An explanatory sequential mixed-methods design to establish thresholds of within-individual meaningful change on a sleep disturbance numerical rating scale score in atopic dermatitis.

PURPOSE: Establishing a meaningful within-individual change (MWIC) threshold is a key aspect for interpreting scores used as endpoints for evaluating treatment benefit. A new patient-reported outcome (PRO), a sleep disturbance numerical rating scale (SD NRS), was developed in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This research aims to establish a MWIC threshold of the SD NRS score in the context of a drug development program. METHODS: An explanatory sequential mixed-methods design was used to address the research objective. This mixed-methods design used phase IIb data and a stand-alone qualitative study. Quantitative anchor-based and distribution-based approaches supported by qualitative-based approaches were conducted, and results were triangulated to determine preliminary MWIC thresholds of the SD NRS score. RESULTS: Triangulation of results from both quantitative and qualitative approaches suggested that a 2- to 6-point decrease in the SD NRS score change constitutes a preliminary range of MWIC threshold estimates. CONCLUSION: This research determined MWIC threshold estimates for the SD NRS score in both adolescents and adults with moderate-to-severe AD using an explanatory sequential mixed-methods design. This mixed-methods design provides interesting insights for establishing MWIC thresholds of a PRO score in the context of a drug development program.

Comorbidities, healthcare resource utilization & treatment pattern among patients with prurigo nodularis, compared to a benchmark in Germany: A real-world evidence claims data study.

BACKGROUND: Prurigo nodularis (PN) is a rare chronic inflammatory skin disease with a high disease burden, but data on clinical and economic burden are still scarce. OBJECTIVE: To describe the real-world epidemiologic, clinical and therapeutic characteristics and related economic burden of patients with PN compared to a benchmark population in Germany. METHODS: This retrospective study was based on an excerpt of German Statutory Health Insurance data of patients with an initial PN diagnosis between 2012 and 2016. PN cohort contained no record of PN in eight quarters before the index quarter and was followed up for eight quarters (unless deceased). Benchmark cohort without PN was calculated using direct standardization and 1:1 matching to PN cohort. RESULTS: Out of 4,536,002 insured patients, 2309 incident patients with PN were identified and matched to the benchmark cohort out of 3,018,382 patients without PN. Patients were mostly between 45 and 80 years when diagnosed with PN. Higher comorbidity rates were reported for PN than benchmark, with a rising disease burden at follow-up. Most patients with PN (91.3%) were diagnosed outpatient and had >50% more outpatient visits than the benchmark cohort. Hospitalization rates were higher in PN (53.9%) versus benchmark (35.1%), yielding twice longer mean hospital stays for PN (12 days) compared to benchmark (6 days) (p < 0.001). The most common initial therapy for patients with PN was topical corticosteroids (47.6%); ≥10% of patients were treated with antidepressants, antihistamines or systemic corticosteroids. Therapy rates were higher for PN compared to benchmark (p < 0.001). Mean initial costs were twofold higher in PN versus benchmark for outpatient, inpatient and drugs. During follow-up, an increase of >70% in mean PN costs compared to benchmark was identified for outpatient, inpatient and concomitant treatments (p < 0.001). CONCLUSION: This study highlights the significantly higher clinical and economic burden incurred by PN compared to benchmark patients in Germany, reflecting the unmet medical need for PN.

Tretinoin Review With Newer Formulations: Providing Effective and Tolerable Solutions in Clinical Practice.

Topical tretinoin has historically been limited by poor tolerability and molecular instability. Research advances have enhanced its efficacy and tolerability, along with reducing oxidation and photodegradation. By overcoming historical limitations, tretinoin use can be extended to patient populations and clinical situations previously not suitable. This review discusses historical limitations of tretinoin, methods employed to overcome those limitations, use within clinical practice, and new formulations of tretinoin for the treatment of acne. J Drugs Dermatol. 2023;22(1):35-40. doi:10.36849/JDD.7146.

Management of Acne Vulgaris With Trifarotene.

