Scholarly Activity

BACKGROUND: Patients treated with a 1726-nm laser showed significant improvement in moderate-to-severe acne for ≥ 6 months in a prospective study.

OBJECTIVE: One-year follow-up data are presented.

METHODS: In this prospective institutional review board-approved study, patients underwent 3 treatments with a 1726-nm laser, 2-5 weeks apart. Inflammatory lesion counts and Investigator's Global Assessment scores were assessed at baseline, 3 months, and 1 year after treatment. Adverse events, treatment satisfaction, and self-confidence were assessed.

RESULTS: Of 104 patients with Fitzpatrick skin types II-VI and moderate-to-severe acne, 89 and 71 patients, respectively, attended 12- and 52-week visits. At 12 weeks, 79.8% demonstrated ≥ 50% improvement in inflammatory lesion counts, which increased to 91.5% at 52 weeks. The proportion of patients with clear or almost clear Investigator's Global Assessment scores increased from 36.0% at 3 months to 66.2% at 52 weeks. Treatment was well tolerated: Mild erythema and edema occurred in 100% and 98.1% of patients, respectively. No blistering, crusting, or hypo- or hyperpigmentation were observed. Patient satisfaction and self-confidence improved at both follow-up timepoints.

LIMITATIONS: No control group; reliance on image assessment; open-label design.

CONCLUSION: The seboselective 1726-nm laser is an effective and well-tolerated therapy for reducing moderate-to-severe facial acne for at least 1 year.

BACKGROUND: Gorlin syndrome (GS) is a rare genetic disorder characterized by a predisposition to developing numerous basal cell carcinomas (BCCs) throughout life. The absence of specific clinical guidelines for managing BCCs in GS has resulted in fragmented care and inconsistent treatment approaches.

OBJECTIVE: To develop evidence-based guidelines for managing BCCs in GS, addressing both clinical and psychosocial challenges.

METHODS: A multidisciplinary panel employed a modified Grading of Recommendations Assessment, Development and Evaluation approach, integrating systematic reviews, expert surveys, patient interviews, and Delphi consensus rounds to formulate recommendations.

RESULTS: The final guidelines include 47 recommendations spanning topical therapies, systemic treatments, surgical interventions, and multimodal strategies. Additional recommendations emphasize shared decision-making, comprehensive monitoring, and psychosocial support to address the chronic nature of BCCs in GS. Specific therapies, including hedgehog inhibitors and field treatments, are recommended to reduce surgical fatigue and enhance quality of life.

LIMITATIONS: Given the scarcity of GS-specific data, expert consensus informed several recommendations, highlighting the need for ongoing research to strengthen the evidence base.

CONCLUSION: These guidelines provide a structured framework for improving BCC management in GS, thereby enhancing clinical outcomes and patient quality of life. This process serves as a model for creating patient-centered guidelines in rare conditions with limited evidence.

Rosacea is a common, chronic, inflammatory disease of the skin, which predominantly (but not exclusively) affects the centrofacial region. Clinical features may include transient or persistent facial erythema, recurrent flushing, telangiectasia, papules, pustules, phymatous changes, and ocular disturbances. These can lead to significant physical and psychological burden and discomfort, which adversely affects a patient's quality of life (QoL). While current guidelines provide recommendations on treatment initiation and modification, there is a lack of information for long-term management and maintenance. The Rosacea-Expert Advice on Combined and Holistic approaches (REACH) group is an international group of experienced dermatologists, brought together to address these shortcomings. This paper summarizes discussions from three REACH Global Scientific Committee (GSC) meetings, with the objective to simplify the rosacea management pathway and ensure that healthcare professionals are aware of rosacea triggers, pathogenesis, risk factors, comorbidities, chronicity, patient satisfaction, monitoring, and treatment options. The REACH GSC developed a rosacea management pathway as a backbone for this publication-to advise on each step, including pitfalls to avoid, patient discussions to conduct, tools and guidelines to employ, and clinical factors to consider. Being able to discern all the clinical features of rosacea specific to each patient is imperative, from recognizing overriding signs and symptoms to understanding potential comorbidities and assessing impact on QoL. Clear and sensitive communication regarding these elements, and what outcomes are achievable, will help to optimize therapeutic management and foster a sense of patient empowerment and disease control. For patients, being able to engage in their own long-term care of symptoms, signs, and flares is critical. Deepening the understanding of the condition as a chronic, yet eminently manageable one, will help empower patients with rosacea and their dermatologists alike. The REACH GSC project was initiated and funded by Galderma.

