January 30, 2019

The rate of treatment success with tapinarof cream 1% applied twice daily was statistically significantly higher than the rate achieved with vehicle cream.

In adolescent and adult patients with atopic dermatitis (AD), treatment with tapinarof cream is both effective and well-tolerated, according to the results of a double-blind vehicle-controlled randomized phase 2 trial (ClinicalTrials.gov identifier: NCT02564055) conducted at 53 sites in the United States, Canada, and Japan between December 2015 and January 2017. Findings from the study were published in the Journal of the American Academy of Dermatology.

The investigators sought to evaluate the efficacy and safety of topical tapinarof cream (2 concentrations and 2 application frequencies) compared with vehicle in patients with AD. The participants were age 12 to 65, with AD body surface involvement of ≥5% to 35% and an Investigator’s Global Assessment score of ≥3 (ie, moderate or severe) at baseline.

The primary study end points included an Investigator’s Global Assessment score of clear or almost clear (ie, 0 or 1) and a minimum 2-grade improvement (ie, treatment success) at 12 weeks. Secondary end points included a ≥75% improvement in the Eczema Area and Severity Index score and a reduction in the numeric rating scale for itch from baseline.

At 12 weeks, rates of treatment success were 53% for a 1% concentration applied twice daily, 46% for a 1% concentration applied once daily, 37% for a 0.5% concentration applied twice daily, 34% for a 0.5% concentration applied once daily, 24% for twice-daily application of vehicle, and 28% for once-daily application of vehicle.

The rate of treatment success with tapinarof cream 1% applied twice daily was statistically significantly higher than the rate achieved with vehicle cream applied twice daily (53% vs 24%, respectively; 95% CI, 6.5%-48.1%). Treatment success was maintained for 4 weeks following the conclusion of tapinarof therapy.

The rate of treatment-emergent adverse events associated with the use of tapinarof cream was higher than that with vehicle cream (56% vs 41%, respectively), although all of the treatment-emergent adverse events reported were mild to moderate in intensity.

A major limitation of the study was the fact that the study population was relatively small, and thus larger confirmation trials are warranted.

The investigators concluded that tapinarof cream represents an important clinical advance in the development of topical medicine for the treatment of AD, with a unique mechanism of action that distinguishes this product from currently available topical therapies for AD.

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Reference

Peppers J, Paller AS, Maeda-Chubachi T, et al. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019;80(1):89-98.e3. doi:10.1016/j.jaad.2018.06.047

January 30, 2019

Fixed-combination HP/TAZ lotion to manage moderate to severe plaque psoriasis was effective and superior to individual active ingredients.

A fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion to treat moderate to severe psoriasis is more effective than its individual active ingredients and is associated with rapid and significant changes in disease severity, according to study results published in Journal of Drugs in Dermatology.

The investigators of this study sought to determine the effectiveness of a unique fixed-combination HP/TAZ lotion for treating moderate to severe plaque psoriasis using validated alternative tools for measuring improvement in psoriasis severity.

The study included 212 patients with moderate to severe plaque psoriasis in a post hoc analysis; participants were randomly assigned 2:2:2:1 to receive HP/TAZ lotion, individual active ingredients (HP or TAZ), or vehicle only. Participants applied treatment once daily for 8 weeks and were followed for 4 weeks post-treatment.

The investigators used a composite Investigator Global Assessment and Body Surface Area (IGAxBSA) tool to assess efficacy outcomes, specifically changes in erythema, plaque elevation, and scaling from baseline to week 12. The primary study end point was mean change in IGAxBSA composite scores; additional end points were the time required to achieve 25% and 50% reduction in mean baseline IGAxBSA composite scores and the proportion of patients achieving ≥75% reduction in mean baseline IGAxBSA composite scores.

The study results showed HP/TAZ lotion was significantly superior to HP, TAZ, and vehicle at week 12 for reducing psoriasis symptoms. By week 8, participants treated with HP/TAZ lotion achieved a greater reduction in mean IGAxBSA composite scores vs participants treated with HP (63.5% vs 49.2%; P =.056), TAZ (63.5% vs 15.2%; P <.001) or vehicle alone (63.5% vs 11.9%; P <.001); this was sustained throughout the 4-week post-treatment follow-up period vs TAZ and vehicle (P <.001) and vs HP (P =.003).