Topical retinoids have an essential role in treatment of acne. Trifarotene, a topical retinoid selective for retinoic acid receptor (RAR) γ, is the most recent retinoid approved for treatment of acne. RAR-γ is the most common isoform of RARs in skin, and the strong selectivity of trifarotene for RAR-γ translates to efficacy in low concentration. Trifarotene, like other topical retinoids, acts by increasing keratinocyte differentiation and decreasing proliferation, which reduces hyperkeratinization. Retinoids have also been shown to inhibit inflammatory pathways via effects on leukocyte migration, toll-like receptors, and Activator Protein (AP)-1. Large-scale randomized, controlled clinical trials have demonstrated trifarotene to be safe, well tolerated, and efficacious in reducing both comedones and papules/pustules of acne. However, unlike all other retinoids, trifarotene is the first topical retinoid with rigorous clinical data on safety and efficacy in truncal acne. Data supporting use of trifarotene to manage acne are reviewed in this publication.

Longitudinal course and predictors of depressive symptoms in atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is associated with eczematous lesions, pruritus, pain, and sleep disturbance, which may negatively impact mental health over time. OBJECTIVE: To determine the predictors and longitudinal course of depressive symptoms in adults with AD. METHODS: A prospective, dermatology practice-based study was performed (N = 695). AD signs, symptoms, and severity and patient health questionnaire-9 (PHQ-9) were assessed. RESULTS: At baseline, of the 695 participants, 454 (65.32%) had minimal, 139 (20.00%) had mild, 57 (8.20%) had moderate, 27 (3.88%) had moderately severe, and 8 (2.59%) had severe depression. Most had fluctuating levels of depressive symptoms. Feeling bad, thoughts of self-harm, difficulty concentrating, and slow movement were most persistent. Predictors of persistent depression included older age, non-White race, male sex, public or no insurance, more severe itch, skin pain, facial erythema, nipple eczema, sleep disturbance, and presence of pityriasis alba. LIMITATIONS: Single center study. CONCLUSION: Depressive symptoms are closely related to and fluctuate with AD severity over time. Improved control of AD signs and symptoms, particularly itch, may secondarily improve mental health.

Health-related quality of life and economic burden of prurigo nodularis.

BACKGROUND: Prurigo nodularis (PN) is an understudied, pruritic inflammatory skin disease. Little is known about the effect of PN on quality of life and its associated economic burden. OBJECTIVE: To quantify the impact of PN on quality of life and its economic implications. METHODS: A cohort study of PN patients (n = 36) was conducted using the Health Utilities Index Mark 3 questionnaire. Control data from US adults (n = 4187) were obtained from the 2002-2003 Joint Canada/United States Survey of Health. Quality-adjusted life year loss and economic costs were estimated by comparing the Health Utilities Index Mark 3 scores of the PN patients with those of the controls. RESULTS: The PN patients had lower overall health performance compared to the controls, (mean ± SE, 0.52 ± 0.06 vs 0.86 ± 0.003, respectively, P < .001). In multivariable regression, PN was found to be associated with worse health performance (coefficient -0.34, 95% CI [-0.46 to -0.23]), most prominent in the pain subdomain (coefficient -0.24, 95% CI [-0.35 to -0.13]). This correlated to an average of 6.5 lifetime quality-adjusted life years lost per patient, translating to an individual lifetime economic burden of $323,292 and a societal burden of $38.8 billion. CONCLUSION: These results demonstrate that PN is associated with significant quality-of-life impairment, similar to the level of other chronic systemic conditions. PN is also associated with a substantial individual economic burden, emphasizing the necessity of research on effective treatment options.

Clinical phenotyping of atopic dermatitis using combined itch and lesional severity: A prospective observational study.