BACKGROUND: Patients with psoriasis affecting a low percentage of their body surface area (BSA) are under-represented in clinical studies and may face substantial disease burden if high-impact sites are affected.

OBJECTIVES: To evaluate in a phase IIIb randomized placebo-controlled study (SPECTREM; NCT06039189) the efficacy and safety of guselkumab in participants with low BSA (2-15%), moderate [Investigator's Global Assessment (IGA) = 3] plaque psoriasis involving one or more high-impact site (scalp, face, genitals, intertriginous areas).

METHODS: Eligible participants were randomized 2 : 1 to receive guselkumab 100 mg or placebo at week 0 and week 4, then every 8 weeks. The primary endpoint was the proportion of participants achieving IGA 0/1 (cleared/minimal) at week 16. Major secondary endpoints included the proportion of participants achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90), IGA 0 and 100% improvement in PASI (PASI 100); mean percentage improvements from baseline to week 16 in BSA and PASI; and proportions of participants achieving site-specific IGA or Physician's Global Assessment (PGA) 0/1 among those with scalp, facial, genital or intertriginous site-specific IGA/PGA ≥ 3 at baseline.

RESULTS: Among the 338 randomized participants (guselkumab, n = 225; placebo, n = 113), mean (SD) baseline BSA was 7.6% (3.7) and PASI was 9.0 (3.8). At week 16, all primary and major secondary endpoints were met, with guselkumab demonstrating superiority vs. placebo (all P < 0.001) in the proportions of participants achieving IGA 0/1 (74.2% vs. 12.4%), IGA 0 (40.4% vs. 3.5%), PASI 90 (52.9% vs. 6.2%) and PASI 100 (32.4% vs. 2.7%), and mean percentage improvement from baseline in BSA (80.6% vs. 6.1%) and PASI (82.6% vs. 13.7%). Site-specific IGA/PGA 0/1 response rates for guselkumab vs. placebo were as follows: scalp 75.0% (n = 114/152) vs. 14.5% (n = 11/76); face 87.8% (n = 79/90) vs. 28.6% (n = 12/42); genital 78.0% (n = 64/82) vs. 37.5% (n = 15/40) and intertriginous 86.5% (n = 96/111) vs. 28.8% (n = 15/52). In the guselkumab and placebo groups, respectively, 37.8% and 39.8% experienced one or more adverse event; no new safety signals were identified.

CONCLUSIONS: Through week 16, guselkumab was effective and well tolerated in participants with low BSA, moderate plaque psoriasis with involvement of high-impact sites. Statistically significant improvements across multiple clearance measures, irrespective of baseline BSA, support the effectiveness of guselkumab across a broad range of patients.

BACKGROUND: Rocatinlimab is a T cell rebalancing therapy that inhibits and reduces the number of pathogenic T cells by targeting the OX40 receptor expressed on the surface of activated T cells. Two global phase 3 studies were performed to assess the efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in adults.

METHODS: ROCKET-IGNITE (IGNITE) and ROCKET-HORIZON (HORIZON) were 24-week randomised, double-blind, placebo-controlled phase 3 trials conducted in 19 countries each. Eligible patients were 18 years and older with confirmed atopic dermatitis (American Academy of Dermatology Consensus Criteria) diagnosed 1 year or longer before study entry with moderate-to-severe disease activity, defined by an Eczema Area and Severity Index (EASI) score of 16 and over, validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) or 4 (severe), and affected body surface area of 10% and above. In IGNITE, patients were randomly allocated in a 3:2:2 ratio to receive subcutaneous 300 mg rocatinlimab, 150 mg rocatinlimab, or placebo; in HORIZON, patients were randomised 3:1 to receive subcutaneous 300 mg rocatinlimab or placebo. Randomisation was stratified by baseline disease severity (vIGA-AD score of 3 vs 4) and geographical region (Japan vs non-Japan Asian countries vs rest of world). Across both trials, 24-week treatment was administered at weeks 0, 2, and 4 and then every 4 weeks thereafter with the last dose at week 20. The coprimary endpoints for both trials were EASI-75 response (≥75% improvement in EASI score from baseline) at week 24 and vIGA-AD score of 0 or 1 (defined as a score of 0 [clear skin] or 1 [almost clear skin], representing a ≥2-point improvement from baseline) at week 24. Rescue therapy use, including topical therapy, phototherapy, and systemic therapy, was permitted from day 1; all patients who received rescue therapy were considered non-responders for all visits after the first use of rescue therapy but could generally continue study treatment unless prohibited per protocol. Efficacy analyses were conducted in all randomised patients; safety analyses were conducted in all patients who received one or more dose of study treatment, with patients grouped according to actual treatment received. The trials were registered at ClinicalTrials.gov: ROCKET-IGNITE (NCT05398445) and ROCKET-HORIZON (NCT05651711).