Using HP/TAZ lotion, a 25% improvement in mean IGAxBSA composite scores was achieved within 1.9 weeks, and a 50% improvement in scores was achieved within 4.6 weeks. Participants receiving other treatment achieved a 25% reduction in scores within 3 weeks, and did not achieve a 50% reduction in scores over the course of the study. Of the sample treated with HP/TAZ lotion, 47.5% achieved ≥75% reduction in mean baseline IGAxBSA composite scores by week 8, which was sustained for 4 weeks following the treatment period.

Limitations to the study included a small sample size that only included patients with moderate to severe psoriasis with a baseline IGA score of ≥3 and baseline BSA involvement of 3% to 12%.

Fixed-combination HP/TAZ lotion to manage moderate to severe plaque psoriasis was effective and superior to individual active ingredients; HP/TAZ lotion was associated with significant and rapid improvement of psoriasis indicated by a 63.5% reduction in mean baseline IGAxBSA composite scores. The investigators suggest that the addition of tazarotene to the fixed combination importantly helped sustain post-treatment benefit.

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Reference

Stein Gold L, Bagel J, Lebwohl MG, Lin T, Martin G, Pillai R. Halobetasol and tazarotene: further defining the role of a unique fixed combination topical lotion in moderate-to-severe plaque psoriasis. J Drugs Dermatol. 2018;17(12):1290-1296.

January 29, 2019

For facial assessments, the investigators found a significant improvement in GAIS scores across all time points from baseline to week 12.

According to study results published in the Journal of Drugs in Dermatology, Melaclear® serum used on the face with sun protection can improve skin quality, prevent photoaging, and help fight signs of facial aging.

The investigators of this single-center, observational, open-label study sought to assess the effectiveness and safety of a new generation non-tyrosinase topical agent  to brighten facial skin and improve skin quality, as well as reduce signs of facial aging.

The study sample included 10 healthy women, aged 30 to 70 years, from Barcelona, Spain with moderate photodamage (hyperpigmentation, sunspots) and signs of facial aging. Participants applied topical Melaclear serum twice daily — once in the morning and once in the evening — to the face and neck, along with sun protection, for 12 weeks.

Efficacy and tolerability outcomes were assessed at 4, 8, and 12 weeks using standardized photographs, expert investigator grading, and tolerability assessments. Visual examination of the face and neck assessed skin quality parameters, including radiance, smoothness, pigmentation, erythema, pore size, clarity, brightness, skin tone, luminosity, and complexion. Changes in wrinkle severity, photodamage, and hyperpigmentation, as well as Dermatologic Quality of Life, were further assessed.

The primary study end point was overall improvement in skin quality measured using the Global Aesthetic Improvement Scale (GAIS). Secondary end points evaluated a change in pigmentation via the modified Melasma Area and Severity Index (mMASI) and in Skin Quality Assessments. Treatment-related adverse events were reported throughout the study as safety outcomes, and tolerability was evaluated for the presence of stinging, burning, dryness, scaling, edema, and erythema.

For facial assessments, the investigators found a significant improvement in GAIS scores across all time points from baseline to week 12 (GAIS 1.3±0.6; P =.01), and a significant reduction in mMASI scores from week 8 onward. All investigator assessments of facial skin quality, photoaging, and hyperpigmentation showed significant improvement from baseline to week 12. Evaluated by the participants, GAIS scores and skin quality assessments improved from baseline to end of the study, and quality of life scores improved by 1.7 points; the average patient satisfaction rating for overall treatment efficacy was 2, or “satisfied.”

Investigator and participant assessments for the neck indicated mild improvement in skin quality but were not statistically significant at any time point. No adverse or unexpected events were reported over the course of study, and Melaclear serum was well tolerated.

Limitations to the study included a small sample size and short follow-up period. In addition, the mMASI test was not developed for the neck area and may not be optimal to measure changes in neck pigmentation.

