Scholarly Activity

BACKGROUND: Ostomates suffer from multiple comorbidities and social stigma, which can be especially debilitating in young patients. TikTok has become a popular platform for this population to establish a community and gain resources. This study aims to characterize intestinal ostomy videos on TikTok.

METHODS: The top 50 videos for search terms "ileostomy," "colostomy," "ostomy," and "stoma" were queried on TikTok. Information was compiled regarding the videos' creators, content type, overall sentiment, and viewer engagement.

RESULTS: A total of 113 videos amongst 38 creators garnered 52,021,700 likes and 370,983 comments. Most videos focused on education (45.5%) and personal stories (22.7%). Creators were predominantly young females (82.0%), with minimal input from healthcare professionals (3% of videos). Sixty-nine (61%) of videos had responses with further questions.

CONCLUSIONS: Our study reveals a gap between interest and availability of professional educational material regarding intestinal ostomies. Addressing this deficiency may improve patient acceptance, bystander understanding, and its negative stigma.

Acne vulgaris affects nearly 50 million people in the USA, ranking as the eighth most prevalent disease globally. This chronic inflammatory skin condition often results in sequelae, including atrophic acne scars, acne-induced macular erythema and acne-induced hyperpigmentation, impacting patients' quality of life. This commentary article reviews the use of topical retinoids, with a particular emphasis on trifarotene cream 0.005%, for managing both acne and acne sequelae. Topical retinoids are considered central to improving treatment outcomes because of their established efficacy, safety and tolerability. Adapalene, tretinoin and tazarotene have demonstrated efficacy in reducing acne and acne sequelae in several studies. Trifarotene has been extensively studied in Phase 3 trials, demonstrating notable success in treating mild-to-moderate acne. Recently, two large-scale, randomized, blinded, Phase 4 clinical trials investigated trifarotene cream 0.005% in patients with atrophic acne scarring and acne-induced hyperpigmentation across all Fitzpatrick phototypes. The START study found that there was a greater reduction in total atrophic acne scar count in the trifarotene group compared with the vehicle group at Week 24 (55.2% vs 29.9%) with statistical significance established as early as Week 2 (P = 0.001). Based on this evidence, we recommend that topical retinoids should be introduced as first-line therapy for the treatment of acne and acne sequelae. Retinoids should be implemented into a treatment routine as early as possible, especially for patients with darker Fitzpatrick phototypes or patients at risk of atrophic acne scarring. Furthermore, retinoids should be incorporated within a comprehensive skincare regimen that includes adequate photoprotection when treating patients with darker Fitzpatrick phototypes. Finally, management of acne and acne sequelae should include maintenance therapy with topical retinoids. This article supports the American Academy of Dermatology's call for acne sequelae treatment guidance and emphasizes the need for continued research to optimize patient care.

INTRODUCTION: A systematic literature review and network meta-analysis (NMA) were conducted to compare the short-term efficacy of lebrikizumab to other biologic and Janus kinase (JAK) inhibitor monotherapies approved for moderate-to-severe atopic dermatitis in adults and adolescents.

METHODS: The NMA included randomized, double-blind, placebo-controlled monotherapy phase 2 and 3 trials of biologics (lebrikizumab 250 mg every 2 weeks [Q2W], dupilumab 300 mg Q2W, and tralokinumab 300 mg Q2W) and JAK inhibitors (abrocitinib 100/200 mg daily, baricitinib 2/4 mg daily, and upadacitinib 15/30 mg daily) at approved doses. Efficacy outcomes included the proportions of patients achieving Eczema Area and Severity Index (EASI) improvement, an Investigator Global Assessment of 0 or 1 (IGA 0/1), and a ≥ 4-point improvement in pruritus/itch numeric rating scale score at 12 weeks (abrocitinib) or 16 weeks (other treatments). Itch was also assessed at week 4. A Bayesian NMA employing baseline risk-adjusted random effects models was used to estimate treatment differences.