FINDINGS: Between May 31, 2022, and June 12, 2024, 769 patients were randomised in IGNITE (two patients were enrolled under an earlier protocol before study re-design and excluded from the analysis; after the protocol update, 328 were included in the 300 mg rocatinlimab group; 217 in the 150 mg rocatinlimab group; and 222 in the placebo group) and between Dec 14, 2022, and Dec 12, 2023, 726 patients were randomised in HORIZON (543 in 300 mg rocatinlimab and 183 in placebo). Both trials met their coprimary endpoints. Rocatinlimab treatment resulted in statistically significant improvements in EASI-75 response in comparison with placebo at week 24 in IGNITE (138 [42%] of 326 patients on 300 mg rocatinlimab; 78 [36%] of 215 on 150 mg rocatinlimab; and 28 [13%] of 219 on placebo; percentage difference vs placebo: 300 mg rocatinlimab 29·5% [95% CI 22·3-36·1], p< 0·001 and 150 mg rocatinlimab 23·4% [15·4-30·9], p< 0·001) and HORIZON (rocatinlimab, 178 [33%] of 543 vs placebo, 25 [14%] of 183; percentage difference 19·1% [95% CI 12·4-25·2], p< 0·001). Statistically significant improvements with rocatinlimab treatment in comparison with placebo were also observed at week 24 for vIGA-AD score of 0 or 1 response in IGNITE (77 [24%] of 326 patients on 300 mg rocatinlimab; 41 [19%] of 215 patients on 150 mg rocatinlimab; and 19 [9%] of 219 patients on placebo; percentage difference vs placebo 14·9% [95% CI 8·8-20·6], p< 0·001 for 300 mg rocatinlimab and 10·3% [3·8-16·6], p=0·002 for 150 mg rocatinlimab) and HORIZON (105 [19%] of 543 for 300 mg rocatinlimab vs 12 [7%] of 183 for placebo; percentage difference 12·8% [95% CI 7·6-17·3], p< 0·001). The incidences of treatment-emergent adverse events were generally similar across rocatinlimab and placebo treatment groups in IGNITE and HORIZON. The most frequently reported adverse events in patients receiving rocatinlimab (defined as occurring in ≥4% of patients in any rocatinlimab treatment group and at a rate ≥2 times that of placebo) included pyrexia (105 [12%] of 870 for 300 mg rocatinlimab and 26 [12%] of 214 for 150 mg rocatinlimab), chills (48 [6%] of 870 and five [2%] of 214 for the 300 mg and 150 mg doses, respectively), and aphthous ulcers (38 [4%] of 870 and six [3%] of 214, respectively). Most events of pyrexia and chills were considered injection-related reactions; events were generally mild or moderate in severity and primarily occurred after the first dose. Serious adverse events were reported in 2% to 5% of patients in the rocatinlimab groups and 4% to 6% of patients in the placebo groups. No deaths were reported.

INTERPRETATION: Rocatinlimab treatment resulted in statistically significant and clinically meaningful improvements across clinical endpoints, including the coprimary endpoints of EASI-75 response and vIGA-AD score of 0 or 1, in comparison with placebo and had a clinically acceptable safety profile in adult patients with moderate-to-severe atopic dermatitis.

FUNDING: Amgen and Kyowa Kirin.

