Researchers conducted a post hoc analysis of 2 identical multicenter, randomized, double-blind, vehicle-controlled phase 3 clinical studies in moderate to severe acne.

A novel tretinoin 0.05% lotion formulation is an effective, safe, and well-tolerated topical treatment for moderate to severe comedonal and inflammatory acne in a population of Hispanic patients, with no reports of the product causing or exacerbating postinflammatory hyperpigmentation. Results of the post hoc analysis were published in the Journal of Drugs in Dermatology.

The novel tretinoin formulation evaluated in this analysis was developed with the use of a novel polymerized emulsion technology to provide a treatment option for Hispanic patients with acne who may be sensitive to some of the skin irritation, dryness, and pigmentary changes associated with the use of other tretinoin products. A total of 766 Hispanic participants 11 to 50 years old were randomly assigned in a 1:1 ratio to receive tretinoin 0.05% lotion or vehicle, applied once daily for 12 weeks.

Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions, as well as treatment success, which was defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and “clear” or “almost clear.” Adverse events (AEs), safety, and cutaneous tolerability were all evaluated with the use of a 4-point scale (0=none and 3=severe).

At week 12, the mean percentage changes from baseline in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, with tretinoin 0.05% lotion compared with 51.1% (P =.001) and 38.7% (P <.001) with vehicle, respectively. These reductions demonstrated statistical significance. Treatment success was attained among 19.6% of participants by week 12 compared with 12.7% of vehicle-treated patients (P =.015).

The majority of AEs were mild and transient in nature. Overall, 4 serious AEs were reported (2 in each treatment group), but none of the AEs was  related to the treatment. Moreover, the incidence of treatment-related AEs was lower with tretinoin 0.05% lotion compared with that in the overall study population. The most commonly reported treatment-related AEs included application-site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability evaluations, which were mostly mild to moderate at baseline, improved at week 12. Slight transient increases in burning and scaling were observed over the first 4 weeks. The severity of hyperpigmentation was reduced progressively with treatment.

The investigators concluded that the novel tretinoin 0.05% lotion used in this study was effective, safe, and well tolerated by the participants. A longer-term study is warranted to provide additional insight into postinflammatory hyperpigmentation severity associated with this treatment in a Hispanic population.

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Reference

Cook-Bolden FE, Weinkle SH, Guenin E, Bhatt V. Novel tretinoin 0.05% lotion for once-daily treatment of moderate-to-severe acne vulgaris in a Hispanic population. J Drugs Dermatol. 2019;18(1):32-38.

Dermatologists have not traditionally played a systematic role in recommending and administering immunizations.

Widespread encouragement among dermatologists and other physicians to regularly recommend and/or offer the herpes zoster (HZ) vaccine to their patients is key to prevention of the disease.

Approved in 2017, the recombinant HZ vaccine (HZ/su) was designed to prevent HZ infection and associated sequelae with greater efficacy and safety than the zoster vaccine live (ZVL) precursor vaccine. A review and an update on the prevention of HZ infection, along with the current role played by dermatologists in fostering administration of the vaccine, was published in the Journal of Drugs in Dermatology.

Although dermatologists encounter patients with HZ infection regularly, recommendation of vaccination against the disease has been minimal over the past years, resulting in low rates of overall patient awareness and use of HZ vaccines. As the HZ/su vaccine has several improvements over the live vaccine, dermatologists nonetheless still encounter impediments to vaccine recommendation and administration, including concerns about efficacy, limited availability, and complex cost and reimbursement for vaccine administration. Moreover, dermatologists have not traditionally played a systematic role in recommending and administering immunizations.

The investigators conducted a review of the literature to study the current role played by dermatologists and other physicians in HZ prevention, the safety and efficacy of the HZ/su vaccine, potential barriers to its recommendation by dermatologists, and the practicality of administering HZ/su vaccines in dermatology offices. The primary search database used in the analysis was PubMed/Medline.