RESULTS: Twenty-two monotherapy studies involving 8531 patients were included in the NMA. By week 12/16, lebrikizumab had superior odds of achieving IGA 0/1 and itch improvement compared to baricitinib and tralokinumab; similar odds to dupilumab, abrocitinib, and upadacitinib 15 mg; and inferior odds to upadacitinib 30 mg. Additionally, lebrikizumab had a higher probability of improving EASI than baricitinib 2 mg; similar probability to baricitinib 4 mg, tralokinumab, dupilumab, abrocitinib, and upadacitinib 15 mg; and lower probability than upadacitinib 30 mg daily. At week 4, lebrikizumab had superior odds of improving itch compared to tralokinumab; similar odds to baricitinib, dupilumab, and abrocitinib 100 mg; and inferior odds to abrocitinib 200 mg and upadacitinib.

CONCLUSION: Among biologics, lebrikizumab was comparable to dupilumab and superior to tralokinumab in improving response rates at week 16. Upadacitinib 30 mg was the only JAK inhibitor with superior response rates compared to lebrikizumab.

Photodynamic therapy (PDT) is a versatile treatment with diverse applications in dermatology. PDT combines photosensitizers, most commonly 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), and a light source, such as light-emitting diodes (LEDs), fluorescent bulbs, lasers, flash lamps, or sunlight, in the presence of molecular oxygen to induce therapeutic effects primarily through singlet oxygen and reactive oxygen species generation. Downstream cellular and physiological effects include apoptosis, necrosis, and immune modulation. PDT efficacy depends on photosensitizer parameters, including photosensitizer type, concentration, dosing, temperature, and incubation time, and light source parameters such as light source, power density, wavelength, and fluence. PDT is generally safe and well tolerated; potential adverse effects such as pain and erythema are typically mild and self-limiting. Part I of this Continuing Medical Education (CME) provides a foundational overview of PDT principles, including mechanisms of action, photosensitizers, and light sources.

Photodynamic therapy (PDT) is a non-invasive treatment modality that uses photosensitizers in conjunction with a light source to induce therapeutic effects mediated in part through reactive oxygen species. PDT can be used as monotherapy or in combination with other treatments. In the United States, PDT is approved by the Food and Drug Administration for the treatment of actinic keratoses and is utilized off-label for other dermatologic conditions. Studies show that PDT has a favorable safety profile and, in order of level of evidence, has been used to treat actinic keratoses, basal cell carcinoma, cutaneous squamous cell carcinoma in situ, acne, port wine stains, cutaneous infections, photoaging, actinic cheilitis, mycosis fungoides, rosacea, alopecia areata, and Extramammary Paget disease. Part II of this CME provides a comprehensive overview of dermatologic clinical applications of PDT. Understanding the expanding evidence-based applications of PDT is crucial for dermatologists to ensure patient safety and optimize patient outcomes through tailored treatment protocols. Herein, we provide clinical descriptions of how to treat various dermatologic diseases using PDT so that clinicians may incorporate PDT into their practice.

BACKGROUND: So far, the evidence on the use of ultrasound (US) in hidradenitis suppurativa (HS) demonstrates the utility of US in the diagnosis, scoring and assessment of HS; however, to date, there is no international consensus statement on the use of US in HS, and several published guidelines do not include this topic.

OBJECTIVES: To create an international consensus statement on using US in HS that can cover and validate relevant aspects.

METHODS: A three-round Delphi study with a panel of international experts representing four continents and working with US in HS in their daily practice. The inclusion criteria of the experts and the set of questions in the survey were defined by a steering committee. A consensus of recommendation was defined when the percentage of agreement (sum of strongly agree and agree) was ε 70%. In between 50% and 69% of agreement, a suggestion was considered. Lower than 50% meant no consensus.

RESULTS: Twenty-four international experts from 14 countries participated in the study. A high percentage of consensus (96.4%) was achieved for important aspects of the use of US in HS, including the ultrasonographic indications, technical considerations, training, diagnostic criteria, staging systems, monitoring, support of US-guided procedures and planning of surgery, and the need for US in research and clinical trials.

