bluuebunny/crossref_metadata_2025 huggingface dataset:
A Novel Nutraceutical Gummy for Hair Regrowth in Women: A Case Series
Authors: Douglas Annyella , Ramani Leena , Hawkins Spencer , Leavitt Matt
Published: November 2024

Introduction:Hair loss is a common concern among women, with female pattern hair loss (FPHL) and telogen effluvium (TE) being the most prevalent types. At least 50% of women experience hair loss by age 50 [1]. Many patients turn to nutritional supplements, with one hair loss clinic reporting that up to 81% of their patients use supplements [2]. While various nutraceuticals have demonstrated clinical efficacy in hair regrowth [2], none have been evaluated in gummy form. This case series aims to assess the efficacy of a novel nutraceutical gummy containing a proprietary blend of NAD, pumpkin seed extract, taurine, pea protein, ashwagandha, saw palmetto, and other anti-inflammatory ingredients in promoting hair regrowth in women with FPHL and TE.
Procedure:Three women, aged 43, 52,64, with diagnoses of FPHL and TE, were included in this series. Each participant consumed two nutraceutical gummies daily for 2 or 3 months. One participant experiencing TE, also took oral minoxidil 1.25 mg daily. Baseline assessments included patient-reported outcomes related to hair shedding and photographic comparisons. Follow-up assessments were performed at 2 or 3 months. 
Results:All three women demonstrated noticeable improvements in hair density and a reduction in hair shedding by the 3-month mark. Participants also reported subjective improvements in hair quality, volume, and overall satisfaction with the product. No adverse effects were observed during the study period.
Conclusion:This case series suggests that the novel nutraceutical gummy may be an effective, well-tolerated option for promoting hair regrowth in women with FPHL and TE. This nutraceutical can be efficacious as a sole treatment and in conjunction with traditional hair loss medical therapy. These findings highlight the potential for a gummy formulation to provide an accessible, evidence-based treatment for hair loss. Further studies with larger sample sizes are ongoing to validate these results.
Bimekizumab Efficacy and Safety Through 2 years in Patients with Hidradenitis Suppurativa: Results from the Phase 3 BE HEARD I&II trials and Open-Label Extension BE HEARD EXT
Authors: Zouboulis Christos C , Garg Amit , Sayed Christopher , Jemec Gregor , Kokolakis Georgios , Ingram John , Morita Akimichi , Dokhe Pratiksha , Pansar Ingrid , Rolleri Robert , Crater Christina , Datye Asim , Kimball Alexa B.
Published: November 2024

Introduction: Interleukin (IL)-17F and IL-17A play a role in the immunopathogenesis of hidradenitis suppurativa (HS).1–3 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits IL-17F in addition to IL-17A leading to clinically meaningful improvements in patients (pts) with HS.4,5 Here, BKZ efficacy and safety data (OC) are presented over 2 years (96 weeks [wks]) for the pooled BE HEARD I&II (BHI&II) trials and BE HEARD EXT (BHEXT).5,6
Procedure/Study: In BHI&II, pts with moderate to severe HS were randomized 2:2:2:1 (16wk-initial/32wk-maintenance) to BKZ 320mg every 2 wks (Q2W)/Q2W, BKZQ2W/Q4W, BKZQ4W/Q4W or placebo/BKZQ2W.5 Wk48 completers could enroll in BHEXT and receive open-label BKZQ2W or BKZQ4W based on ≥90% HS Clinical Response (HiSCR90; averaged from Wks36/40/44). We report HiSCR50/75/90/100 rates, percentage change from baseline (%CfB, mean±SD) in International HS Severity Score System (IHS4) and draining tunnel (DT) count, and Dermatology Life Quality Index (DLQI) 0/1 achievement at Wks48/96 for patients randomized to BKZ in BHI&II and entered BHEXT (BKZ Total, observed case). Safety outcomes reported for pts who received ≥1 BKZ dose across BHI&II/BHEXT.
Results: 556 pts randomized at baseline to BKZ in BHI&II completed Wk48 and entered BHEXT; 446 pts completed Wk96. At Wk48, HiSCR50/75/90/100 was achieved by 79.9/64.0/42.3/30.2% of pts; responses improved to Wk96: 85.4/77.1/57.6/44.2%. Baseline IHS4 was 35.6±31.5; %CfB at Wk48/96 was –70.3±39.6/−79.8±28.1%. Baseline DTs were 3.8±4.3; the %CfB at Wk48/96 was −57.5±72.9%/−73.7±45.7%. Baseline DLQI was 11.0±6.8; 27.4% (151/551) of pts achieved DLQI 0/1 at Wk48 and 33.9% (149/439) at Wk96. Over 2 years, 917/995 (248.9/100 pt years [PY]) pts experienced a treatment-emergent adverse event (TEAE). Serious TEAEs were reported in 122 (7.2/100 PY) pts; 109 (6.3/100 PY) pts discontinued due to a TEAE. Serious infections occurred in 33 (1.9/100 PY) pts. Safety data were comparable with BHI&II.5
Conclusion: In pts treated with BKZ, clinically meaningful improvements in efficacy outcomes observed at 1 year, including the HiSCR 75/90/100, IHS4, and DT count endpoints, were maintained to 2 years; improvements in quality of life were maintained. No new safety signals were observed; the safety profile over 2 years was consistent with BHI&II and BKZ studies in other indications.5,7–9
Bimekizumab Effect on the Need for Concomitant Rescue Interventions by HiSCR Response Level in Patients with Moderate to Severe Hidradenitis Suppurativa from BE HEARD I&II
Authors: Bechara Falk G. , Forman Seth , Garg Amit , Guillem Philippe , Van der Zee Hesel H. , Giamarellos-Bourboulis Evangelos J. , Morita Akimichi , Lukowski Bartosz , Rolleri Robert , Dokhe Pratiksha , Tilt Nicola , Hamzavi Iltefat
Published: November 2024