Introduction: In the ADORING 1 and 2 Phase 3 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis (AD). We present efficacy, safety, and tolerability outcomes from ADORING 3. Methods: Eligible patients from ADORING 1, ADORING 2, from a four-week maximal usage pharmacokinetics trial, and tapinarof-naive patients with mild AD, or moderate or severe AD, that did not meet inclusion criteria for ADORING 1 or 2, received tapinarof cream 1% QD for up to 48 weeks. Efficacy endpoints included achievement of complete disease clearance (Validated Investigator Global Assessment for Atopic Dermatitis™ [vIGA-AD™] score=0 [clear]), and clear or almost clear skin (vIGA-AD™=0 or 1). Safety and tolerability were assessed. Patients entering with vIGAAD™ ≥ 1 were treated with tapinarof until complete clearance (vIGA-AD™=0). Those entering with or achieving complete clearance discontinued tapinarof and were assessed for maintenance of clear or almost clear skin off-treatment (duration of treatment-free interval). Patients whose AD returned to mild (vIGA-AD™ ≥ 2) were re-treated until complete clearance was achieved. Results: In total, 728 patients enrolled; 83.0 percent were pediatric (2–17 years). Overall, 51.9 percent (378/728) achieved complete disease clearance, and 81.6 percent achieved clear or almost clear skin at least once in the trial. Mean duration of first treatment-free interval was 79.8 consecutive days (standard deviation: 81.4 days). No tachyphylaxis on either continuous or intermittent therapy was observed for up to 48 weeks. Most frequent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). Follicular events and contact dermatitis were mostly mild or moderate and associated with low discontinuations (1.0% and 0.4%, respectively). Tapinarof was well tolerated locally, even when applied on sensitive skin. Conclusion: Tapinarof cream monotherapy demonstrated a high rate of complete disease clearance in patients down to age 2 years with AD. After discontinuing tapinarof, patients maintained clear or almost clear skin for 79.8 consecutive days. Tapinarof was well tolerated over 48 weeks.

Introduction: Acne vulgaris is a common dermatologic condition and a leading dermatologic diagnosis in Black and Hispanic patients. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for the treatment of acne. In three published clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. The objective of these analyses was to determine the efficacy, safety, and tolerability of CAB in Hispanic participants of these studies. Methods: In one Phase 2 (NCT03170388) and two Phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at Week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data across all three studies were analyzed for participants who self-identified as Hispanic/Latino (herein referred to as Hispanic; n=90 CAB; n=57 vehicle gel). Results: At Week 12, over half of Hispanic participants achieved treatment success with CAB versus less than one-quarter with vehicle gel (56.2% vs. 18.4%; p<0.001). CAB treatment provided more than 75-percent reductions in inflammatory/noninflammatory lesion counts at Week 12 vs 56.4 percent and 45.0 percent, respectively, with vehicle (p<0.001, both). TEAE rates with CAB in the Hispanic population were similar to those in the overall study populations (27% vs. 24.6–36.2%). Most TEAEs were of mild-to-moderate severity, and discontinuations due to AEs were low (<4%). Mean cutaneous safety and tolerability scores (0=none to 3=severe) with CAB at all visits were less than one (mild), similar to the overall study populations. Hyperpigmentation scores decreased from baseline (0.6) to Week 12 (0.3) following CAB treatment. Conclusion: In Hispanic participants with moderate-to-severe acne treated with CAB, over half achieved treatment success and acne lesion reductions were reduced by more than 75 percent by Week 12, without any additional safety signals. These results, combined with those of previous post-hoc analyses in Black study participants, demonstrate that CAB is an efficacious, safe, and tolerable acne treatment for patients of different racial and ethnic groups.