CONCLUSIONS: An international group of experts created a consensus statement with validated recommendations on the use of US in HS. Despite the challenges of the implementation of ultrasound in HS, this task force highly recommends the use of US in HS.

Objectives: To quantify treatment priorities and unmet need among adults and adolescents with vitiligo in the United States (US). Methods: An adaptive self-explicated preference-elicitation survey was administered to adults (age ≥18 years) and adolescents (age 12-17 years) with non-segmental vitiligo. The preference-elicitation included 26 attributes related to treatment efficacy, safety, and mode of administration. Relative importance (RI) of each attribute was estimated using latent class analysis (LCA). Satisfaction with the 10 most important attributes for each patient was elicited using rating scales. RI and satisfaction were combined to estimate unmet need using a modified outcome-driven innovation approach which defines unmet need as high RI combined with low satisfaction. Results: The sample comprised adults (N=321) and adolescents (N-201) who received vitiligo care from 83 sites across the US. They had a mean (SD) age of 26 (9.1) and 14 (1.6) years, respectively. More than 50% of participants self-identified as non-White; 50% were female. Fitzpatrick skin types were 23.9% Type I-II (pale white, fair), 43.6% III-IV (darker white, light brown), and 32.4% V-VI (brown, black). LCA identified three preference segments: Efficacy (N=182,34.9%), most important attributes were amount of repigmentation on the entire body (RI=5.16) and reducing the emotional burden of vitiligo (RI=5.00); Mode of Administration (MOA) (N=159,30.5%), most important attributes were having an oral (RI=4.80), systemic (RI=5.03) treatment; Safety (N=181,34.7%), most important attributes were avoiding cardiovascular events (RI=4.53), cancer (RI=4.38), or shingles (RI=4.42). Among the full sample, the greatest areas of unmet need were reducing the emotional burden of vitiligo and having access to an oral systemic (rather than topical) treatment. Conclusions: Treatment preferences among people with vitiligo are heterogeneous. In addition to repigmentation, reducing the emotional burden of vitiligo is a key treatment goal for patients. An effective oral systemic treatment could help address unmet need in this patient population.

Background: Acne-induced post-inflammatory hyperpigmentation (PIH) is a common, long-lasting sequela of acne with a significant psychosocial impact. To assess its impact on sufferers, interviews were conducted in a phase IV study of trifarotene treatment of acne and PIH. Methods: Cross-sectional blinded qualitative interviews as a sub-study of a 6-month phase IV randomized controlled study of patients (n=123) with acne and moderate-to-marked PIH treated with trifarotene or vehicle. Semi-structured interviews conducted by trained interviewers with patients (n=30, 18-34 y). Results: Patients had a mean age of 24.8 years, 73.3% had Fitzpatrick skin types IV-VI, and 40% (12/30) were treated with trifarotene. More than half (60%) rated their PIH severity at ≥7 at study entry, and 57% said PIH disturbed their daily life at a level of 7 (0=no disturbance to 10=worst disturbance). Improvement in PIH was reported by 100% of the trifarotene group vs 83% in the vehicle group and those in the trifarotene group had a greater reduction in self-reported PIH severity (-5.5 vs -3.5 vehicle). Patients reported lack of treatment success with prior treatments but noticeable improvements in uniformity of skin color during this study: “my skin got brighter, lighter, the dark spots have faded,” and “at first it was very, very noticeable … it just faded.” Other patients reported increased self-confidence and reduced reliance on makeup and lengthy cover-up daily routines. AEs were more common with vehicle vs trifarotene (30.2% vs 16.7%). Conclusions: Patients described noticeable and meaningful changes in the appearance of PIH and daily life impacts.