Introduction: Hidradenitis suppurativa (HS) is a chronic, systemic, inflammatory skin disease characterized by deep, painful lesions that negatively impact patients’ (pts’) quality of life.1 These lesions are difficult to treat and require multifaceted treatment, including the need for rescue interventions alongside conventional therapy.1 Bimekizumab (BKZ) is a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F in addition to IL-17A.2 Here, the relationship between increasingly stringent HS Clinical Response (HiSCR) levels achieved with BKZ and the proportion of pts not requiring rescue concomitant interventions is investigated.Procedure/Study: Pooled data are presented from the phase 3 BE HEARD I&II trials maintenance treatment period (Weeks [Wks]16–48).3 Pts were randomized 2:2:2:1 (initial/maintenance treatment period) to BKZ 320 mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. Data for the individual BKZ randomization arms and pooled across these arms (BKZ Total) are reported. BKZ-randomized pts were grouped by achievement of mutually exclusive HiSCR levels (<50% improvement from baseline [<HiSCR50]; HiSCR50–<75; HiSCR75–100) at Wk16. The incidence of pts not requiring any concomitant rescue interventions during the maintenance treatment period, including medical (antibiotics, analgesics) and procedural (incision/drainage, intralesional triamcinolone injection) interventions, are reported. Data reported as observed case.
Results: Overall, 868 pts were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), or BKZ Q4W/Q4W (N=288). In BKZ Total, 76.0%/83.2%/89.1% of pts in the HiSCR<50/50–<75/75–100 bands did not receive rescue intervention through Wks16–48, demonstrating a numerical increase with increasing HiSCR bands. Comparable trends across HiSCR<50/50–<75/75–100 bands were observed in pts receiving BKZ Q2W/Q2W (79.8%/90.0%/90.9%), BKZ Q2W/Q4W (75.0%/78.3%/89.0%) or BKZ Q4W/Q4W (73.3%/81.4%/87.1%). Similar trends were observed from the lowest to highest HiSCR bands when separating into any medical or procedural interventions.
Conclusion: Overall, the majority of BKZ-randomized pts did not require any concomitant rescue medical or procedural interventions through Wks16–48 and the proportions of these pts increased with increasingly stringent HiSCR bands. These data highlight the additional value to pts of a decreased need for concomitant rescue interventions when they achieve higher HiSCR response levels. 
References: 1. Zouboulis CC. J Eur Acad Dermatol Venereol 2015;29:619–44; 2. Adams R. Front Immunol 2020;11:1894; 3. Kimball AB. Lancet 2024;403:2504–19.
Bimekizumab cumulative clinical benefit in patients with moderate to severe hidradenitis suppurativa through 1 year of the BE HEARD I&II phase 3 trials
Authors: Garg Amit , Armstrong April , Sofen Howard , Martorell-Calatayud Antonio , Podda Maurizio , Nomura Toshifumi , Wiegratz Susanne , Lambert Jérémy , Rolleri Robert , Tilt Nicola , Zouboulis Christos C
Published: November 2024