The HZ/su vaccine costs approximately $290 for 2 doses, which is more expensive than the ZVL vaccine which costs approximately $230. Although the vaccine is more expensive than the ZVL vaccine, because of the efficacy that has been demonstrated by the HZ/su vaccine in randomized controlled trials, the HZ/su vaccine has been deemed more cost-effective compared with the ZVL vaccine or nonimmunization according to the costs of HZ treatment and the management of possible sequelae.

The investigators concluded that dermatologists are in a prime position to make the HZ/su vaccine more available to their patients. If the HZ/su vaccine, or a means of receiving the vaccine, is offered regularly at dermatology appointments, not only will dermatologists become accustomed to recommending the vaccine, but patients will also be more likely to obtain the immunization at the time it is recommended. Additional options for increasing HZ vaccine use include educational training for healthcare providers, partnering with the manufacturers of the vaccine, partnering with pharmacies, and widespread patient education.

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Reference

Felix KA, Ediale CE, McMichael AJ. Update in herpes zoster prevention and the role of dermatologists. J Drugs Dermatol. 2019;18(1):18-22.

CeraVe products containing salicylic acid may significantly improve dry, flaky, or scaly skin conditions.

The daily use of a ceramide-containing cleanser and cream that also contains salicylic acid has been shown to improve skin conditions significantly in individuals with dry, flaking, and/or scaling skin. A cohort study of adults with mild to moderate dry skin conditions was conducted at 4 dermatology centers in Canada, with results published in the Journal of Drugs in Dermatology.

Between November 2017 and May 2018, a total of 35 adults (18 men, 17 women) with mild to moderate dry skin conditions were recruited to the multicenter cohort. Participants received treatment with CeraVe Hydrating Cleanser Bar (HCB) and CeraVe Renewing SA (CSA) cream. All participants were treated with the ceramide-containing cleanser and cream, which also contained salicylic acid. Ceramides are known to be key physiologic lipids required for construction and maintenance of the epidermal barrier of the skin.

The primary outcome of the study was the physician’s and participant’s evaluation of the participant’s skin condition by comparing baseline (day 0) with day 28±5 days using the Dry Skin Classification Scale and the Global Aesthetic Improvement Scale. Secondary study outcomes were participant satisfaction with use of the treatment regimen and product features using a 5-point Likert scale (1=strongly agree and 5=strongly disagree). Tolerability, safety, and quality-of-life aspects were also evaluated.

A total of 34 individuals completed the study, with 1 participant lost to follow-up. One body area (ie, torso, back or front, left or right arm, or left or right leg) could be chosen to be treated with the cleansing bar and CSA cream. The selection of body location was made by the participant in agreement with the physician who conducted the study. After cleansing using the bar, CSA cream was applied to the affected area twice-daily.

Daily use of the cleanser and CSA cream improved the skin condition significantly in participants with dry, flaking, and/or scaling skin when day 0 was compared with day 28. Per the ratings of both the physicians and the participants, significant improvements in skin condition were noted in the Dry Skin Classification Scale and the Global Aesthetic Improvement Scale (P <.05 for both). Moreover, participants indicated that the treatment improved their skin condition significantly by reducing the negative impact on their professional life, as well as on their self-image and social life (P <.05 for all). Use of the product proved to be safe, well tolerated, and comfortable.  

A major limitation of the current study that it presented a description of practice and did not include a comparator or control group. Thus, no cause and effect associations could be inferred. The investigators concluded that future studies are warranted to draw any conclusions about the evaluated products on possible underlying disease among the participants.

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Reference

Vender RB, Andriessen A, Barankin B, et al. Cohort using a ceramides containing cleanser and cream with salicylic acid for dry, flaking, and scaling skin conditions. J Drugs Dermatol. 2019;18(1):80-85.

Hyperhidrosis was more prevalent among both men and women who were obese compared with those of normal weight.

Obesity in adolescents is associated with an increased risk for hyperhidrosis, according to a study recently published in the Journal of the American Academy of Dermatology.