Background: Trifarotene belongs to a new generation of topical retinoids for acne. Data indicate multiple mechanisms through which trifarotene may interrupt acne pathogenesis and improve acne-related scarring and pigmentation. Acne sequelae impact patients’ lives and frequently outlast the causative acne lesion. Thus, treatment addressing both acne lesions and sequelae is likely to improve long-term outcomes. Methods: Two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment (with appropriate skin care regimen) and 1) atrophic acne scarring and 2) acne-related hyperpigmentation. The scarring study (Study 1) utilized a split-face design (N = 121) while the pigmentation study (Study 2) randomized patients 1:1 to active or vehicle arms (N = 123). Results: In study 1, trifarotene treatment resulted in significant improvement in scar counts, with differences from vehicle apparent as early as week 2 (W2) and progressively improving through W24. There was also a significant difference between trifarotene and vehicle in scar global assessment (SGA) success from W12 through W24. Study 2 enrolled a diverse population of patients with a range of skin tones. In study 2, trifarotene treatment accelerated pigment reduction at week 12 vs vehicle. Active and vehicle were similar at week 24. Although not a defined study endpoint, reduction in macular erythema was also observed. Trifarotene was well tolerated in both studies, with tolerability scores higher than vehicle but mild in severity. Conclusions: Management of atrophic acne scarring and hyperpigmentation is an important consideration in acne therapy. Trifarotene achieved rapid improvements in these acne sequelae along with efficacious acne control.

Background: Acne is highly visible andone of the most common skin diseases. Healthcare professionals should have a reliable first-line approach that is efficacious and suited for a broad range of patient skin types, ages, and demographics. Methods: Including the Phase 3 program, trifarotene has been studied in thousands of acne subjects in clinical trials. Most recently two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment of acne and 1) atrophic acne scarring (4-1) and 2) acne-related hyperpigmentation (4-2). The scarring study 4-1) utilized a split-face design (N = 121) while the pigmentation study (Phase4-2) randomized subjects 1:1 to active or vehicle arms (N = 123). Results: The studies were international, with men and women in the studies ranging from 9 to 58 years of age. The phase 3 studies were majority White, but included substantial diversity, including 74 Black/African-American and 195 Latino subjects treated with trifarotene. In 4-2 <50% of subjects were White. Additionally, 30.6% of subjects in 4-1 and 61.7% of subjects in 4-2 had type IV-VI skin. Approximately 35% of subjects in 4-1 and 2 identified as Hispanic/Latino. In Study 2, 18.2% of subjects in the trifarotene group were Asian. In all studies, trifarotene was significantly superior to vehicle in improving acne. In 4-1, trifarotene rapidly improved atrophic acne scars and in 4-2 trifarotene reduced hyperpigmentation. In all studies, trifarotene had a positive risk/benefit ratio. Conclusions: Across a broad range of subject types, trifarotene had good efficacy for improving acne, atrophic scars, and hyperpigmentation, and safety.

Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically begins in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]) and children 2–<12 years old (y/o; TRuE-AD3 [NCT04921969]). Here, efficacy by baseline clinical characteristics in children 2–<12 y/o enrolled in TRuE-AD3 is reported. Methods: Patients 2–<12 y/o with AD for ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Results: Patients 2–<12 y/o (N=330) had a median (range) age of 6 (2–11) years; AD duration, 4.8 (0.3–11.3) years; mean (SD) affected BSA was 10.5% (5.40%). At Week 8, 49/134 (36.6%) children applying 0.75% ruxolitinib cream and 74/131 (56.5%) applying 1.5% ruxolitinib cream vs 7/65 (10.8%) applying vehicle achieved IGA treatment success (IGA-TS; score 0/1 with ≥2-grade improvement from baseline); 69/134 (51.5%) and 88/131 (67.2%) vs 10/65 (15.4%) achieved ≥75% improvement in Eczema Area and Severity Index (EASI75), respectively. IGA-TS was observed regardless of baseline AD severity measure. For IGA-TS: IGA score of 2 and 3, 32.3%/48.4% vs 0% and 37.9%/59.0% vs 14.3%, respectively; EASI score ≤7 and >7, 41.7%/58.8% vs 17.2% and 30.6%/55.0% vs 5.6%. Ruxolitinib cream was well tolerated; no serious treatment-emergent adverse events were reported. Conclusions: Ruxolitinib cream is a well-tolerated and effective treatment for AD in children 2–<12 y/o, independent of baseline clinical characteristics.

