频繁使用的局部外用抗银屑病药物是含有皮质类固醇和钙泊三醇的复方药物,占总使用量的 31%。患者在医院诊断前后的局部外用药物使用增多。使用量在地理区域以及个体患者之间也有显著差异,25% 患者使用了 70% 的总局部外用治疗量。抗银屑病局部外用药物的总使用量在此研究期间下降了 19%,同时,一种名为甲氨蝶呤的药物的使用(通过片剂或注射液形式使用)则增高了 70%。作者们得出结论,局部外用抗银屑病药物的使用在时间、地区实践和患者间差异方面显示出了相当高的多样性。
BACKGROUND:Adherence to topical psoriasis treatments is low, which leads to unsatisfactory treatment results. Smartphone applications (apps) for patient support exist but their potential to improve adherence has not been systematically evaluated.OBJECTIVES:To evaluate whether a study-specific app improves adherence and reduces psoriasis symptoms compared with standard treatment.METHODS:We conducted a randomized controlled trial (RCT, clinicaltrials.gov registration: NCT02858713). Patients received once-daily medication [calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam] and were randomized to no app (n = 66) or app intervention (n = 68) groups. In total, 122 patients (91%) completed the 22-week follow-up. The primary outcome was adherence, which was defined as medication applied ≥ 80% of days during the treatment period and assessed by a chip integrated into the medication dispenser. Secondary outcomes were psoriasis severity measured by the Lattice System Physician's Global Assessment (LS-PGA) and quality of life, measured using the Dermatology Life Quality Index (DLQI) at all visits.RESULTS:Intention-to-treat analyses using regression was performed. More patients in the intervention group were adherent to Cal/BD cutaneous foam than those in the nonintervention group at week 4 (65% vs. 38%, P = 0·004). The intervention group showed a greater LS-PGA reduction than the nonintervention group at week 4 (mean 1·86 vs. 1·46, P = 0·047). A similar effect was seen at weeks 8 and 26, although it did not reach statistical significance.CONCLUSIONS:This RCT demonstrates that the app improved short-term adherence to Cal/BD cutaneous foam treatment and psoriasis severity.
1 Dept. of Dermatology and Allergy Centre, Odense University Hospital, Odense, DK 2 Centre for Innovative Medical Technology (CIMT), Clinical Institute, University of Southern Denmark, Odense, DK 3 Odense Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark & Department of Clinical Research, University of Southern Denmark, Odense, DK 4 Dermatological Investigations Scandinavia, University of Southern Denmark, Odense, DK 5 Clinical Pharmacology and Pharmacy, Dept. of Public Health, University of Southern Denmark, Odense, DK 6 Hospital Pharmacy, Odense University Hospital, Odense, DK 7 Research Unit of User Perspectives, Dept. of Public Health, University of Southern Denmark, Odense, DK 8 LEO Pharma, Ballerup, DK 9 Dept. of Dermatology (Center for Dermatology Research), Wake Forest School of Medicine, Winston-Salem, USA
Background The reported real-life use of prescribed topical antipsoriatic drugs is conflicting and based on heterogeneous data sources. Objectives To describe the utilization of topical antipsoriatic drugs among patients with psoriasis in Denmark. Methods A drug utilization study was performed based on nationwide Danish health registry data. We identified patients who received a first-time hospital diagnosis of psoriasis and redeemed at least one topical drug prescription in the period 2005-2015 (n = 7743). Patients were followed for 3 years from the time of diagnosis. Use of topical and systemic antipsoriatic drugs was described, specified by the type of treatment. Results The total use of topical drugs was divided between corticosteroids with calcipotriol (31%), calcipotriol (6.5%), very potent corticosteroids (24%), potent corticosteroids (30%), moderate corticosteroids (7.2%) and corticosteroids with antimicrobials (1.6%). There was a 19% reduction in the overall use of topical drugs during the study period. Use increased around the time of diagnosis and the majority of patients redeemed more than two packages of topical drugs during the first year after being diagnosed. Regional differences in patients' use of topical drugs varied considerably. The distribution of use of topical drugs was uneven, with a minority of all patients (25%) using 70% of the total amount of topical treatment. There was a 70% increase in the use of methotrexate over the study period. Biologics were used by up to 6%. Conclusions The study provides further evidence that the use of topical antipsoriatic drugs shows considerable heterogeneity over time and regional practices, and differences between patients.