BACKGROUND: Patients with atopic dermatitis (AD) have heterogeneous clinical phenotypes, including different combinations of itch and lesional severity. Little is known about the characteristics and course of these subtypes. OBJECTIVE: To determine the characteristics, associations, burden, and course of patients with AD using combined itch and lesional severity. METHODS: A prospective practice-based study was performed using questionnaires and physical examination (n=592). AD subsets were defined using verbal rating scale for average itch combined with either eczema area and severity index, objective-scoring atopic dermatitis (SCORAD), or validated investigator's global assessment as follows: mild-moderate itch and lesions (MI-ML), mild-moderate itch and severe lesions (MI-SL), severe itch and mild-moderate lesions (SI-ML), and severe itch and lesions (SI-SL). RESULTS: At baseline, there were only weak-moderate correlations of numerical rating scales for worst itch or average itch or SCORAD itch with eczema area and severity index, objective-SCORAD, body surface area, and validated investigator's global assessment (Spearman's rho = 0.32-0.62). Most patients had MI-ML (59.4%-62.3%), followed by SI-ML (21.3%-29.1%), SI-SL (6.0%-12.9%), and MI-SL (3.8%-6.4%). Patients with SI-SL, followed by SI-ML and MI-SL, described their AD as being more severe overall and had worse impairment in sleep, mental health, and quality of life. However, those with MI-SL or SI-SL were far more likely to be classified as severe by a physician (multivariable logistic and linear regression, P < .005 for all). Baseline MI-SL, SI-ML, and SI-SL were associated with similar longitudinal courses over time and more AD flares and itch triggers than MI-ML. CONCLUSION: Combined itch and lesional severity seem to describe unique AD phenotypes. Further studies are needed to confirm these findings and understand the optimal treatments for these groups.

Validity and reliability of Patient-Reported Outcomes Measurement Information System Global Health scale in adults with atopic dermatitis.

BACKGROUND: Patient-Reported Outcomes Measurement Information System Global Health (PGH) was validated to assess health-related quality of life in several diseases. Little is known about its measurement properties in adult atopic dermatitis. OBJECTIVE: Examine the measurement properties of PGH in adult atopic dermatitis. METHODS: A prospective dermatology practice-based study of 994 atopic dermatitis patients (18-97 years). RESULTS: PGH physical and mental health 4-item and abridged 2-item T scores, as well as mapped EuroQol-5D score, showed strong to very strong correlation with one another and moderate to strong Spearman correlations with Patient-Oriented Scoring Atopic Dermatitis, Patient-Health Questionnaire-9, Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment, Eczema Area and Severity Index, objective Scoring Atopic Dermatitis; and weak to moderate correlations with Patient Oriented Eczema Measure, numeric rating scale worst itch and average itch, and Scoring Atopic Dermatitis. The Dermatology Life Quality Index (DLQI) had stronger correlations with Patient Oriented Eczema Measure, Patient-Oriented Scoring Atopic Dermatitis, numeric rating scale worst itch and average itch, Eczema Area and Severity Index, and Scoring Atopic Dermatitis, but weaker correlations with Patient-Health Questionnaire-9 and Patient-Reported Outcomes Measurement Information System sleep disturbance and related impairment (convergent/divergent validity). PGH and DLQI scores had similarly poor ability to differentiate between levels of self-reported global atopic dermatitis severity (known-groups validity). No floor or ceiling effects were observed. No PGH or DLQI items had differential item functioning by demographics. PGH and DLQI scores showed fair to good responsiveness. Finally, PGH and DLQI showed similarly good test-retest reliability. LIMITATIONS: Single-center study. CONCLUSION: PGH scores had sufficient validity and reliability to assess health-related quality of life in atopic dermatitis.

A real-world study of the longitudinal course of adult atopic dermatitis severity in clinical practice.

BACKGROUND: Little is known about the longitudinal course of adult atopic dermatitis (AD) lesional severity and extent in clinical practice. OBJECTIVE: To determine the longitudinal course of AD in clinical practice. METHODS: A prospective, dermatology practice-based study was performed (n = 400). Patients were assessed at baseline and approximately 6, 12, 18, and 24 months by eczema area and severity index (EASI) and objective-scoring atopic dermatitis (objective-SCORAD). Multivariable repeated measures linear regression models were constructed to evaluate AD severity over time. RESULTS: Overall, 36.2% and 18.2% of patients had moderate (6.0-22.9) or severe (23.0-72.0) EASI scores at any visit, respectively. Similarly, 29.0% and 26.4% of patients had moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores at any visit, respectively. Among patients with baseline moderate (6.0-22.9) or severe (23.0-72.0) EASI scores, 25.0% and 18.6% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. Similarly, among patients with baseline moderate (24.0-37.9) or severe (38.0-83.0) objective-SCORAD scores, 22.6% and 24.5% continued to have moderate or severe scores at 1 or more follow-up visits, respectively. In longitudinal regression models, EASI was significantly associated with body surface area (adjusted ß [95% confidence interval]: 0.16 [0.09-0.23]) and edema/papulation (2.31 [0.19-4.43]). In addition, objective-SCORAD was significantly associated with body surface area (0.12 [0.04-0.21]), edema/papulation (4.69 [2.05-7.32]), and scratch (3.34 [0.45-6.24]) over time. CONCLUSION: AD lesional severity has a heterogeneous longitudinal course. Many patients had fluctuating lesional severity scores over time. A minority of patients had persistently moderate or severe lesions over time. Most patients with moderate-severe disease at baseline were unable to achieve persistent lesional clearance.