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease which significantly impacts health-related quality of life.1 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.2 ere, the cumulative benefit of BKZ treatment on HS clinical response (HiSCR) through 16 and 48 weeks (wks) is reported using area under the curve (AUC) analyses.Procedure/study: Pooled data from BE HEARD I&II included an initial (Wks0–16) and maintenance treatment period (Wks16–48).3 Randomization: 2:2:2:1 (initial/maintenance) BKZ 320mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. HiSCR50/75/90 response was achieved at a given visit if there was ≥50/75/90% reduction in the total abscess/inflammatory nodule count with no increase from baseline in abscess or draining tunnel count. Cumulative clinical benefit estimation: total AUC through Wk48 for HiSCR50/75/90 achievers. Calculation of estimated number of days patients achieved each response: proportion of total possible AUC for each outcome multiplied by total number of days in the period (Wks0–16: 112 days, Wks0–48: 336). Data are reported as observed case, where N represents number of patients with a non-missing lesion count assessment in the given week, and percentages are calculated accordingly (i.e. where data recorded after an intercurrent event are included).Results: Overall, 1,014 patients were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), BKZ Q4W/Q4W (N=288) and PBO/BKZ Q2W (N=146). Through 16wks, the total number of days patients achieved HiSCR50 was almost double in BKZ Q2W/Q2W (47 days), BKZ Q2W/Q4W (49), and BKZ Q4W/Q4W (47) groups vs PBO (27). To Wk16, the total number of days patients achieved HiSCR75/90 was at least double in the BKZ groups vs PBO. To Wk48, total number of days with HiSCR50 achievement: BKZ Q2W/Q2W, 211; BKZ Q2W/Q4W, 212; BKZ Q4W/Q4W, 206 vs PBO/BKZ Q2W, 178. Comparable results were observed for HiSCR75/90 at Wk48, with BKZ groups maintaining higher responses vs PBO. Conclusion: High levels of cumulative clinical benefit were observed for patients on BKZ through Wk16; benefits increased substantially through Wk48. The cumulative benefit of BKZ through 48wks was evident for patients receiving continuous BKZ and PBO switchers. The total number of days of clinical outcome achievement remained higher in those on continuous BKZ vs PBO switchers. These results demonstrate the rapid, high-level and durable responses that can be obtained with BKZ.
Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by blue light in the treatment of facial cutaneous squamous cell carcinoma in situ
Authors: Chaudry Aysham , Marrero-Perez Angelica , Vanaria Robert , Bhupalam Vishnu , Nestor Mark
Published: November 2024

Background: Cutaneous squamous cell carcinoma in situ (isSCC) is a common skin cancer occurring from sun exposure and often appears on the face.  Treatment is primarily surgical but less invasive treatments are desirable. Currently, aminolevulinic acid for photodynamic therapy (ALA-PDT) is approved in the US and Canada for the treatment of single and multiple non-hyperkeratotic actinic keratoses of the face and scalp. This study evaluated the safety, tolerability, and efficacy of ALA-PDT for treatment of facial isSCC.Methods: Thirty-two patients with biopsy-confirmed isSCC on the face were recruited. Lesions 0.4–1.3 cm in diameter were included. Per the actinic keratosis treatment protocol, the lesion was debrided with a 4 x 4 gauze and ALA 20% topical solution was applied to the lesion and adjacent skin and incubated for 18–24 hours, followed by blue light therapy 16 minutes 40 seconds at 10 J/cm2. Patients underwent two treatments with ALA-PDT spaced 28 +/- 3 days apart. The area of the original lesion was excised eight weeks following the second treatment for histopathological assessment. The primary efficacy endpoint was the complete absence histologically of the isSCC at end of treatment. The secondary efficacy endpoint was the achievement of clinical clearance of the skin lesion. Safety assessment was done through adverse events and local skin reactions (LSRs; erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) and site pain within 15 minutes of each treatment session.Results: Of the 32 patients enrolled, two did not complete the study. No residual SCCis was detected in 30/30 (100%) patients. Clinical clearance was achieved in 30/30 (100%) of the patients by the end of treatment. None of the patients experienced related adverse events and only 2/30 (5%) experienced an AE of hypertension and was considered to be unrelated. The most common LSRs were erythema and scaling and were primarily mild, seen to occur immediately after both treatments and diminished over time. The average median ± SD immediate post-treatment pain score was 2.56 ± 2.15 on the VAS scale.Conclusion: The ALA-PDT protocol outlined in this study appears to be a very effective, safe and well-tolerated treatment option for isSCC on the face.
Pilot study utilizing short contact protocols for treatment of actinic keratoses (AK) with ALA gel-red light photodynamic therapy (PDT)
Authors: Johnson Jessica , Hanna Jackson , Nowacki Amy , Anand Sanjay , Shen Alan , Maytin Edward
Published: November 2024

Background: Red light photodynamic therapy (PDT) is an effective option for actinic keratosis (AK) lesions. However, stinging pain during illumination limits utility.
 