Psoriasis is a common chronic inflammatory skin disease which causes red, scaly plaques (patches of skin), often on the knees, elbows, scalp and trunk. Psoriasis can have a negative impact on patients’ quality of life, and additionally creates a ‘socioeconomic burden’ due to healthcare costs, time off work, etc. Topical calcipotriol with corticosteroids are a recommended first treatment of mild-to-moderate psoriasis, but many patients - for many different reasons - do not apply the creams or ointments as prescribed. This study investigated if the use of a patient-supporting applications for smartphones (apps) could improve patients' use of a topical (applied to the skin) drug (calcipotriol/betamethasone dipropionate combination in a cutaneous foam) and in addition reduce severity of psoriasis and improve quality of life short- and long-term. Danish dermatologists conducted a trial at a dermatology clinic at Odense University Hospital in Denmark. 134 patients were included and allocated to either use the drug (66 patients) or to use the drug together with support from an app (68 patients) for a 4-week period. The app provided once-daily compulsory treatment reminders and was also able to monitor if patients were using their medication, through an electronic-monitor chip mounted on top of the foam dispenser. The information was synchronized via Bluetooth® to the patient's smartphone. 91% of the patients returned for all follow-up visits during a half-year period. This controlled trial showed that patients using the app significantly improved use of the medication in the 4-week period and had a short-term reduction in severity of psoriasis. The authors concluded that apps have potential to improve psoriasis patients’ use of topical medications.
银屑病是一种常见慢性皮肤病,会导致红色鳞屑状斑块 (皮肤斑片), 通常位于膝部、肘部、头皮和躯干。银屑病可能对患者的生活质量造成负面影响, 并因医疗保健费用、误工等带来额外的“社会经济负担”。局部外用卡泊三醇和皮质类固醇是轻度至中度银屑病的推荐一线治疗, 但很多患者因众多不同原因并不按处方使用这些乳膏或软膏。这项研究调查了使用智能手机患者支持应用 (apps) 能否改善患者局部外用 (用于皮肤) 药物 (皮肤泡沫样卡泊三醇/丙酸倍他米松复方制剂) 的使用, 并额外降低银屑病的严重程度和改善短期和长期生活质量。丹麦皮肤科医生在丹麦 Odense 大学医院皮肤科进行了一项实验。纳入134 名患者, 这些患者被分配使用药物 (66 名患者) 或使用药物+来自 app 的支持 (68 名患者) 共计 4周。这种 app 每天提供一次强制治疗提醒, 还可以通过安装在泡沫给药器顶部的电子监测芯片监测患者是否正在使用他们的药物。通过蓝牙®将这些信息同步到患者的智能电话中。91% 患者在半年期间返回接受所有随访。这项对照试验显示, 使用此 app 的患者在 4 周期间的药物使用显著改善, 并短期减轻银屑病的严重程度。作者们得出结论说, 此 app 可能改善银屑病患者中局部外用药物的使用。 Linked Article:Svendsen et al. Br J Dermatol 2018; 179:1062–1071
BACKGROUND/PURPOSE:Alternatives to corticosteroids in the treatment of irritant contact dermatitis (ICD) are needed and may include glycerol and topical immunomodulators like tacrolimus. Because the efficacy of different treatments in experimentally induced ICD may vary depending on the irritant applied, we tested the efficacy of four anti-irritant compounds using the two different irritants sodium lauryl sulfate (SLS) and nonanoic acid (NON). METHODS:In a randomized, double-blind, controlled trial, healthy volunteers were exposed to 5% SLS and 50% NON (the right and the left forearm, respectively) in a cumulative wash test. Induction of ICD was obtained by three daily washings for 7 days, followed by a maintenance phase with two daily washings for 12 days. Treatment (triamcinolone acetonide, clobetasol propionate, tacrolimus and glycerol ointment) was started at day 7 and applied immediately after washing. Vehicle and no treatment served as the control. Reactions were evaluated clinically and instrumentally. RESULTS:No treatments were significantly better than the other treatments and controls. There was a tendency toward a dose-dependent response to corticoid treatment, and a trend toward worsened irritancy by tacrolimus on SLS-irritated skin. Explained variance in the experiment by anova revealed a very small effect of treatments compared with an immense and significant subject effect. CONCLUSION:No claims of effective anti-irritant properties for any of the ointments can be maintained. Application of the present wash test as a tool for anti-irritant efficacy testing may be complicated by the small observed variance explained by treatment.
Skin irritants may induce irritant contact dermatitis (ICD) in various ways but the end result remains the same: a clinical picture which in most cases is practically indistinguishable from allergic contact dermatitis (ACD). A treatment that works for ACD does not necessarily work for ICD. Management has to focus on preventive measures, education of people exposed to irritants and supportive topical treatment of varying nature depending on the clinical circumstances.