Comparison of Patient-Oriented Eczema Measure and Patient-Oriented Scoring Atopic Dermatitis vs Eczema Area and Severity Index and other measures of atopic dermatitis: A validation study.

BACKGROUND: Little is known about the measurement properties of Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) in adults with atopic dermatitis (AD). Even less is known about how PO-SCORAD performs compared with the Patient-Oriented Eczema Measure (POEM). OBJECTIVE: To examine the measurement properties of PO-SCORAD and compare them with those of POEM. METHODS: A prospective dermatology practice-based study of 291 patients with AD (age range, 18-72 years). RESULTS: PO-SCORAD and POEM were moderately correlated with each other (Spearman ρ = 0.56) and had weak-moderate correlations with the Numeric Rating Scale (NRS) worst itch and average itch, Dermatology Life Quality Index (DLQI), ItchyQOL, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI), Patient Health Questionnaire-9 (PHQ-9), and Eczema Area and Severity Index (EASI) (P < .001). POEM had significantly stronger correlations with DLQI, ItchyQOL, and EASI than did PO-SCORAD. PO-SCORAD and POEM had fair discriminant validity. Changes from baseline in PO-SCORAD and POEM were moderately correlated with each other; were weakly to strongly correlated with NRS worst itch and average itch, DLQI, ItchyQOL, PROMIS SD, PROMIS SRI, PHQ-9, and EASI; and had good test-retest reliability. There was no differential item functioning of items or floor or ceiling effects for PO-SCORAD or POEM. The thresholds for meaningful change for PO-SCORAD and POEM were -15.5 and -5.0, respectively. Median completion times for PO-SCORAD and POEM were 3 minutes and 1 minute, respectively. CONCLUSION: PO-SCORAD and POEM had good construct and cross-cultural validity, reliability, and responsiveness in adults with AD and were feasible for use in clinical trials and practice. However, POEM had better measurement properties than PO-SCORAD.

Association of itch triggers with atopic dermatitis severity and course in adults.

BACKGROUND: Atopic dermatitis (AD) is associated with heterogeneous triggers of itch, which may affect AD course and severity. OBJECTIVE: To characterize the triggers of itch in adult AD. METHODS: This was a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 587). Thirteen itch triggers were assessed using the patient-reported outcomes measurement information system Itch-Triggers. RESULTS: Overall, 381 (64.9%) patients reported greater than or equal to 1 itch trigger in the past week and 212 (36.1%) reported greater than or equal to 3 itch triggers. The most commonly reported triggers were stress (35.4%), sweat (30.5%), weather change (24.7%), dry air (24.4%), and heat (24.0%). In multivariable Poisson regression models, the number of itch triggers was associated with more severe patient-reported global AD severity, Numeric Rating Scale worst itch, Patient-Oriented Eczema Measure, Scoring Atopic Dermatitis sleep, Numeric Rating Scale skin pain, Eczema Area and Severity Index, and objective Scoring Atopic Dermatitis. The seasonality of AD was associated with distinct itch triggers. In multivariable logistic regression models, the number of itch triggers was associated with less than or equal to 3 months of AD remission during the year, greater than or equal to 2 AD flares, and AD being worse during some seasons. Four patterns of itch triggers were identified using latent class analysis, each associated with different clinical characteristics. CONCLUSION: Itch triggers are common and affect the course of AD. Itch triggers are an important end point to assess in patients with AD.

Validation of four single-item patient-reported assessments of sleep in adult atopic dermatitis patients.