Objective:  To compare three modified red-light PDT regimens (short incubation, whole-face application, no occlusion) and to determine whether these can reduce pain yet still provide significant AK lesion clearance.
 
Methods: Patients in this randomized clinical trial (n = 30) were randomized into one of three groups [incubation with 10% ALA gel, illumination with red-light]: Group A: 10 min, 20 min (75 J/cm2); Group B: 20 min, 10 min (37 J/cm2); Group C: 1 hour, 10 min (37 J/cm2). Two PDT treatments were administered 8 weeks apart. Lesions were counted at each visit, and pain was recorded on a scale from 0 – 10.
 
Results: Patients Groups A and B (shorter incubations) experienced significantly less pain during illumination than Group C.  After one treatment, the AK lesion reduction in Group A (59%) was statistically non-inferior to Group C (43%), with a noninferiority margin of ±15%. Final lesion counts after two PDT treatments showed a reduction from baseline by 82% in Group C, 76% in Group A, and 74% in Group B. Groups A and B did not meet the statistical non-inferiority endpoint relative to Group C after two treatments.
Limitations: Small sample size, which limited the ability to reach statistical significance after 2 PDT treatments.
 
Conclusion: Two short/modified red light PDT regimens were essentially painless, and all three provided AK lesion clearances comparable to conventional regimens.
Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial
Authors: Merola Joseph , Strober Bruce , Gottlieb Alice , Mostaghimi Arash , Hawkes Jason , Guercio Jason , Tang Ming , Thoma Christian , Lebwohl Mark
Published: November 2024

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients switched from a small-molecule systemic therapy at randomization when treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Within the FDA approved spesolimab regimen group, the average BSA for patients who stopped a systemic medication for GPP (Total N=22; acitretin = 13, cyclosporine = 7, methotrexate = 1, acitretin/methotrexate = 1) was 11.1 at baseline, decreasing to 8.2 at Week 4, 6.4 at Week 16, and then ending at 3.6 at Week 48. Total BSA involvement decreased over the 48 weeks of the trial in spesolimab-treated patients who stopped an off-label systemic medication for GPP at randomization.
Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial
Authors: Mostaghimi Arash , Strober Bruce , Merola Joseph , Gottlieb Alice , Elewski Boni , Guercio Jason , Tang Ming , Thoma Christian , Lebwohl Mark
Published: November 2024

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients diagnosed <5 vs ≥5 years prior to enrollment when treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Within the FDA approved regimen spesolimab group, average BSA for patients diagnosed with GPP for <5 years (N=13) was 14.7 at baseline, 15.0 at Week 4, then decreasing to 11.7 at Week 16, and then to 5.0 at Week 48. For patients diagnosed with GPP for ≥ 5 years (N=17) the values were 12.3 at baseline, decreasing to 7.0 at Week 4, increasing slightly to 7.6 at Week 16, and decreasing to 4.1 at Week 48. Total BSA involvement decreased over the 48 weeks of the trial in spesolimab-treated patients regardless of whether they were early (< 5 years) or late (≥ 5 years) in their disease course. This finding demonstrates the efficacy of spesolimab in controlling GPP consistently for patients with various lengths of disease history.
Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial
Authors: Strober Bruce , Merola Joseph , Gottlieb Alice , Mostaghimi Arash , Hsiao Jennifer , Guercio Jason , Tang Ming , Thoma Christian , Lebwohl Mark
Published: November 2024

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Total BSA improved continuously under spesolimab treatment (13.3% at baseline, 10.6% at Week 4, 9.4% at Week 16, ending at 4.5% at Week 48). Continuous treatment with spesolimab SC improved BSA from 13% to 5% at the end of the trial. These findings suggest a role of spesolimab in improving area of involvement as measured by BSA.
Four-weekly dosing intervals with subcutaneous spesolimab appear to be required for optimal prevention of generalized pustular psoriasis flares: Data from the EFFISAYIL® 2 and EFFISAYIL® ON trials
Authors: Thaci Diamant , Morita Akimichi , Strober Bruce , Torres Tiago , Pinter Andreas , Marzano Angelo , Krueger James , Tang Ming , Hofmann Patrick , Thoma Christian , Lebwohl Mark
Published: November 2024