Background/purpose: Human in vivo cumulative irritation tests with low-grade irritants simulate real-life exposure to skin irritants. The test outcome depends not only on the substance tested but also on the design of the assay. More than one experimental irritant is usually used because chemicals have diverse mechanisms of action on the skin. We used sodium lauryl sulfate (SLS) and nonanoic acid (NON) in three different concentrations plus their vehicles, water and n-propanol, respectively, to validate our test models and to optimize test concentrations.Methods: Healthy volunteer forearm skin was exposed in two different cumulative test models: a repeated open model (ROAT) and an exaggerated wash test model. ROAT: 10-min daily exposures for 5+4 days (no irritation on weekend) to SLS 0% (water), 0.5%, 1.0% and 2.0% on the right arm and NON 0% (n-propanol neat), 10%, 20% and 30% on the left arm. Wash test: induction of irritation by three daily washings for 6 days and maintenance of the dermatitis by two daily washings for 12 days with SLS 0%, 5%, 10% and 15% or NON 0%, 30%, 40% and 50%. Reactions were evaluated clinically and instrumentally (transepidermal water loss, colorimetry and hydration) at sequential time points. Additionally, for the wash test, subjective pain scores were obtained from the volunteers.Results: In the ROAT, n-propanol exhibited irritation potential at the level of SLS 1.0% and, by visual scoring, was only found to be significantly different from the two highest concentrations of NON (20% and 30%). In the wash test, n-propanol was much less irritating than SLS, and it could only be distinguished statistically from NON (any concentration) by visual reading. For both test models, n-propanol, by instrumental measurements, was not significantly different from any NON concentration.Conclusion: In cumulative irritation test assays, n-propanol appears to be quite irritant itself and may thus be a significant contributor to NON irritation. Moreover, n-propanol was more irritant in the ROAT compared with the wash test.
BACKGROUND:The effect of six skin-care formulations (SCFs) on experimentally induced cumulative irritation was studied in hairless guinea-pigs (HLGPs) and in human volunteers (HVs). The formulations were a basic cream, a carbomer cream and four modifications of the carbomer cream, containing either 10% isopropyl palmitate (IPP cream), 10% glycerol (glycerol cream), 19.5% canola oil (canola oil cream) or 0.5% (-)-alpha-bisabolol (bisabolol cream).METHODS:In HLGP, irritant dermatitis was induced with 30 min daily exposure for 4 days to 0.5% sodium lauryl sulfate aq. (SLS). In HVs, irritant dermatitis was induced with 10 min daily exposure for 5+4 days (no irritation on weekends) to 3% SLS aq. on the right and 30% nonanoic acid (NON) in n-propanol on the left volar forearm. Clinical scoring was performed daily; evaporimetry (total epidermal water loss (TEWL)), hydration and colorimetry were measured at baseline (day 0) in the middle and at the end of treatment. Treatments were applied twice daily. The basic cream and the IPP cream were excluded from testing in HLGP because they were known from previous studies to be irritant in HLGP, while all formulations were known to be equally and well tolerated locally in humans.RESULTS:All formulations worsened the skin irritation in HLGP: the glycerol cream the least, the canola oil cream the most, while the bisabolol cream and the carbomer cream were indistinguishable. In humans, the glycerol cream was better than 'No Treatment' after cumulative irritation with both SLS and NON. The basic cream was better tolerated in humans than was expected from previous testing in HLGPs.CONCLUSION:In conclusion, the results from the studies in HLGPs and HVs are in agreement with regard to ranking of the SCFs. Further, the glycerol cream showed a positive treatment effect on both SLS- and NON-irritated skin in HVs.
Small rodent laboratory animals lack the complex cutaneous structure and function of human skin, resulting in "all or none'' responses to mild irritants so that the animals may show a less discriminative reaction pattern compared to human volunteers (HV). However, histological studies suggest that the skin of the hairless guinea pig (HLGP) is more similar to human skin than to the skin of haired guinea pigs and other rodents. We compared the tolerance pattern of six composite topical formulations with weak irritant potential in 20 human volunteers (HV) and in 15 male HLGPs. The skin care formulations (SCF), with and without either isopropyl palmitate, glycerol, canola oil, or (-)-alpha-bisabolol, were selected because they were known to cause a differentiated irritative response in HLGP. The HLGPs were treated twice a day on a 5 x 5 cm area on each flank with a SCF for four consecutive days. The irritant effects were quantified by clinical assessment, measurement of transepidermal water loss (TEWL), and colorimetry (a*-parameter). In humans the tolerability was evaluated clinically using the chamber scarification test. The ranking of the formulations was similar in the two models. However, HLGPs were statistically more sensitive to the formulations. Negative results in HLGPs are predictive of good tolerability in humans; however, positive results in the HLGPs do not necessarily indicate that a topical formulation cannot be used in humans.