After 3 months of treatment, Melaclear serum used twice daily with sun protection was well-tolerated and effective for improvement of facial skin quality and for the reduction of appearance of photodamage and hyperpigmentation in women with signs of facial aging. Future studies should compare Melaclear serum with traditional therapies in a larger sample of patients.

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Reference

Serra M, Krista B, Narda M, Granger C, Sadick N. Brightening and improvement of facial skin quality in healthy female subjects with moderate hyperpigmentation or dark spots and moderate facial aging. J Drugs Dermatol. 2018;17(12):1310-1315.

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January 29, 2019

Investigators obtained and evaluated digital dermoscopic images of 136 histopathologically confirmed cases of cutaneous smooth muscle neoplasms.

Dermoscopy may be helpful as an adjuvant diagnostic tool for piloleiomyiomas (PL), according to research published in the Journal of the European Academy of Dermatology and Venereology. Dermoscopic studies associated with angioleiomyomas (AL) and leiomyosarcomas (LS) were more variable and less reliable.

Investigators obtained and evaluated digital dermoscopic images of 136 histopathologically confirmed cases of cutaneous smooth muscle neoplasms (PL, n=114; AL, n=13; LS, n=9) from 10 hospitals in Spain, Austria, and Italy. Data included age and sex of patients, anatomical location of the lesions, the presence of pain, and the clinical diagnosis or differential diagnoses before excision.

Upon dermoscopy, the histologic pattern of a symmetric, total delicate pigment network with the variable presence of multiple hypopigmented areas in a painful lesion most commonly associated with PL was found in 69.3% of PL cases (79 out of 114 lesions) and not observed in any cases of AL and LS. PL was painful in 78.1% of the cases. Patients with PL presented with a delicate pigment network located on the whole lesion. Symmetric, pink-reddish tumors with vascular and white structures were observed in 46.2% of AL, as well as in 3.5% of PL and in 22.2% of LS. Asymmetric, multilobulated tumor with linear-irregular or polymorphic-atypical vessels and white structures were found most commonly in LS (44.4%) and were associated with malignant tumors such as melanoma.

Several limitations of this study exist. It was retrospective in nature, and the histopathologic diagnoses were unconfirmed by a second pathologist. Sensitivity and specificity of dermoscopic structure or pattern for the diagnosis of smooth muscle tumors were not analyzed.

The authors concluded that dermoscopy can help in diagnosing AL and LS, but because they can simulate more serious lesions, they should continue to be studied histopathologically.

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Reference

Zaballos P, del Pozo LJ, Argenziano G, et al. Dermoscopy of cutaneous smooth muscle neoplasms: a morphological study of 136 cases [published online December 6, 2018]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15392

January 29, 2019

Study investigators sought to determine if erythema assessment and percentage of ≥1-grade CEA improvement over time altered when assessment included a baseline facial photograph.

Introducing a baseline photograph to the critical evaluation of erythema reduction in clinical trials of oxymetazoline confirmed similar results, but led to significantly fewer participants achieving ≥1-grade Clinician Erythema Assessment (CEA) improvement, according to a study published in the British Journal of Dermatology.

Two phase 3 clinical trials of the once a day, topical cream oxymetazoline 1% showed that treatment significantly reduced facial erythema for patients with rosacea. These trials were identically designed and randomized and required live, static assessments of patients being treated once daily with oxymetazoline or vehicle. Study investigators sought to determine if erythema assessment and percentage of ≥1-grade CEA improvement over time altered when assessment included referring to a standardized, digital, baseline facial photograph.

Of the total 835 trial participants (oxymetazoline, n=415; vehicle, n=420), a significantly greater proportion of the oxymetazoline participants achieved ≥1-grade CEA improvement compared with vehicle (up to 85.3% vs 29.8%; P <.0001). When baseline photographs were used for reference during the evaluation of posttreatment photographs, oxymetazoline results were similar to phase 3 trial results, but with a significantly lower rate of ≥1-grade CEA improvement (up to 52.3% vs 29.7%; P <.001). At least a moderate improvement in erythema was achieved by up to 80.2% of oxymetazoline participants compared with up to 22.9% of vehicle participants, with a statistically significant association between participant satisfaction with facial redness and the percentage of erythema improvement (Spearman rank correlation, oxymetazoline, 0.1824; P <.0001; vehicle, 0.0623; P =.01).

