scholarly journals Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kristin Helene Skullerud ◽  
Petter Gjersvik ◽  
Are Hugo Pripp ◽  
Erik Qvigstad ◽  
Anne Lise Ording Helgesen
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Lichen Planus ◽  
Global Assessment ◽  
Skin Diseases ◽  
Inflammatory Skin Diseases ◽  
Erosive Lichen Planus ◽  
The Mean ◽  
Inflammatory Skin

Abstract Background Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial. Methods We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1–6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted. Discussion The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis. Trial registration ClinicalTrials.govNCT0365666. Registered on 4 September 2018.

scholarly journals Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness

2015 ◽  
Vol 19 (86) ◽  
pp. 1-176 ◽  
Author(s):  
Karen Pickett ◽  
Emma Loveman ◽  
Neelam Kalita ◽  
Geoff K Frampton ◽  
Jeremy Jones
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Skin Diseases ◽  
Clinical Effectiveness ◽  
Educational Interventions ◽  
Inflammatory Skin Diseases ◽  
Inflammatory Skin ◽  
Skin Conditions ◽  
Effectiveness Studies

BackgroundInflammatory skin diseases include a broad range of disorders. For some people, these conditions lead to psychological comorbidities and reduced quality of life (QoL). Patient education is recommended in the management of these conditions and may improve QoL.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of educational interventions to improve health-related quality of life (HRQoL) in people with chronic inflammatory skin diseases.Data sourcesTwelve electronic bibliographic databases, including The Cochrane Library, MEDLINE and EMBASE, were searched to July 2014. Bibliographies of retrieved papers were searched and an Advisory Group contacted.Review methodsSystematic reviews were conducted following standard methodologies. Clinical effectiveness studies were included if they were undertaken in people with a chronic inflammatory skin condition. Educational interventions that aimed to, or could, improve HRQoL were eligible. Studies were required to measure HRQoL, and other outcomes such as disease severity were also included. Randomised controlled trials (RCTs) or controlled clinical trials were eligible. For the review of cost-effectiveness, studies were eligible if they were full economic evaluations, cost–consequence or cost analyses.ResultsSeven RCTs were included in the review of clinical effectiveness. Two RCTs focused on children with eczema and their carers. Five RCTs were in adults. Of these, two were of people with psoriasis, one was of people with acne and two were of people with a range of conditions. There were few similarities in the interventions (e.g. the delivery mode, the topics covered, the duration of the education), which precluded any quantitative synthesis. Follow-up ranged from 4 weeks to 12 months, samples sizes were generally small and, overall, the study quality was poor. There appeared to be positive effects on HRQoL in participants with psoriasis in one trial, but no difference between groups in another trial in which participants had less severe psoriasis. Carers of children in one RCT of eczema showed improvement in HRQoL; however, in a RCT evaluating a website intervention there were no demonstrable effects on HRQoL. Neither the RCT in those adults with acne nor the RCT in those adults with mixed skin conditions demonstrated an effect on HRQoL. One RCT reported subgroups with atopic dermatitis or psoriasis and education was effective for psoriasis only. Other outcomes also showed mixed results. It is unclear how clinically meaningful any of the observed improvements are. Three studies of cost-effectiveness were included. The interventions, comparators and populations varied across the studies and, overall, the studies provided limited information on cost-effectiveness. The studies did provide detailed information on resources and costs that could be useful to inform a future cost-effectiveness evaluation in this area.LimitationsThe application of the inclusion criterion around whether the interventions were aimed at improving HRQoL or the inference that they could improve HRQoL was difficult as information was rarely reported.ConclusionsThere is uncertainty regarding whether educational interventions addressing issues that could improve HRQoL in people with chronic skin conditions are effective. Tentative conclusions about the best approach to delivering these kinds of interventions are that face-to-face, group, sessions may be beneficial; however, text messages may also be effective. Delivery over a period of time and by a multidisciplinary team may also be associated with positive outcomes. There is uncertainty over whether or not educational interventions are cost-effective.Study registrationThis study is registered as PROSPERO CRD42014007426.FundingThe National Institute for Health Research Health Technology Assessment programme.

Quality of life measurement in chronic wounds and inflammatory skin diseases: Definitions, standards and instruments

2014 ◽  
Vol 5 ◽  
pp. 29-38 ◽  
Author(s):  
Matthias Augustin ◽  
Anna K. Langenbruch ◽  
Katharina Herberger ◽  
Katrin Baade ◽  
Lisa Goepel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Wounds ◽  
Skin Diseases ◽  
Inflammatory Skin Diseases ◽  
Life Measurement ◽  
Inflammatory Skin ◽  
Quality Of Life Measurement

scholarly journals Intravesical Instillation of Sodium Hyaluronate (Cystistat®) for the Treatment of Patients with Radiation Cystitis-Randomized Clinical Trial