Generalized pustular psoriasis (GPP) is a rare chronic skin disease characterized by recurrent, acute, and often life-threatening flares of widespread neutrophilic sterile pustules and systemic inflammation. Spesolimab, an anti-interleukin-36 receptor antibody, is approved in adults and adults and pediatric patients 12 years of age and older and weighing at least 40 kg, as a subcutaneous dosage for treatment of GPP when not experiencing a flare, and as an intravenous dosage for GPP flare treatment. In Effisayil 2, a randomized, placebo-controlled trial (NCT04399837), subcutaneous spesolimab was superior to placebo and well tolerated for flare prevention when administered as a 600-mg subcutaneous loading dose followed by 300 mg every 4 weeks (q4w) over 48 weeks. In Effisayil 2, 3/30 (10.0%) patients receiving subcutaneous spesolimab 300 mg q4w had flares, and there were no flares after Week 4 until the end of the study. We assessed the effect on flare recurrence of a longer (q12w) interval between subcutaneous spesolimab doses in Effisayil 2 and Effisayil ON (NCT03886246), an ongoing open-label extension trial. Flares were defined as a ≥2-point increase in GPP Physician Global Assessment total score with pustulation subscore of ≥2, or intravenous spesolimab or standard of care treatment due to GPP worsening.
In Effisayil 2, 9/31 (29.0%) patients who received subcutaneous spesolimab 300 mg q12w had a flare; of those, 7/9 (77.8%) experienced a flare before their second subcutaneous dose (Week 12), and 5/7 (71.4%) flares occurred during Weeks 4–12, indicating the need for q4w dosing. In Effisayil ON, 36/108 (33.3%) patients who started q12w dosing were either escalated to a q4w regimen (n=24) or experienced a flare (n=12).
These observations suggest that subcutaneous spesolimab 300 mg q4w is the optimal dosing regimen for prevention of GPP flares.
Dermal and Systemic Pharmacokinetics of Oral DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) vs Oral Doxycycline 40 mg in Healthy Subjects
Authors: Hebert Adelaide A. , Sidgiddi Srinivas
Published: November 2024

Dermal and Systemic Pharmacokinetics of Oral DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) vs Oral Doxycycline 40 mg in Healthy Subjects
Adelaide A. Hebert, MD,1 Srinivas Sidgiddi, MD2
1UTHealth Houston McGovern Medical School, Houston, TX; 2Journey Medical Corporation, Scottsdale, AZ
Introduction: A modified-release, low-dose formulation (DFD-29) of minocycline hydrochloride (HCl) is under investigation for the treatment of   rosacea. This Phase 1 study compared the dermal and systemic pharmacokinetics of DFD-29 (minocycline HCl, 40 mg) and doxycycline 40 mg in healthy, adult subjects.
Methods: This randomized, open-label, single-center, parallel-group study evaluated the systemic and dermal pharmacokinetics of once-daily administration of oral DFD-29 40 mg capsules or oral doxycycline 40 mg for 21 days in healthy adult volunteers. On Day 1, subjects received the assigned study drug under fasting conditions. Blood was sampled before drug administration, every 30 minutes for 4 hours, hourly for 4 hours, and 12 and 24 hours post dose. Dermal interstitial fluid (ISF) was sampled using three open-flow microperfusion probes before dosing, hourly for 8 hours, and at 11-12, 15-16, and 23-24 hours post dose. After discharge, subjects continued to take assigned study drug once daily through Day 21, when they returned to the center and underwent the same procedures as on Day 1. Safety was evaluated by monitoring adverse events (AEs), vital signs, and laboratory tests.
Results: A total of 24 subjects were randomized and completed the study. On Day 1, mean plasma Cmax levels with DFD-29 (382.8 ng/mL) and doxycycline (405.9 ng/mL) were comparable (Pr > 0.716). By Day 21, mean plasma Cmax had nearly doubled with doxycycline but remained constant with DFD-29 (701.9 vs 337.7 ng/mL; Pr > 0.037). Mean plasma AUC was also significantly greater with doxycycline than with DFD-29 at Day 21 (6074.8 ng.hr/mL vs 3957.6 ng.hr/mL, Pr > 0.013). In contrast, mean dermal Cmax concentrations were numerically higher with DFD-29 (40 mg) than doxycycline at Day 1 (109.7 vs 81.5 ng/mL; Pr > 0.117) and Day 21 (125.7 vs 114.7 ng/mL; Pr > 0.681). The mean dermal AUC at Day 1 also was greater with DFD-29 than with doxycycline (1412.29 ng.hr/mL Vs 1088.55 ng.hr/mL, Pr > 0.213), and at Day 21 it was similar in the two groups (1604.77 ng.hr/mL for DFD-29 and 1573.63 ng.hr/mL for doxycycline, Pr > 0.954). Both DFD-29 and doxycycline 40 mg were well tolerated by the healthy volunteers.
Conclusion: Minocycline from DFD-29 with its modified-release formulation provides higher dermal concentration than doxycycline from Day 1 onwards at a similar dose. The higher concentration from Day 1 at the site of action is expected to translate into a clinically meaningful impact in the treatment of patients with rosacea.
This study and abstract are funded by Journey Medical Corporation.
Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity
Authors: Gold Michael , Lain Edward (Ted) , Harper Julie C , Baldwin Hilary , Stein Gold Linda , Guenin Eric
Published: November 2024