This cross-sectional study included 2,772,468 adolescent Israeli individuals, 59.6% of whom were male. These individuals had enrolled in compulsory military service between 1967 and 2016 and were given a medical examination at a mean age of 17.3 years old. Hyperhidrosis was diagnosed by a dermatologist, which was present among 1.5% of individuals (n=42,539; 68.9% men).

Hyperhidrosis was more prevalent among both men and women who were obese compared with those of normal weight (2.9% vs 1.5% and 1.6% vs 1.1%, respectively). The adjusted odds ratio (aOR) for overweight vs normal weight men was 1.3 (95% CI, 1.25-1.34), and the aOR for obese vs normal weight men 1.4 (95% CI, 1.34-1.46). For overweight and obese women vs normal weight women, the aORs were 1.1 (95% CI, 1.04-1.17) and 1.2 (95% CI, 1.07-1.27), respectively.

With each increasing body mass index unit, men experienced a 3.2% (95% CI, 1.029-1.035%) increase in risk for hyperhidrosis, and women experienced a 1.5% (95% CI, 1.010-1.019%) increase in risk. Among participants whose health was unimpaired, these results were accentuated. Among participants with obesity, those with class II obesity had higher odds ratios: 1.5 (95% CI, 1.3-1.6) for men and 1.4 (95% CI, 1.2-1.7) for women.

Limitations to this study included a lack of data on primary vs secondary hyperhidrosis, as well as a timespan of 5 decades over which hyperhidrosis criteria could have evolved.

The study researchers concluded that “obesity is associated with hyperhidrosis among adolescents. Future studies are required to further investigate this association and to determine whether weight reduction may have a therapeutic role in these patients.”

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Reference

Astman N, Friedberg I, Wikstrom J, et al. The association between obesity and hyperhidrosis: a nationwide, cross sectional study of 2.77 million Israeli adolescents [published online January 21, 2019]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.01.019

Nearly nearly 50% of patients with psoriasis are not appropriately screened or treated for depression,

Significantly increased risks for depression and suicidality have been found in patients with psoriasis, although nearly 50% of this population is not recognized or identified by dermatologists, according to a letter published in Journal of the American Academy of Dermatology.

In this cross-sectional, anonymous survey study, 74 dermatologists based in the United States completed surveys online or in-person at dermatologic meetings, which included the 2018 American Academy of Dermatology Annual Meeting, the New York University Advances in Dermatology Symposium, and the monthly meetings of Dermatologic Society of Greater New York.

More than half (57%) of participants agreed or strongly agreed that there is an unfulfilled need for patients with psoriasis to undergo frequent monitoring for depression and suicidal ideation and behavior, but only 27% include questions about mood in the majority of clinical encounters. Of this amount, only 7% use a depression screening tool for asking about mood (mean score, 7.8±2.5), discussing depression (mean score, 7.4±2.5), and referring to mental health services (mean score, 8.2±2.3). 

The mean score for asking about suicidal ideation and behavior  was only 6.3±2.8. There was significantly increased comfort among physicians when asking and talking about depression and suicidal ideation and behavior when using a screening tool. The frequency of screening was positively correlated with comfort asking and talking about depression and suicidal ideation and behavior. Finally, there was also a significant positive correlation between the number of systemic medications prescribed by providers and screening frequency.

This study was limited by a relatively small sample size and reliance on self-reported assessments. There is potential for selection and non-response bias due to the level of motivation of responders to participate.

Psoriasis has been independently associated with major depression in the literature; this underscores the importance of being able to identify depression and SIB among patients with psoriasis. The findings of this study highlight an important knowledge and practice gap. The authors suggest that “[f]urther medical education on the available depression screening tools, such as the [Patient Health Questionnaire-2] and how to implement them into practice may help improve care and more completely address the needs of psoriasis patients.”

Dr Ho declared affiliation with the pharmaceutical industry. Please refer to reference for a complete list of disclosures.

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Reference

Liang SE, Cohen JM, Ho RS. Screening for depression and suicidality in psoriasis patients: a survey of U.S. dermatologists [published online January 22, 2019]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2019.01.025

The main finding of this study was that the numbers of CD4+T, CD8+T, CD19+B, and CD56+NK cells were significantly reduced by treatment with FAEs.