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
Farzad Allameh ◽  
Abbas Basiri ◽  
Saleh Ghiasy ◽  
Atefeh Javadi ◽  
Seyyed Ali Hojjati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Sodium Hyaluronate ◽  
Intravesical Instillation ◽  
Control Group ◽  
Radiation Cystitis ◽  
Vas Score ◽  
The Mean

Background: Radiotherapy (RT) is a choice to manage pelvic organ malignancies that can affect bladder; therefore, it causes radiation cystitis with some bothering urinary symptoms and decreasing the patient’s quality of life. Intravesical hyaluronic acid (HA) is an agent with promising results in some studies for cystitis, and Cystistat is a derivative of hyaluronic acid. Objectives: This clinical trial aimed at evaluating the effects of intravesical instillation of Cystistat on symptoms of radiation cystitis and quality of life (QOL). Methods: A total of 58 patients with radiation cystitis were randomized in 2 groups (case: 30, control: 28). One group received intravesical Cystistat, the other received normal saline weekly for up to 4 weeks and then monthly for up to 2 months. Hematuria, Visual Analog scale (VAS) and QOL based on King’s Health questionnaire were compared before and 3, 6 and 9 months after intravesical instillation. Results: The mean age of the patients was 63.93 ± 10.89 years old. The mean of each sub-category of QOL and total score of QOL, as well as, VAS score were significantly improved in comparison to the control group at each time of follow-ups (P < 0.05). Hematuria was significantly different in the 3rd, 6th and 9th month of follow-ups (P < 0.05). Conclusions: Findings showed that patients with radiation cystitis could significantly benefit from intravesical instillation of HA, their hematuria would be successfully resolved rather than control group in addition to lowering the VAS score, so their QOL would be improved.

scholarly journals Maximizing the Utility of Transcriptomics Data in Inflammatory Skin Diseases

2021 ◽  
Vol 12 ◽  
Author(s):  
Jingni Wu ◽  
Zhixiao Fang ◽  
Teng Liu ◽  
Wei Hu ◽  
Yangjun Wu ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Life Quality ◽  
Treatment Strategies ◽  
Cutaneous Lesions ◽  
Inflammatory Skin Diseases ◽  
Transcriptomic Profiling ◽  
Transcriptomics Data ◽  
Host Defense System ◽  
Inflammatory Skin

Inflammatory skin diseases are induced by disorders of the host defense system of the skin, which is composed of a barrier, innate and acquired immunity, as well as the cutaneous microbiome. These disorders are characterized by recurrent cutaneous lesions and intense itch, which seriously affecting life quality of people across all ages and ethnicities. To elucidate molecular factors for typical inflammatory skin diseases (such as psoriasis and atopic dermatitis), transcriptomic profiling assays have been largely performed. Additionally, single-cell RNA sequencing (scRNA-seq) as well as spatial transcriptomic profiling have revealed multiple potential translational targets and offered guides to improve diagnosis and treatment strategies for inflammatory skin diseases. High-throughput transcriptomics data has shown unprecedented power to disclose the complex pathophysiology of inflammatory skin diseases. Here, we will summarize discoveries from transcriptomics data and discuss how to maximize the transcriptomics data to propel the development of diagnostic biomarkers and therapeutic targets in inflammatory skin diseases.

scholarly journals Investigating the effect of multimedia education in combination with teach-back method on quality of life and cardiac anxiety in patients with heart failure: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fateme Mohammadi ◽  
Mitra Sadeghi Jahromi ◽  
Mostafa Bijani ◽  
Shanaz Karimi ◽  
Azizallah Dehghan
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Trial ◽  
Educational Intervention ◽  
Educational Method ◽  
Cardiac Anxiety ◽  
Multimedia Education ◽  
Patients With Heart Failure ◽  
The Mean

Abstract Background Education can contribute to promotion of the quality of life and reduction of heart anxiety in patients with heart failure, so it is important to find a suitable educational method for these patients. Therefore, the present study was an attempt to determine the effect of multimedia education using teach-back method on the life quality and cardiac anxiety in patients with heart failure. Methods The present study was a randomized clinical trial. 120 patients with heart failure class I to III and aged less than 60 years old were selected using sequential sampling; then, they were assigned randomly into two intervention groups and one control group. Group A (multimedia education), group B (education using multimedia together with teach-back method), and group C (control). The quality of life and cardiac anxiety were evaluated in the participants of the three groups before, after, 1 month, and 3 months after the intervention. Data were analyzed using descriptive tests, Pearson correlation, Kolmogorov–Smirnov, chi square and ANOVA test in SPSS 22. The significance level was set at P < 0.05. Results No significant differences were found in the mean scores of the quality of life and cardiac anxiety in the control and two intervention groups before the educational intervention. However, immediately after, 1 month and 3 months after the educational intervention, a significant difference was observed between the mean scores of the quality of life and cardiac anxiety in the intervention groups (P < 0.05). Conclusion Multimedia education together with Teach-Back method is effective in promoting the quality of life and reducing cardiac anxiety in patients with heart failure. Therefore, it is recommended that health policymakers should use this educational method in providing treatment programs. Iranian Registry of Clinical Trials 20190917044802N1. Registration date: 5/2/2020.

