Aim: To evaluate health-related quality of life (HRQoL) in cemiplimab-treated patients with locally advanced basal cell carcinoma (laBCC).Materials & methods: Eighty-four patients with laBCC received cemiplimab 350 mg every 3 weeks (up to 9 cycles). HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and each cycle. Mixed-effects repeated-measures models evaluated change from baseline across cycles.Results: Clinically meaningful improvement or maintenance was reported by 62-90% of patients on QLQ-C30 scales and by approximately 80% on Skindex-16 scales at Cycle 2, with consistent results at Cycle 9 except fatigue.Conclusion: Most cemiplimab-treated patients with laBCC reported improvement or maintenance of HRQoL with low symptom burden except fatigue.Clinical Trial Registration: ClinicalTrials.gov identifier NCT03132636, registered 28 April 2017.
Locally advanced basal cell carcinoma (laBCC) is a type of skin cancer that has the potential to invade surrounding tissues including bone, cartilage, nerve and muscle. Cemiplimab-rwlc is approved in the US for patients with laBCC following a therapy called hedgehog inhibitor (HHI) treatment or for whom HHIs are not appropriate. In a Phase II clinical trial, intravenous (in the vein) cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with laBCC who progressed on or were intolerant to HHIs.This analysis evaluated health-related quality of life, symptom burden, emotions and functional status in these patients using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires. Baseline scores (scores at the start of the clinical trial) showed moderate to high levels of functioning and low symptom burden that, except for fatigue, were maintained or improved over the course of cemiplimab treatment. These results show that despite the presence of fatigue, health-related quality of life and functional status were maintained with cemiplimab across the study duration.

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Patient-reported outcome measures (PROMs) capture disease severity metrics from the patient\'s perspective, including health-related quality of life (HRQL). Disease-specific validation of PROMs improves their clinical utility. We evaluated construct validity (HRQL) for Skindex-16 in routinely seen psoriasis patients and characterized instances of discordance between Skindex-16 scores and clinician-reported outcome measure of disease severity. We retrospectively studied psoriasis patients seen by University of Utah Dermatology from 2016 to 2020. Cross-sectional construct validity was assessed using quantile regression and Spearman correlation between overall physician global assessment (OPGA) score and Skindex-16 scores. Longitudinal within-subject correlation was performed using linear mixed models. Discordance (10th percentile or lower OPGA and 90th percentile or higher Skindex-16 score [clear skin, poor HRQL; cspHRQL] or the reverse [severe skin, good HRQL; ssgHRQL]) was characterized descriptively. 681 first-visit patients with psoriasis were included. Median overall Skindex-16 score varied by ≥ 10 points across all levels of OPGA scores. OPGA and Skindex-16 domain scores were moderately correlated (emotions ρ = 0.54, functioning ρ = 0.47, and symptoms ρ = 53). Longitudinal correlations were similar (emotion ρxy = 0.54, functioning ρxy = 0.65, symptoms ρxy = 0.47). Visits with cspHRQL discordance occurred for each Skindex-16 domain (emotions = 7, functioning = 13, symptoms = 12). The ssgHRQL group was observed within the emotions (n = 1) and functioning (n = 23) domains. Median Skindex-16 scores are different between different levels of OPGA and show moderate cross-sectional and longitudinal correlation. This supports construct validity in patients with psoriasis. Severe discordance was rare and most often for those with clear skin but poor HRQL. These discordances can prompt further patient-clinician conversation.

Skin conditions often considerably impact the older patients\' psycho-social health and quality of life (QoL). The present study was aimed to examine the validity and reliability of the Persian version of Skindex-16 among older people with skin diseases.
In this validation study, 260 older patients suffering from a range of skin conditions were recruited from a dermatology clinic in Rasht, Iran. Data were collected using a checklist for demographic and clinical characteristics and the Skindex-16 questionnaire. In this study, validity (face, content, and construct) and reliability (Cronbach\'s alpha) of the Skindex-16 were assessed and reported.
The mean age of participants was 64.51 ± 5.04 years. The results of confirmatory factor analysis showed that the model had acceptable fitness into the expected three-factor structure [χ 2 /df = 249.363, P < 0.001; GFI = 0.961; TLI =0.952; RMSEA = 0.078 (90% CI = 0.06, 0.09) and SRMR = 0.06]. The reliability analysis results confirmed that the values of Cronbach\'s alpha coefficient for Skindex-16 were in the acceptable range (0.923).
Our evaluation of the Skindex-16 indicates that it is reliable and a valid instrument that can be used for measuring QoL for Iranian dermatologic patients.