Increased pharmacovigilance by additionally monitoring distinct T cell subset count in addition to absolute lymphocyte counts may provide more meaningful insights into the safety and efficacy of fumaric acid esters (FAEs) for the treatment of psoriasis, according to a study published in the Journal of the European Academy of Dermatology and Venereology.

This investigator-initiated subcohort study reviewed continuously recorded clinical and laboratory findings in patients with psoriasis (N=371) who were prescribed Fumaderm® between January 1996 and October 2012. Investigators quantitatively analyzed peripheral blood lymphocyte subsets data using flow cytometry before and during treatment with FAEs. All patients received monthly clinical assessments and quarterly complete blood count tests. The following antibodies were used: T lymphocytes (CD3+), helper T lymphocytes (CD3+CD4+), cytotoxic T lymphocytes (CD3+CD8+), B lymphocytes (CD19+), and natural killer (NK) cells (CD3-CD16+CD56+).

The main finding of this study was that the numbers of CD4+T, CD8+T, CD19+B, and CD56+NK cells were significantly reduced by treatment with FAEs. The mean lymphocyte count was significantly decreased by 23.9% within the first 3 months of treatment, and the counts continued to decrease over the course of treatment by approximately 40% of baseline values. The mean CD4+T cell and the mean CD8+T cell counts each declined significantly by 49.9% and 55.7%, respectively. The CD19+ B cell and CD56+ NK cell counts also decreased significantly by 27.7 % and 21.9 %, respectively, compared with mean baseline values.

This study was limited by its utilization of a retrospective data set. The data reported reflect the clinical experience of a single tertiary care center and may not be representative of the entire population of patients with psoriasis.

Based on their findings and long-term experience, the authors suggest that periodic monitoring of CD4+ and CD8+T cell counts in intervals of 4 months or fewer, in addition to monthly complete blood count and lymphocyte count, seems to be clinically relevant for making therapeutic decisions regarding continual and long-term use of FAEs.

Disclosures: This study was partly supported by Biogen GmbH, Ismaning, Germany. Please see the original reference for a complete list of authors’ disclosures.

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Reference

Dickel H, Bruckner T, Höxtermann S, Dickel B, Trinder E, Altmeyer P. Fumaric acid ester-induced T cell lymphopenia in the real-life treatment of psoriasis [published online January 24, 2019]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15448

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The investigators sought to compare the efficacy and safety of methotrexate to treat psoriasis in patients with and without psoriatic arthritis.

According to a study published in JAMA Dermatology, methotrexate is safe and effective as first-line treatment for patients with psoriasis. It is also more effective and better tolerated in patients without arthritis compared with patients with concomitant psoriatic arthritis.

The investigators of this prospective, single-center, observational study sought to compare the efficacy and safety of methotrexate to treat psoriasis in patients with and without psoriatic arthritis.

The study sample included 235 adults diagnosed with psoriasis recruited from a large university hospital in China: 128 participants with moderate-to-severe psoriatic arthritis and 107 without psoriatic arthritis. The participants all received a 12-week course of low-dose methotrexate therapy from April 2015 to December 2017. Severity and extent of psoriasis were assessed using the Psoriasis Area Severity Index and body surface area scores; blood cell counts, liver enzyme levels, and renal function were also measured at baseline and at weeks 4, 8, and 12. The primary outcomes of interest were changes in disease severity and adverse events.

Clinical and demographic differences between patient groups with and without psoriatic arthritis were not significant; however, the investigators noted that the psoriatic arthritis group had a higher rate of diabetes. The proportion of participants who achieved a 90% reduction in Psoriasis Area Severity Index scores from baseline to week 8 was significantly lower in patients with psoriatic arthritis vs patients without psoriatic arthritis (3.1% vs 11.2%; P =.02). This trend continued through week 12, with 14.8% of patients with psoriatic arthritis achieving a 90% reduction in scores vs 25.2% of patients without psoriatic arthritis (P =.049). At week 12, 41.4% of patients with psoriatic arthritis and 50.5% without (P =.19) achieved a 75% reduction in scores.