Study investigators conclude, “In this study, a greater percentage of patients achieved improvement in persistent facial erythema of rosacea from baseline on the first day of application with oxymetazoline than with vehicle when investigators were allowed to reference the patient’s baseline photograph while evaluating posttreatment photographs to assess erythema severity over time.”

Disclosures: Study funding was provided by Allergan plc, Dublin, Ireland.

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Reference

Eichenfield LF, Del Rosso JQ, Tan JKL, et al. Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1.0% for persistent erythema of rosacea in a phase 4 study [published online November 30, 2018]. Br J Dermatol. doi: 10.1111/bjd.17462

January 28, 2019

Positive but weak associations were found between childhood atopic dermatitis and maternal history of depression, maternal alcohol abuse, and maternal illicit drug use.

Positive but weak associations were found between childhood atopic dermatitis (AD) and maternal depression, alcohol abuse, and illicit drug use, according to the results of a large, nationwide, case-control study conducted in Denmark and published in the Journal of the European Academy of Dermatology and Venereology.

The investigators sought to quantify the relationships between maternal and paternal psychiatric disease and the development of AD in children via use of nationwide health and social registries in Denmark. All Danish children who were born between January 1, 1996, and December 31, 2011, who developed AD prior to 5 years of age were identified and matched in a 1:10 ratio with control subjects from the general Danish population and with children receiving care in a similar ambulatory/hospital setting.

A total of 8602 pediatric patients with AD were matched with control subjects. Rates of parental psychiatric care were similar among those in the AD arm and those in the control arm. Compared with individuals in the general population, weak associations were reported among childhood AD and the following factors: (1) maternal history of depression or  depressive symptoms (odds ratio [OR] 1.18; 95% CI, 1.12-1.26; P <.0001); (2) maternal history of alcohol abuse (OR 1.37; 95% CI, 1.17-1.60; P <.0001); and (3) maternal history of illicit drug use (OR 1.34; 95% CI, 1.14-1.60; P =.0005). However, when the pediatric ambulatory/hospital group was used as the control arm, the associations were no longer significant: (1) OR 1.05; 95% CI, 0.99-1.13; (2) OR 1.14; 95% CI, 0.98-1.34; and (3) OR 1.03; 95% CI, 0.88-1.22, respectively.

Furthermore, no paternal psychiatric disease or prenatal maternal psychiatric disease was shown to be associated with the development of AD among the offspring evaluated.

The investigators concluded that the children of parents with substance abuse issues may be more inclined to receive a diagnosis of AD. A major strength of this study is that 2 separate control populations were used as comparators. A weakness of the current study is that it was limited to children who developed AD prior to 5 years of age, as well as to those who sought care at university- and hospital-based clinics. Moreover, based on the study design, causality cannot be determined.

Disclosure: Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.

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Reference

Hamann CR, Egeberg A, Silverberg JI, Gislason G, Skov L, Thyssen JP. Exploring the association between parental psychiatric disease and childhood atopic dermatitis: a matched case-control study [published online November 1, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15321

January 28, 2019

Investigators noted that itch-related improvements occurred before treatment efficacy was observed using modified PASI scores.

Topical calcipotriol/betamethasone dipropionate foam (Cal/BD foam) offers more effective and rapid itch relief in people with moderate to severe psoriasis compared with foam vehicle delivery of corticosteroids, according to study results published in the Journal of the European Academy of Dermatology and Venereology.

The investigators sought to examine the efficacy of topical fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam vs foam vehicle on symptoms of itch, itch-related sleep loss, and quality of life in patients with moderate to severe psoriasis.

The investigators pooled data from 3 Phase II/III trials comparing the effectiveness of Cal/BD foam vs foam vehicle in a cohort of 837 adults with mild to severe psoriasis over a 4-week treatment period. Participants demonstrated the presence of itch as a key symptom with a baseline itch visual analogue scale (VAS) score of >0 or >40.