Introduction: High frequency ultrasound (HFU) has been shown to be useful for Hidradenitis Suppurativa (HS) evaluation along with physical examination.1 Sonographic features of HS include dermal thickening, widening of hair follicles, anechoic or hypoechoic fluid deposits and fistulous tracts.2,3 Pre-surgical margin mapping with HFU, prior to CO2 laser surgery – an effective treatment for HS, may reduce recurrence rates; however, there is little existing literature on margin mapping methodology.4 Methods: This work describes methodology for HFU margin mapping of HS lesions prior to CO2 laser surgery. Results: Unlike traditional US imaging, skin imaging requires utilization of transducers with high frequency (15 MHz and above). A 1-2 mm gel bed is required for better visualization of changes in superficial features.5 For margin mapping, dermal thickening was found to be the most relevant HFU feature of HS. Skin marker was used to mark the border at the transition point between normal and thickened dermis every 1-2 cm around the HS lesion to demarcate the area of excision. Isolated lesions within 2-3 cm on the surrounding skin were evaluated for the presence of any sinus tracts connecting them to the main lesion as that would impact the area to be excised. Conclusion: Change in dermal thickening was the most pertinent HFU feature of HS when performing preoperative margin mapping. Future studies are needed to evaluate if preoperative margin mapping of HS lesions with HFU correlates with lower recurrence rates.

Introduction: Hidradenitis suppurativa (HS), a chronic, systemic inflammatory skin disease characterized by deep, painful, and difficult-to-treat lesions, often requires rescue interventions alongside conventional treatment.[1] Here, we investigate the impact of bimekizumab (BKZ), a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F and IL-17A, on the need for concomitant rescue interventions in patients with moderate to severe HS. Methods: We report pooled, post hoc analysis from the initial treatment period (Weeks 0–16) of the BE HEARD I&II trials.[2,3] Adult patients with moderate to severe HS were randomized to BKZ (320mg every 2 weeks [Q2W] or Q4W) or placebo (PBO). The incidence of concomitant rescue interventions for HS, including medical (antibiotics, analgesics) and procedural (incision/drainage, intralesional triamcinolone injection), and time to first procedural intervention, are reported. Results: Overall, 1,014 patients were randomized to BKZ (n=868) or PBO (n=146) across BE HEARD I&II. In BKZ-treated and PBO-treated patients, 4.1% (n=36) and 8.9% (n=13) received ≥1 rescue analgesic; 4.0% (n=35) and 5.5% (n=8), received ≥1 rescue systemic antibiotic. Incidence of ≥1 incision/drainage intervention was 2.1% (n=18) in BKZ-treated and 3.4% (n=5) in PBO-treated patients; 1.6% BKZ-treated (n=14) and 3.4% PBO-treated (n=5) received ≥1 intralesional triamcinolone injection. Time to first procedural intervention was 65.3±36.2 (mean days±standard deviation) in BKZ-treated and 30.4±17.0 in PBO-treated patients. Conclusions: Over 16 weeks, the incidence of concomitant interventions for HS was low in BKZ-treated patients; low levels of rescue analgesic use in BKZ-treated patients may indicate reduced pain burden. Time to first procedure was numerically longer for BKZ- versus PBO-treated patients.