BACKGROUND: The optimal approaches for monitoring sleep disturbances in adults with atopic dermatitis (AD) is not established. Multiple patient-reported outcome measures for AD and itch have sleep-related items. These items have not been validated previously. OBJECTIVE: Assess the measurement properties of sleep-related items from the Patient-Oriented Eczema Measure (POEM), SCORing AD (SCORAD), 5-dimensions of itch (5D), and ItchyQOL in adults with AD. METHODS: We performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 115). RESULTS: There was modest overlap and weak-moderate concordance of responses to the different assessments. Regarding concurrent validity, POEM-sleep, SCORAD-sleep, 5D-sleep, and ItchyQOL-sleep showed moderate correlations with each other. Regarding convergent validity, all items showed moderate correlation with total POEM, but weak correlations with Eczema Area and Severity Index (EASI), objective and total SCORAD, moderate to strong correlations with mean ItchyQOL and Dermatology Life Quality Index (DLQI), but poor or no significant correlation with Numeric Rating Scale (NRS) for worst or average itch. Regarding discriminant validity, all items showed significant and stepwise increases with increasing self-reported and physician-reported AD severity (Kruskal-Wallis, P < .01 for all). Floor effects were observed for POEM-sleep (n = 53, 46.1%), SCORAD-sleep (n = 28, 24.4%), 5D-sleep (n = 41, 35.7%), and ItchyQOL-sleep (n = 33, 28.7%); no ceiling effects were observed. Change in sleep-related item scores showed moderate strong correlations with change in POEM, 5Ditch, mean ItchyQOL, DLQI, objective and total SCORAD, and EASI, but inconsistent correlations with change of itch severity. CONCLUSION: Sleep-related items from POEM, SCORAD, 5D and ItchyQOL showed good validity and responsiveness to monitor sleep disturbances in adult AD patients.

Association of atopic dermatitis severity with cognitive function in adults.

BACKGROUND: Atopic dermatitis (AD) is associated with itch, pain, and sleep disturbance, all of which may contribute toward cognitive dysfunction. OBJECTIVE: To determine the relationship of AD severity and cognitive function in adults. METHODS: We performed a prospective dermatology practice-based study using questionnaires and evaluation by a dermatologist (n = 386). Cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function 8-item Short-Form. RESULTS: At baseline, 118 patients (58.1%) reported ≥1 symptoms of cognitive dysfunction in the past 4 weeks, with 29 (14.3%) having mild, 11 (5.4%) moderate, and 4 (2.0%) severe PROMIS Cognitive Function T-scores. In propensity score-weighted regression models, PROMIS Cognitive Function T-scores were inversely associated with patient-reported global AD severity, Patient Oriented Eczema Measure (POEM), Numeric Rating Scale worst itch and skin pain, SCORing Atopic Dermatitis (SCORAD)-sleep, POEM-sleep, Eczema Area and Severity Index, and SCORAD, with stepwise decreases of cognitive function with worsening AD severity. At all AD severity levels, cognitive dysfunction was associated with increased Dermatology Life Quality Index and ItchyQoL scores. Changes from baseline in PROMIS Cognitive Function T-scores were weakly to moderately inversely correlated with changes from baseline in multiple AD outcomes. LIMITATIONS: Single-center study without non-AD controls. CONCLUSION: Cognitive dysfunction is associated with AD severity. Cognitive function may be an important end point for monitoring treatment response in AD.

A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40-mg modified-release capsules, versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea.

BACKGROUND: Randomized controlled studies of combination therapies in rosacea are limited. OBJECTIVE: Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea. METHODS: This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy). RESULTS: A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated. LIMITATIONS: The duration of the study prevented evaluation of potential recurrences or further improvements. CONCLUSION: Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in cases of severe rosacea.

The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis.

BACKGROUND: An Investigator Global Assessment (IGA) is recommended by health agencies for drug registration in atopic dermatitis (AD). Current IGA scales lack standardization. OBJECTIVES: To develop an IGA scale, training module, and clinical certification examination for use in AD trials; establish content validity; and assess reliability. METHODS: Expert dermatologists participated in the development of the validated IGA for AD (vIGA-ADTM). Reliability (interrater and intrarater) was assessed by 2 web-based surveys. Clinical certification for investigators consisted of a training module and examination. RESULTS: Expert consensus was achieved around a 5-point IGA scale including morphologic descriptions, and content validity was established. Survey 1 showed strong interrater reliability (Kendall's coefficient of concordance W [Kendall's W], 0.809; intraclass correlation [ICC], 0.817) and excellent agreement (weighted kappa, 0.857). Survey 2, completed 5 months after training of dermatologists, showed improvements in scale reliability (Kendall's W, 0.819; ICC, 0.852; weighted kappa, 0.889). In this study, 627 investigators completed vIGA-AD training and certification. LIMITATIONS: Ratings were assessed on photographs. CONCLUSION: A validated IGA scale and training module were developed with the intent of harmonizing assessment of disease severity in AD trials. Strong reliability and excellent agreement between assessments were observed.