Outcomes of interest were the absolute itch reduction of VAS >40 and achieving ≥70% improvement in itch relief and itch-related sleep loss. Other outcomes included improvement in modified Psoriasis Area Severity Score (PASI) ≥75% and achieving a Dermatology Life Quality Index (DLQI) score of 0/1, representing no or minimal impact of psoriasis on quality of life. Itch-related outcomes were assessed at baseline, day 3, and day 5 (phase III trial pool only), and weeks 1, 2, and 4 (extended pool).

In the overall cohort, 800 participants had baseline itch VAS >0 (Cal/BD foam, n=610; foam vehicle, n=190); of these 800 participants, 484 had severe baseline itch VAS >40. At baseline, the investigators did not identify any correlation between itch VAS score >0 and modified PASI (R²=0.021), and itch severity was comparable among Cal/BD foam and vehicle foam groups. At week 4, itch VAS scores were lower in the Cal/BD foam group vs foam vehicle group (mean VAS: 9.8±19.3 vs 30.3±28.4).

More participants with baseline itch VAS >40 achieved itch VAS reduction >40 using Cal/BD foam vs foam vehicle as early as day 5 (57.5% vs 40.2%; P <.05) and through week 4 (83% vs 45.8%; P <.001). Similarly, a greater proportion of Cal/BD foam users achieved a ≥70% improvement in itch at day 3 (32.2% vs 22.5%; P <.05) and continuing through week 4 (19.3% vs 38.1%; P <.001). Improvements in itch-related sleep loss were greater in patients with baseline itch VAS >40 and sleep loss >20 in the Cal/BD foam group vs the foam vehicle group; the differences in improvement measures between groups was significant at week 4.

Investigators noted that itch-related improvements occurred before treatment efficacy was observed using modified PASI scores. As for quality of life, significantly more Cal/BD foam users vs foam vehicle users with baseline DLQI scores >10 (Cal/BD, n=172; vehicle, n=50) achieved DLQI ≤1 (25% vs 4%; P =.001) or DLQI 0 (17.4% vs 2%; P =.006).

Limitations to the study included lack of validated tools to measure itch-related sleep-loss, lower participant numbers for early time points (days 3 and 5), and missing information comparing the efficacy of Cal/BD foam with its individual components.

Compared with foam vehicle delivery of corticosteroids, Cal/BD foam is more effective and rapid to relieve itch-related symptoms in patients with moderate-to-severe psoriasis. The reduction of itch from Cal/BD foam was further associated with improvements in sleep and quality of life. The investigators recommend the increased use of itch assessment tools for outcomes in future clinical studies.

Disclosure: This study was sponsored by LEO Pharma.

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Reference                    

Jalili A, Lebwohl M, Gold LS, et al. Itch relief in patients with psoriasis: Effectiveness of calcipotriol plus betamethasone dipropionate foam [published online December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15393

January 25, 2019

No significant differences in 2- or 5-year cumulative risk for keratinocyte carcinomas was reported among participants treated with 5-FU compared with those treated with imiquimod.

Although the use of 5-fluorouracil (5-FU) has been shown to reduce the overall risk for keratinocyte carcinoma (KC) compared with imiquimod therapy, in a real-life practice setting of patients with actinic keratosis (AK), no significant differences in the short- or long-term risk for site-specific KCs have been observed with 5-FU compared with imiquimod treatment.

A retrospective, longitudinal cohort study was conducted among all Kaiser Permanente Northern California health plan members aged 18 years or older who had been diagnosed with an AK in 2007 and had filled a prescription for 5-FU or imiquimod. Cohort members were followed for the development of any subsequent KC (ie, any KC, any basal cell carcinoma, or any squamous cell carcinoma). Results of the study were published in the Journal of the American Academy of Dermatology.

The investigators sought to compare the effectiveness of 5-FU vs imiquimod for the prevention of KCs. A total of 5700 patients participated in the study; 5062 of patients had filled a prescription for 5-FU and 638 had filled a prescription for imiquimod. They used an intention-to-treat analysis that controlled for potential confounding variables to calculate 2- and 5-year risk differences for the development of KCs overall and in field-treated areas.