BACKGROUND: Capability well-being captures well-being based on people\'s ability to do the things they value in life. So far, no capability well-being measures have been validated in dermatological patients.
OBJECTIVE: To validate the adult version of the ICEpop CAPability measure (ICECAP-A) in patients with dermatological conditions. We aimed to test floor and ceiling effects, structural, convergent and known-group validity, and measurement invariance.
METHODS: In 2020, an online, cross-sectional survey was carried out in Hungary. Respondents with self-reported physician-diagnosed dermatological conditions completed the ICECAP-A, Satisfaction with Life Scale (SWLS), WHO-5 Well-Being Index and two dermatology-specific measures, Dermatology Life Quality Index (DLQI) and Skindex-16.
RESULTS: 618 respondents (mean age 51 years) self-reported a physician-diagnosed dermatological condition, with warts, eczema, onychomycosis, acne and psoriasis being the most common. ICECAP-A performed well with no floor and mild ceiling effects. The violation of local independence assumption was found between the attributes of \'attachment\' and \'enjoyment\'. ICECAP-A index scores correlated strongly with SWLS and WHO-5 (rs = 0.597-0.644) and weakly with DLQI and Skindex-16 (rs = - 0.233 to - 0.292). ICECAP-A was able to distinguish between subsets of patients defined by education and income level, marital, employment and health status. Multigroup confirmatory factor analysis indicated measurement invariance across most of these subgroups.
CONCLUSIONS: This is the first study to validate a capability well-being measure in patients with dermatological conditions. The ICECAP-A was found to be a valid tool to assess capability well-being in dermatological patients. Future work is recommended to test measurement properties of ICECAP-A in chronic inflammatory skin conditions.

BACKGROUND: This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT).
METHODS: Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients\' quality of life (QoL) through Skindex-16 questionnaire.
RESULTS: Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018. Groups were well balanced for population characteristics. All BC patients underwent 3-Dimensional Conformal RT (3D-CRT) whereas HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT). At week 5 the proportion of BC patients who did not exhibit G2 ARD was higher in Xonrid® + SOC group (p = 0.091). In the same group the onset time of G2 ARD was significantly longer than in SOC-alone group (p < 0.0491). For HNC groups there was a similar trend, but it did not reach statistical significance. For both cancer sites, patients\' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
CONCLUSIONS: Despite the failure to achieve the primary endpoint, this study suggests that Xonrid® may represent a valid medical device in the prevention and treatment of ARD at least in BC patients, delaying time to develop skin toxicity and reducing the proportion of patients who experienced G2 ARD during RT treatment and 2 weeks later.
BACKGROUND: The study was approved by the Ethical Committee of Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT 52/14 - NCT02261181 ). Registered on ClinicalTrial.gov on 21st August 2017.

BACKGROUND: Facial blemishes resulting from skin disorders have a significant effect on the patient\'s self-esteem and impact quality of life (QOL).
OBJECTIVE: To assess the impact of a corrective cosmetic (CC) on QOL on top of skin quality parameters.
METHODS: An international observational study was conducted on subjects with visible facial flaws that would benefit from a corrective cosmetic. Investigators collected data regarding demographics, QOL using the Skindex-16 scale, skin dryness and tautness, subject and investigator satisfaction, cosmetic acceptability and tolerance at baseline and after 4 to 6 weeks of daily use.
RESULTS: A total of 1840 subjects participated; the mean age was 31.5±11.1 and 95% were women. Acne accounted for 48.9% of skin conditions, followed by melasma (16.7%) and rosacea (15.3%). Of the subjects 81.2% had at least 10% of the face affected and the condition was rated as disfiguring by 45.3% of the subjects; 45.0% and 44.4%, respectively, had neither taut nor dry skin at baseline. Baseline Skindex-16 scores for symptoms, emotions, functioning and overall were 1.4±1.3, 3.5±1.6, 2.4±1.8 and 2.4±1.3, respectively, on a scale from 0 to 6. Compliance was 96.0±10.6%. At the end of the study, Skindex-16 scores had significantly (p<0.0001) improved for all parameters, as did skin dryness and tautness. Subject and investigator satisfaction were high or very high; cosmetic acceptability was high or very high and local tolerance good or very good.
CONCLUSIONS: The tested corrective cosmetic significantly improved the QOL of subjects with significant facial flaws, skin tautness and dryness, and was well tolerated.

BACKGROUND: Atopic dermatitis (AD), a chronic, highly pruritic skin disorder, impairs quality of life (QoL). Janus kinase inhibitors suppress inflammatory and pruritus-associated cytokine signaling in AD.
OBJECTIVE: To report the effects of ruxolitinib (RUX) cream on itch and QoL in AD.
METHODS: A total of 307 adult patients with an Investigator\'s Global Assessment (score of 2 or 3) and 3% to 20% affected body surface area were randomly assigned for 8 weeks to receive double-blind treatment with RUX (1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily), vehicle twice daily, or triamcinolone cream (0.1% twice daily for 4 weeks then vehicle for 4 weeks). Itch was measured by using the numerical rating scale, and patient QoL was assessed with Skindex-16.
RESULTS: Improvements in itch numerical rating scale and Skindex-16 were observed with RUX cream. Overall, 42.5% of patients who applied 1.5% RUX twice daily experienced minimal clinically important difference in itch within 36 hours of treatment (vehicle, 13.6%; P < .01); near-maximal improvement was observed by week 4. Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P < .001). Significant improvements in Skindex-16 overall scores were noted at week 2.
CONCLUSIONS: Facial AD lesions were not treated.
CONCLUSIONS: RUX cream provides a clinically meaningful reduction in itch and QoL burden.

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