Introduction: Treatments with fast and substantial acne clearance are highly desirable. While a three-pronged approach can increase treatment efficacy versus monotherapy or dual-combination therapy, it is unknown if triple-combination provides more rapid improvement. CAB gel—clindamycin phosphate (clin) 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1%—is the first fixed-dose, triple-combination acne topical. Since rapid/substantial acne improvements and fewer side effects can increase adherence, the efficacy and safety of CAB in the first four weeks of treatment was evaluated. Methods: In a Phase 2 (N=741; NCT03170388) and two Phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel; the Phase 2 study included three additional dyad arms: BPO/adapalene; clin/BPO; and clin/adapalene. Efficacy assessments included least-squares mean percent change from baseline in inflammatory and noninflammatory lesions. Cutaneous safety/tolerability assessments were graded from 0=none to 3=severe. Post-hoc analyses included percentages of participants with one-third and one-half acne lesion reductions. Results: At Week 4, CAB led to approximately 55 percent reductions from baseline in inflammatory acne lesions in the ph2 and pooled ph3 studies, significantly greater than vehicle (~40%) and its three dyads (ph2 range: 44.2-47.6%; p<0.05, all). The percentages of participants with one-third and one-half reductions of inflammatory lesions were significantly greater with CAB than vehicle and dyads (p<0.05, all). Similar trends were observed for noninflammatory lesions, though reductions were less pronounced. As expected for retinoids, transient increases from baseline to Week 2 in scaling, erythema, itching, burning, and stinging were observed for CAB, BPO/adapalene, and clin/adapalene, with mean scores ≤ 0.6 (1=mild); no trends in dyspigmentation were observed. Mean scores for all cutaneous assessments were highest for BPO/adapalene, indicating that adding a third product in the fixed-dose CAB gel formulation did not worsen tolerability. Conclusion: Acne lesion reductions were significantly greater with clin 1.2%/adapalene 0.15%/BPO 3.1% gel versus its dyads and vehicle gel as early as Week 4. More rapid efficacy with this first fixed-dose triple-combination acne product—coupled with its optimized formulation, once-daily dosing, and tolerability—might positively impact treatment adherence.

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious versus placebo and apremilast and was well tolerated in the global, 52-week, Phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials. At Week 52, patients could enroll in the ongoing POETYK long-term extension (LTE) (NCT04036435) trial and receive open-label deucravacitinib. Changes in blood laboratory parameters known to be associated with Janus kinase (JAK) 1,2,3 inhibitors were evaluated through four years of deucravacitinib treatment. Methods: Changes from baseline in lipid (cholesterol, triglycerides), chemistry (alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, creatine phosphokinase [CPK]), and hematology (hemoglobin, lymphocytes, neutrophils, platelets) parameters in the blood known to be affected by JAK1,2,3 inhibitors in clinical trials were evaluated through Week 208 (4 years; data cutoff, November 1, 2023). Treatment discontinuations due to laboratory abnormalities were assessed. Results: A total of 1,519 patients received at least one deucravacitinib dose (total exposure, 4392.8 person-years); 1,203 (79.2%) had at least 52 weeks and 542 (35.7%) had at least 208 weeks of continuous deucravacitinib exposure (median, 185 weeks). No trends or clinically meaningful mean changes from baseline were observed in any of the above laboratory parameters. In total, three patients discontinued treatment due to increased CPK, and one patient each discontinued due to lymphopenia, abnormal hepatic function, increased ALT, and increased AST. Discontinuations due to triglyceride elevations were not observed. Conclusion: In PSO-1/PSO-2/LTE, no trends or clinically meaningful mean changes from baseline were observed in lipid, chemistry, or hematology parameters, in contrast to signature changes (eg, increased cholesterol, creatinine, serum transaminases, CPK, cytopenias) observed with JAK1,2,3 inhibitors. Discontinuations due to laboratory abnormalities noted above were rare (n=7 events) through four years of deucravacitinib treatment. Results suggest deucravacitinib treatment does not warrant routine laboratory testing for all patients, in contrast with the requirements for JAK1,2,3 inhibitors, reflecting its selectivity for TYK2.