The use of 5-FU was associated with a statistically significantly decreased risk for the development of any KC compared with the use of imiquimod (adjusted hazard ratio [aHR] 0.86; 95% CI, 0.76-0.97). In contrast, no significant differences in risk were reported according to tumor subtype: (1) squamous cell carcinoma: aHR 0.89; 95% CI, 0.74-1.07; (2) basal cell carcinoma: aHR 0.87; 95% CI, 0.74-1.03; or (3) site-specific KC: aHR 0.96; 95% CI, 0.81-1.14. Moreover, no significant differences in 2- or 5-year cumulative risk for KC was reported among participants treated with 5-FU compared with those treated with imiquimod.

A major limitation of the study is that generalizability of the findings to other practice settings may be limited. A major strength of the analysis is the use of Kaiser Permanente Northern California’s closed, prepaid, integrated healthcare system, which allowed for a real-world comparison of the efficacy of 5-FU and imiquimod within a well-characterized, stable population.

The investigators concluded that, in view of the burden that AKs pose to the healthcare system, including their high prevalence, significant cost, and potential for malignant progression, dermatologists should be aware of how available treatment options compare with respect to their effectiveness in the prevention of KCs.

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Reference

Neugebauer R, Su KA, Zhu Z, et al. Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: a cohort study [published online November 17, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.11.024

January 25, 2019

Dermatologists should consider the higher risk for complications among immunosuppressed patients undergoing MMS when counseling them and managing their care.

According to a study conducted at the Dermatologic and Mohs Surgery Center of the University of California, San Diego, ,immunosuppression — in particular immunosuppression after solid organ transplant and the use of immunosuppressive therapy — in patients undergoing Mohs micrographic surgery (MMS) is linked to a higher risk for postoperative complications, including surgical site infection and wound dehiscence. The results of a retrospective, cross-sectional chart review of patient characteristics, clinical characteristics, and complications in immunosuppressed patients undergoing MMS for basal cell carcinoma or squamous cell carcinoma during a 4-year period were published in the Journal of the American Academy of Dermatology.

The investigators sought to establish the incidence and nature of postsurgical complications among immunosuppressed patients undergoing MMS. All patients who underwent MMS between July 2011 and June 2015 were evaluated, with data obtained via review of electronic medical records. Complications were defined as an adverse event (AE) that occurred within 2 weeks after MMS that was directly related to the procedure and was evaluated by the medical staff at a follow-up visit. Possible AEs included a clinical diagnosis of wound bleeding, dehiscence, tissue necrosis, and surgical site infection (including a combination of purulence, erythema, tenderness, and/or warmth at the site of the lesion, with or without fever).

The overall rate of complications among all those who participated in the analysis was 5.0%. Complications were significantly more likely to occur in older than in younger patients (70.7 vs 67.8 years of age; P =.005). No significant differences according to gender were reported. Surgical site infection (2.5%) and wound dehiscence (0.51%) were more prevalent among those who were immunosuppressed, with an overall complication rate of 5.4% in this population.

Per univariable analysis, in a comparison of immunocompetent and immunosuppressed individuals, immunosuppression was associated with a 9.6-fold greater likelihood of the development of a postoperative complication (P =.003). Solid organ transplant was associated with an 8.824-fold greater likelihood of a postsurgical complication (P =.006), whereas immunosuppressive therapy was associated with a 5.775-fold greater likelihood of a postsurgical complication (P =.021).

The investigators concluded that dermatologists should consider the higher risk for complications among immunosuppressed patients undergoing MMS when counseling them and managing their care. Administering the lowest possible dose of immunosuppressive therapy to facilitate transplant tolerance yet not promote cutaneous surgical complications is a key clinical consideration that warrants additional study.

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Reference

Basu P, Goldenberg A, Cowan N, et al. A four-year retrospective assessment of post-operative complications in immunosuppressed patients following Mohs micrographic surgery [published online November 28, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.11.032