Roflumilast is a nonsteroidal, highly potent phosphodiesterase 4 inhibitor developed as once-daily cream and foam formulations being studied in patients for long-term treatment of atopic dermatitis and seborrheic dermatitis (SD). Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Efficacy and safety of once-daily roflumilast foam 0.3% in patients ≥9 years old with at least moderate SD from this phase 3 randomized controlled trial (NCT04973228) were reported previously. Roflumilast foam 0.3% (n=304) demonstrated statistically significant improvements in efficacy compared with vehicle (n=153) with low rates of adverse events, which were similar between treatment groups. Here we report the patient-reported outcomes: Worst Itch Numeric Rating Scale (WI-NRS), Scalpdex, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI), and local tolerability. Among patients with baseline WI-NRS score ≥2, more roflumilast-treated than vehicle-treated achieved WI-NRS score 0/1 at Week 8 (70.7% vs. 52.9%; P=0.0085), with improvements in itch compared to vehicle as early as 48 hours after first treatment (mean percent change from baseline [CfB]: -27.87% vs. -13.11%; nominal P=0.0024). Roflumilast-treated patients reported greater improvements in least squares (LS) mean CfB DLQI score (-3.8 vs. -2.7; nominal P<0.001), while those with scalp involvement, had greater improvements in LS mean CfB Scalpdex score (-23.21 vs. -15.42; nominal P<0.001) at Week 8. Local tolerability and safety were favorable. Treatment with once-daily roflumilast foam 0.3% reduced pruritus and improved quality of life with favorable tolerability. Sponsored by Arcutis Biotherapeutics, Inc.

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle and was well-tolerated in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in two pivotal phase 3 trials (ADORING 1 and 2). Here, we present baseline characteristics and outcomes from the prespecified interim analysis of ADORING 3, the long-term extension trial assessing safety and efficacy of up to 48-weeks’ open-label tapinarof. 728 patients enrolled in ADORING 3, representing a large, diverse AD population comprising a high proportion (91%) of eligible patients from the pivotal ADORING trials, 28 patients from a 4-week maximal usage pharmacokinetic trial, and an additional 76 tapinarof-naive patients aged 2-17 years with various disease severities (mild; or moderate or worse with body surface area [BSA] ≥40%), who were ineligible for preceding trials. The majority of patients in ADORING 3 were pediatric; 26.6% were aged 2-6 years; 27.1% 7-11 years; 29.3% 12-17 years; and 17.0% were adults. Overall, 46.6% were male, 52.6% White, 11.1% Asian, 30.1% Black/African American, and 4.4% other race categories. Patients with AD present different phenotypes and treatment responses. A high proportion of primarily pediatric patients elected to rollover from previous trials, and the diverse population enrolled in ADORING 3 is representative across the broad spectrum of disease severity, BSA affected (up to 95%), and demographics. No new safety signals were reported with long-term treatment in this interim analysis. The full analysis in 2024 will report further safety and efficacy data with tapinarof cream 1% QD.

Introduction: New topical treatments were recently FDA approved for patients with plaque psoriasis. This study was designed to assess the effect of education on knowledge, competence, and confidence regarding new topical psoriasis treatments. Methods: Dermatologists (n= 76) participated in an online CME activity that featured video with synchronized slides. A repeated-pair design with pre/post-assessment including 3 multiple choice questions that assessed knowledge or competence and one confidence assessment question assess effectiveness, with each participant serving as his/her own control. A McNemar’s test was conducted to assess question level statistical significance (P <.05). The activity launched 3/10/23 and data were collected approximately 60 days post-launch. Data are presented as %improved (%pre/%post) correct responses. Results are presented by learning theme. New Topical Psoriasis Treatments: • 11% improved (58%/54%; P = NS) change in knowledge regarding calcipotriene/ betamethasone data • 34% increase in confidence in identifying patients who would benefit from new topical psoriasis treatments Psoriasis in Sensitive Areas: • 18% (49%/63%) increase in knowledge about the suitability of roflumilast in difficult to treat areas Psoriasis in Patients with Skin of Color: • 18% improved (53%/67%) competence in counseling patients with diverse skin tones on pigmentary changes associated with healing psoriasis. Discussion: Online CME resulted in improved knowledge, competence, and confidence among dermatologists regarding new topical psoriasis treatments. Baseline and post-education results suggest that there are remaining gaps regarding new topical treatments, managing psoriasis in difficult areas, and in treating psoriasis in patients with diverse skin tones.