Introduction: ADapt (NCT05369403), an open-label, Phase 3b, 24-week study, evaluated the efficacy and safety of lebrikizumab (LEB) in patients with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab (DUPI). Patients must have discontinued DUPI due to inadequate response (non-response, partial response, or loss of response), intolerance or an adverse event (AE), or other reasons. Methods: Four or more weeks after discontinuing DUPI, patients received a 500mg LEB loading dose at baseline and at Week 2 followed by 250mg every two weeks through Week 16 (Q2W). At Week 16, responders (IGA 0 or 1 with ≥ 2-point improvement [IGA0,1] or EASI75 [primary endpoint]) received LEB 250mg once every four weeks (Q4W); other patients continued with 250mg Q2W. Q2W and Q4W data were pooled and analyzed as-observed and with nonresponder/multiple imputation (NRI/MI). Results: Among 86 enrolled patients, 56 percent discontinued DUPI due to inadequate response, 16 percent due to intolerance/AEs to DUPI, and 28 percent for other reasons. For all patients, at Weeks 16 and 24, respectively, proportions of patients achieving: 1) EASI75: 57.4 percent and 60.0 percent, as-observed; 50.7 percent and 52.8 percent NRI/MI; 2) IGA0,1: 38.7 percent and 38.2 percent, as-observed; 35.6 percent and 36.8 percent, NRI/MI; 3) Face-IGA 0: 42 percent and 49 percent, as-observed; 4) Pruritus NRS ≥ 4-point improvement 53.2 percent and 61.5 percent as-observed; 48.8 percent and 47.9 percent NRI/MI; and 5) DLQI ≥ 4-point improvement 83.0 percent and 83.0 percent as-observed. The safety profile was consistent with other LEB Phase 3 trials. Four patients who discontinued DUPI due to conjunctivitis did not report conjunctivitis with LEB. Additionally, 3.5 percent of patients reported treatment-emergent conjunctivitis. Conclusion: In DUPI-experienced patients, treatment of moderate-to-severe AD with LEB resulted in meaningful improvements in skin clearance, itch, and quality of life.

Hidradenitis Suppurativa (HS) is a chronic inflammatory disease characterized by painful nodules and sinus tunnels which significantly impacts quality of life. Diagnosis of HS is difficult and often delayed due to the lack of diagnostic tests, relying on clinical observation and patient history. The average diagnostic delay is between 7-10 years. The literature lacks substantial evidence on the impact of insurance status, family history, and comorbidities on diagnostic delays. Our study evaluated these and other previously studied factors' association with HS diagnostic delay at Henry Ford Hospital in Detroit. Data including age of HS onset, age of HS diagnosis, first degree family history, comorbidities and tobacco use history was extracted from the new patient intake forms at the HS specialty clinic from (January 2020 – March 2024) with demographics from chart reviews. Data from 228 records were analyzed. Diagnostic delay was defined as diagnosis over one year post-onset. A generalized additive model with non-linear regression was used to assess the association between each variable and average diagnostic delay. 228 records were reviewed, out of which 196 complete records were included in the analysis. Increased age (p=0.0329) and positive family history (p=0.0135) were associated with longer diagnostic delays after adjusting for confounders. Tobacco use revealed the longest delay (eight years). Sex was not significantly associated with diagnostic delay. Final analyses will include results for covariates including insurance status, comorbidities and average delay in years. This study will offer key insights into factors contributing to HS diagnostic delay.

Background: Optical Polarization Imaging (OPI) exhibits potential for indirectly determining basal cell carcinoma (BCC) margins via detection of peri-lesional dermal collagen disruption. Although the capability of OPI in BCC margin assessment prior to Mohs surgery was recently published, challenges remain in image acquisition and analysis leading to discrepancies between OPI and histopathology findings. This pilot study was to identify key aspects for optimal OPI image acquisition and analyses. Methods: OPI images were collected from 27 BCC lesions enrolled in an IRB approved study. Images were reviewed for quality and comparisons were made between OPI and histopathology, after the first Mohs layer, to identify limitations and areas of improvement to increase consistency. Results: The following were identified to improve image quality: avoidance of bubbles within the gel by applying gentle pressure, selecting relatively flat areas as curvature was resulting in pressure gradient, application of uniform pressure, and using appropriate exposure time. To improve image analysis, the following were identified: utilization of skin marker with color transparent in the blue channel, avoidance of, or adjustment to image processing algorithm to account for excessive vascularization, photodamage, or hair in the field of view. Conclusion: OPI remains a promising modality for indirect detection of BCC margin and could potentially be added to other direct tumor imaging modalities for increased specificity. OPI is a user-friendly, non invasive and time efficient imaging technique; however, further refinement of image acquisition and analysis methods, incorporating the respective criteria above in future studies are warranted to optimize its capabilities.