Abrasive agents used as exfoliants in acne and xerotic skin conditions have been criticized for being double-edged swords that might create more skin damage than benefit due to exaggerated use. Paradoxically, it has been demonstrated that scrub creams may induce beneficial changes in human skin similar to treatment with topical tretinoin. In the present study, the efficacy of an aluminum-oxide-based scrub cream in combination with an α-hydroxy acid formulation was compared to the α-hydroxy acid formulation alone in 12 elderly female volunteers with itchy, xerotic leg skin. Following a 2-week washout period, the midportions of the lower lateral legs were treated with the combined treatment on one leg and with the α-hydroxy acid formulation on the other for 3 weeks. Clinical scoring, self-assessment as well as objective measurements of transepidermal water loss (TEWL) and hydration were performed at baseline and 3 days after the last treatment. In 3 volunteers, punch biopsies were obtained at the same time points. Both treatment strategies improved xerosis and pruritus, the combined treatment was statistically more effective. Hydration was not affected by the treatments, whereas TEWL was significantly reduced by both treatments, more so with the α-hydroxy acid formulation, indicating an improvement in barrier function. The clinical and instrumental findings were supported by histological findings following the combined treatment showing thickening of the epidermis and partial correction of epidermal atypia indicating increased epidermal proliferation. It appears that the combination treatment used in a controlled fashion has the potential for reversing some of the changes induced by photoaging. The changes induced are most likely due to unspecific mechanical stimulation of epidermal proliferation in combination with increased exfoliation.
Small rodent laboratory animals lack the complex cutaneous structure and function of human skin resulting in “all or none”‐responses to mild irritants so that the animals may show a less discriminative reaction pattern compared to human volunteers when studying the tolerability of topical drug formulations. This study compared the tolerance pattern of a 6 composite formulations (SCF A‐F) in human volunteers and in hairless guinea pigs (HLGP). The formulations were 2 basic creams (A and B) and 4 composite creams containing either isopropyl palmitate (C), glycerin (D), canola oil (E) or (‐)‐alfa‐bisabolol (F). The tolerability of 6 selected skin care formulations (SCF A‐F), known to cause a differentiated irritative response in HLGP, was studied in 15 male SGP and 20 human volunteers. The HLGP were treated twice a day on a 5 × 5 cm area on each flank with a SCF for 4 consecutive days. The irritant effects of the SCF were quantified by clinical assessment, measurement of trans epidermal waterloss (TEWL) and colorimetry (a*‐parameter). In humans the tolerability was evaluated clinically using the chamber scarification test. In HLGP SCF A and C were strong irritants followed closely by E, the remaining formulations were indistinguishable. In human volunteers all formulations were tolerated equally and well with the clinical score rising slightly on the first day and remaining stable thereafter. In conclusion, the HLGP appeared to be too sensitive, as formulations showing irritation in HLGP were well tolerated in a human.
Background: Xerosis, a well-known problem in the elderly part of the population, is often exacerbated in winter with negative effects on daily life. Objective: To describe differences in stratum corneum function of the lower legs in winter compared to summer using objective biometric methods. Methods: The following techniques were utilized: colorimetry, evaporimetry, laser Doppler perfusion imaging, sticky slides (D-Squames®) and corneometry. The reaction to a 24-hour patch test with sodium lauryl sulfate, burning to chloroform:methanol and the whealing response to dimethylsulfoxide were also studied. Results: In winter, the stratum corneum had a looser structure and a diminished barrier function with an increased neurosensory reactivity. Conclusion: The results suggest that the exacerbation of xerosis in the winter is accompanied by structural changes in the stratum corneum, making it looser and more permeable to chemical irritants with a heightened response to neurosensory stimuli.
BACKGROUND:Occupational exposure to Christmas cacti has been reported as a cause of type I allergy. Therefore, the prevalence of immediate-type mucosal and skin reactions related to cactus exposure was studied in 103 employees in a cactus nursery.METHODS:The study was based on a questionnaire followed by clinical examination, skin prick tests (SPT) with standard inhalant allergens and cacti, and a histamine-release test (HRT/Refix) using fresh cactus extracts as elicitor.RESULTS:The questionnaire was answered by 84 (82%) of the nursery employees, and 63 (61%) were interviewed and skin prick tested; 58 of these were tested with HRT/Refix. Furthermore, 22 healthy controls were included and tested in vivo and in vitro. Cactus-related contact urticaria and/or rhinoconjunctivitis were reported by 37% of the cactus workers. Based on a combination of positive history, positive SPT, and positive HRT/ Refix to cactus, 8% of the cactus workers were allergic to cacti. No noncactus workers or controls were allergic to cacti by these criteria. Testing with fresh cactus material elicited positive SPT and negative HRT/Refix in 27 nursery workers and controls, of whom 12 had immediate-type skin and mucosal symptoms.CONCLUSIONS:Christmas and Easter cacti seemed to be able to induce contact urticaria and rhinoconjunctivitis on both an immunologic and a nonimmunologic basis. Personal atopy was associated with positive reactions to cacti.