Early-stage Mycosis Fungoides: Epidemiology and Prognosis.

Most patients with mycosis fungoides are diagnosed with early-stage disease. However, prevalence of early-stage disease is unknown, and evidence of its burden is scarce. The aim of this study is to estimate the prevalence of early-stage mycosis fungoides, how long patients live with early-stage disease and to characterise these patients. Data were obtained from 4 key publications and from US cancer registries (Surveillance, Epidemiology and End Results Program; SEER). The derived incidence of early-stage mycosis fungoides was 0.26/100,000 (UK), 0.29/100,000 (US) and 0.38/100,000 (US-SEER) and the prevalence was 4.8/100,000 (UK), 5.2/100,000 (US) and 6.6/100,000 (US-SEER). Early-stage disease may last for 18 years. From SEER registries, 3,132 were diagnosed at early stage (mostly stage IA). Median age at diagnosis was 58 years. Compared with stage IA, the relative risk of death was 1.3 for stage IB and 3.5 for stage IIA. We confirm the rarity of early-stage mycosis fungoides, a differential prognosis and the potential for elevated burden of disease.

Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis.

Prurigo nodularis is an itchy skin disease with unknown epidemiology. This study aimed to describe the epidemiology of prurigo nodularis compared with that of psoriasis. The German sickness fund claims database, with 2,783,175 continuously insured patients, included 1,720 patients diagnosed with prurigo nodularis and 51,390 with psoriasis. Patients with prurigo nodularis were averagely 8 years older than psoriasis patients and more often were women (p < 0.001). Annual incidence was a constant 0.02% in prurigo nodularis, and decreased steadily from 0.53 to 0.42% in psoriasis; cumulative incidence was 0.1% for prurigo nodularis and 1.9% for psoriasis. Prevalence was 0.1% for prurigo nodularis and 4.7% for psoriasis, with a 1-year mortality of 5.4% for prurigo nodularis and 1.2% for psoriasis (p < 0.001). The most frequent pre-existing comorbidities in patients with prurigo nodularis were inflammatory dermatoses and depression. This epidemiological study found a low prevalence of prurigo nodularis, manifesting different demographics and comorbidities compared with psoriasis.

Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study

Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV­VI frequently develop acne. Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris. Methods: This was an open-label interventional study conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian, Latin-American, or black/African-American ethnicity, with an Investigator's Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and FST IV to VI. For 16 weeks, subjects applied 0.3% A/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Assessments included quality of life (QoL) and subject questionnaires, IGA, Investigator's Global Assessment of Improvement (GAI), postinflammatory hyperpigmentation (PIH; if present at baseline), and safety. Results: Fifty subjects were enrolled: 20 Asians, 17 black/African-Americans, and 13 Latin-Americans. Most had FST IV (74%) or V (22%), with moderate (70%; IGA 3) or severe (30%; IGA 4) acne. At week 16, 77% of subjects were satisfied or very satisfied with treatment, 56% of subjects had an IGA of 0 or 1 (clear/almost clear), and 87% had a good to excellent improvement in GAI. QoL improved throughout the study for all subjects; subject selection of "no effect at all" of acne on QoL increased from 16% of subjects at baseline to 55% at week 16. Of those with baseline PIH (60%), all were rated very mild to moderate. By week 16, the majority (75%) had no or very mild PIH, and the mean decrease in PIH was 27%. There were no adverse events leading to study discontinuation. Conclusion: Patients with SOC and moderate or severe facial acne reported high satisfaction with 0.3% A/BPO treatment and experienced good tolerability, improved QoL, treatment efficacy, and improvement in PIH. Clinicaltrials.gov number: NCT02932267 J Drugs Dermatol. 2019;18(6):514-520.