Most treatment-associated adverse events were reported as mild or moderate, and no participants dropped out due to severe adverse events. The incidence of adverse events was significantly higher in patients with psoriatic arthritis vs patients without psoriatic arthritis, including reports of dizziness (9.4% vs 0.4%; P =.007), gastrointestinal symptoms (25.0% vs 12.1%; P =.01), and hepatoxicity (26.6% vs 15.0%; P =.04). A methotrexate-induced elevation of liver enzyme alanine aminotransferase was more frequent in patients with arthritis and was associated with increased body mass index and smoking in both patient groups.

Limitations to the study included a short treatment course of 12 weeks and a single-center setting, limiting the generalizability of the findings. Folic acid supplementation was not prescribed with treatment, and therefore, gastrointestinal symptoms may have been overestimated.

Methotrexate to treat psoriasis was effective and well tolerated, however, it was less effective in patients with psoriatic arthritis. Additionally, more patients with arthritis reported adverse events, including dizziness and abnormal hepatic function. Risk factors of smoking and increased body mass index were associated with elevated alanine aminotransferase levels, which were significantly more frequent in patients with psoriatic arthritis. Therefore, methotrexate is recommended as first-line therapy for psoriasis patients without arthritis.

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Reference

Yan K, Zhang Y, Han L, et al. Safety and efficacy of methotrexate for Chinese adults with psoriasis with and without psoriatic arthritis [published online January 30, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.5194

Patients with psoriasis reported significantly higher values for parameters that address periodontal inflammation.

In patients with psoriasis, regular periodontal checkups are recommended and periodontal treatment should be initiated as soon as possible whenever required.

Recognizing that available data on the periodontal and dental status of patients with psoriasis are scant, study investigators conducted a prospective study in which individuals with psoriasis were compared with controls, and the results of their analysis were published in the Journal of Investigative Dermatology.

A total of 100 patients with plaque psoriasis (mean age, 47.4±14.7; range, 19 to 79) who presented at the outpatient service of a specialized psoriasis center, department of dermatology, University Medical Center Schleswig-Holstein, Campus Kiel in Germany and 101 controls without psoriasis (mean age, 46.9±16.8; range, 18 to 86) were enrolled in the study. Standardized measures were utilized to evaluate oral health, including Bleeding on Probing (BOP), Community Periodontal Index (CPI), and dental parameters based on the DMFT-index (cumulative index: total of teeth registered as decayed [“D”], missing [“M”], and filled [“F”]).

A Psoriasis Area and Severity Index (PASI) <10 was observed in 96% of patients with psoriasis, with 4% reporting a PASI >10. No treatment was administered in 9% of patients with psoriasis, whereas 25% were receiving topical therapy and 66% were receiving systemic therapy (50% on biologic agents, 21.2% on methotrexate, 21.2% on fumaric acid esters, 4.5% on systemic combination therapy, and 1% on other systemic treatments).

A post-matching strategy was applied for analysis, with 53 pairs of patients with psoriasis and controls without psoriasis in whom relevant factors with a possible impact on oral health status were taken into account. Results of the study demonstrated that the matched group of patients with psoriasis had significantly higher BOP values (P <.011) and CPI (P <.002) values compared with matched controls. Per logistic regression analyses, significant correlations were identified in the psoriasis group with high BOP and CPI values, but not with missing teeth. Moreover, patients with psoriasis reported significantly higher values for parameters that address periodontal inflammation.

The investigators concluded that based on the findings from this study, patients with psoriasis should undergo regular dental checkups on periodontal status and should receive any required treatment where necessary.

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Reference

Woeste S, Graetz C, Gerdes S, Mrowietz U. Oral health in patients with psoriasis – a prospective study [published online January 2, 2019]. J Invest Dermatol. doi:10.1016/j.jid.2018.12.014

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