scholarly journals The Effectiveness of Melissa Officinalis L. versus Citalopram on Quality of Life of Menopausal Women with Sleep Disorder: A Randomized Double-Blind Clinical Trial

2021 ◽  
Author(s):  
Mahboobeh Shirazi ◽  
Mohamad Naser Jalalian ◽  
Masoumeh Abed ◽  
Marjan Ghaemi
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Sleep Disturbance ◽  
Postmenopausal Women ◽  
Melissa Officinalis ◽  
Foeniculum Vulgare ◽  
Double Blind ◽  
Menopausal Women ◽  
The Mean

Abstract Objective The present study aimed to assess the effect of Melissa Officinalis L. (a combination of lemon balm with fennel fruit extract) compared with citalopram and placebo on the quality of life of postmenopausal women with sleep disturbance. Methods The present study is a randomized, double-blind, placebo clinical trial among 60 postmenopausal women with sleep disturbance who were referred to a university hospital from 2017 to 2019. The participants were randomized to receive M. Officinalis L. (500 mg daily), citalopram (30 mg) or placebo once daily for 8 weeks. The Menopause-Specific Quality of Life (MENQOL) questionnaire was self-completed by each participant at baseline and after 8 weeks of the intervention and was compared between groups. Results The mean for all MENQOL domain scores were significantly improved in the M. Officinalis L. group compared with citalopram and placebo (p < 0.001). The mean ± standard deviation (SD) after 8 weeks in the M. Officinalis L., citalopram and placebo groups was 2.2 ± 0.84 versus 0.56 ± 0.58 versus 0.36 ± 0.55 in the vasomotor (p < 0.001), 1.02 ± 0.6 versus 0.28 ± 0.2 versus 0.17 ± 0.1 in the psychomotor-social (p < 0.001), 0.76 ± 0.4 versus 0.25 ± 0.1 versus 0.11 ± 0.1 in the physical and 2.3 ± 1.0 versus 0.35 ± 0.5 versus 0.41 ± 0.5 in the sexual domain, respectively. Conclusions The results revealed that M. Officinalis L. may be recommended for improving the quality of life of menopausal women with sleep disturbance. Trial registration The present study was registered by the name “Comparison of the efficacy of citalopram and compound of Asperugo procumbens and foeniculum vulgare in treatment of menopausal disorders” with the code IRCT2013072714174N1 in the Iranian Registry of Clinical Trials (IRCT).

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

A randomized controlled clinical trial comparing different numbers of acupuncture sessions for migraine

2021 ◽  
pp. 096452842110560
Author(s):  
Thanan Supasiri ◽  
Chanchai Jariengprasert ◽  
Mayuri Phithaksilp ◽  
Puritat Sangtongpanichakul ◽  
Suchada Anotayanonth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Rating Scale ◽  
Acupuncture Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Open Label ◽  
Randomized Controlled ◽  
The Mean

Background: Acupuncture has shown benefit in preventing migraine attacks, but there has been no clear recommendation about the number of treatment sessions that should be provided. Objectives: The aim of this study was to examine whether 5 sessions of acupuncture treatment is non-inferior to 10 sessions for migraine. Methods: We performed a multicenter, open-label, randomized, controlled clinical trial across five hospitals in Thailand. Migraine patients were randomly assigned into two groups: treatment with 5 sessions of acupuncture (group A) or 10 sessions of acupuncture (group B). Acupuncture was performed twice a week. We measured the number of migraine days, average pain severity according to a 0–10 numeric pain rating scale (NPRS) and quality of life using the EQ-5D-5L questionnaire, comparing 4 weeks after treatment versus baseline. Results: Of 156 patients, 83 and 73 patients were assigned to groups A and B, respectively. Comparing 4 weeks after treatment with baseline, the mean reduction in the number of headache days in groups A and B was 6.4 (95% confidence interval [CI] 4.8 to 7.9) days and 6.4 (95% CI 4.5 to 8.4) days, respectively (p = 0.97). The mean difference between the reduction in headache days of the two groups was −0.1 (95% CI −2.5 to 2.4) days, which included the pre-specified non-inferiority limit of −1. The mean reduction of NPRS scores in groups A and B was 4.5 (95% CI 3.8 to 5.1) and 3.8 (95% CI 3.1 to 4.5), respectively (p = 0.17). Both groups showed an improvement in quality of life. Conclusion: Both 5 and 10 sessions of acupuncture were associated with apparent benefits in terms of preventing migraine attacks, reducing the severity of the headache and improving quality of life, based on comparisons between baseline and follow-up in both study groups. Although we were unable to demonstrate non-inferiority of 5 sessions versus 10 sessions of acupuncture, the effects in the two groups were not significantly different and the temporal effects appeared to last for at least 1 month. Trial registration number: TCTR20170612002 (Thai Clinical Trials Registry).

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