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In the phase 3b/4, PSORIATYK SCALP (NCT05478499) trial, deucravacitinib was superior to placebo at Week 16 in patients with moderate to severe scalp psoriasis, including those with more limited overall psoriasis.1 This analysis reports efficacy in overall body psoriasis by baseline total body surface area (BSA) involvement. Methods: Outcomes at Week 16, analyzed by BSA involvement of 3%-10% or >10%, included static Physician Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (sPGA 0/1) and adjusted mean change from baseline in PASI. Nonresponder imputation (binary outcomes) and modified baseline observation carried forward (continuous outcomes) were used for patients who had missing data. Analyses are post hoc; P values are nominal. Results: Baseline BSA-defined subgroups were 3%-10% (n=70 vs n=38) and >10% (n=33 vs n=13) for deucravacitinib vs placebo, respectively. Week 16 sPGA 0/1 response rates were comparable in 3%-10% and >10% BSA subgroups, with higher proportions among patients treated with deucravacitinib versus placebo (42.9% vs 5.3% and 57.6% vs 0%, respectively; P<0.001 for both). Similarly, decreases in adjusted mean PASI were greater with deucravacitinib than with both 3%-10% (−3.7 vs −1.0, respectively) and >10% (−13.2 vs −2.2) BSA subgroups (P<0.0001 for both). Conclusion: Deucravacitinib was efficacious in improving psoriasis in patients with a wide range of total BSA involvement.

Per-protocol response criteria can have limited ability to inform patient–healthcare provider dialogue as individual patient experiences may vary in the same responder population. This analysis aimed to assess individual patient trajectories of response to lebrikizumab using data from the ADvocate monotherapy trials. This analysis included patients with moderate-to-severe atopic dermatitis treated with 250-mg lebrikizumab every 2 weeks from the pooled ADvocate1 and ADvocate2 trials (modified intention-to-treat populations) during the induction period (weeks 0-16). A machine learning growth mixture model (GMM) was used to cluster patients by longitudinal trajectory of percent change in the Eczema Area and Severity Index (EASI). Proportions and rates of patients achieving EASI thresholds were evaluated. The GMM clustered patient response trajectories (N=564) into 2 groups. Cluster 1 (EASI responders) comprised 85% of patients (n=477), and on average achieved an EASI50 response at week 4 and with a continued response trajectory beyond EASI75. Cluster 2 (EASI nonresponders) comprised 15% of patients (n=87), with a mean EASI reduction of 24% at week 16. A GMM on Cluster 1 identified 3 subclusters (Clusters 1A/1B/1C), which varied by depth of and time to response and represented 38%, 32%, and 15% of patients, respectively. Patients in Clusters 1A, 1B, and 1C achieved mean EASI reductions of 93%, 84%, and 67%, respectively, at week 16. All clusters, including nonresponders in Cluster 2, had notable improvements in itch and quality of life. This analysis identified distinct EASI response patterns to lebrikizumab, which may help guide patient and healthcare provider expectations.

Background: Despite the growing minority population in the United States, there is no standardized method for incorporating skin color and its characteristics into clinical practice or research1. Skin classification aids in risk stratification, disease severity assessments, and monitoring adverse events, but most existing systems are limited (1). This study aims to identify components for an inclusive tool to diagnose and assess the severity of inflammatory and infectious conditions, evaluate disease course and treatment response, and classify participant categories in clinical research. Methods: A Delphi technique was utilized to transform expert opinion into group consensus through three survey rounds, meetings, and individual voting. A 66-item questionnaire scored with a 5-point Likert scale and 3 open-ended questions was distributed to a panel of SOCS dermatologists to gather opinions on skin type/color classification and assessment tools. Consensus for tool inclusion was defined as ≥80% agreement. Results: Twenty-two SOCS experts were invited to participate. Of these, twenty-one completed all three rounds and reached consensus on 21 statements. Critical consensus (≥70-79% agreement) was achieved for 7 statements, while 17 statements were excluded due to <70% agreement. 7 statements were selected for review based on panel members selecting “I don’t know/needs to be reviewed.” 100% consensus was reached on the need to validate the scale. Conclusions: Reliable tools for assessing dermatologic conditions in all skin types are essential. This study confirms that current classification tools are inadequate, and experts strongly agree on the need for a validated, inclusive tool for both clinical practice and research.