Introduction: Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical treatment approved for acne. These analyses assessed efficacy and safety of CAB gel by baseline acne severity vs component dyads and branded ADAP/BPO gel.
Methods: These post hoc analyses used data pooled from two phase 2 and two phase 3, double-blind, 12-week studies (NCT03170388, NCT04892706, NCT04214639, NCT04214652). Eligible participants aged ≥9 years (≥12 years in NCT04892706) were randomized to once-daily CAB or vehicle gel. One phase 2 study included dyad combinations of CAB’s active ingredients: ADAP/BPO, CLIN/BPO, and CLIN/ADAP. The other phase 2 study included a head-to-head comparison of CAB gel and branded ADAP 0.3%/BPO 2.5% gel. Efficacy assessments included least-squares mean percent change from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score [EGSS] and clear/almost clear skin). Safety assessments included treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability. Participants were categorized by baseline disease severity: moderate (EGSS = 3; n=1557) or severe (EGSS = 4; n=230).
Results: After 12 weeks, inflammatory lesion reductions in participants with moderate acne were significantly greater with CAB (77.1%) than vehicle (54.1%; P<0.001), the 3 dyads (range, 64.4-69.4%; P≤0.001, all), and branded ADAP/BPO (72.8%; P<0.05). In the severe group, inflammatory lesion reductions with CAB (74.5%) were significantly greater than vehicle (44.4%; P<0.001) and 2 dyads (ADAP/BPO 63.9%, CLIN/BPO 61.3%; P<0.05), and similar to branded ADAP/BPO and CLIN/ADAP (75.4%/73.7%). Reductions in inflammatory lesions were greater than noninflammatory. Over half of CAB-treated participants with moderate disease achieved treatment success at week 12 (53.9% vs 19.5% vehicle; P<0.001), significantly greater than approximately one-third treated with dyads (range, 31.5-35.3%) or branded ADAP/BPO (38.1%; P≤0.001, all). Only CAB and CLIN/ADAP demonstrated significantly greater treatment success rates than vehicle in participants with severe acne at week 12 (30.9% and 34.0% vs 9.0%, respectively, P<0.05). Across all groups, most TEAEs were of mild to moderate severity. Mean cutaneous safety/tolerability scores were ≤1 (1 = mild) across severity groups.
Conclusions: CAB gel demonstrated efficacy and safety in participants with both moderate and severe acne. Acne improvements with CAB were superior to the 3 dyads tested and branded ADAP/BPO in participants with moderate acne and generally numerically greater in participants with severe acne. To our knowledge, these analyses of combination topical acne treatments include data from the only double-blind, vehicle-controlled, head-to-head study to date.
Funding: Ortho Dermatologics.
Environmental Impact and Sustainability Associated with the Practice of Dermatology
Authors: Vanaria Robert , Bhupalam Vishnu , Marrero-Perez Angelica , Chaudry Aysham , Awad Nardin , Nestor Mark
Published: November 2024

Purpose: The environmental impact of the practice of medicine including dermatology can be significant, driven by a growing and aging population that increasingly demands medical resources. This review explores the environmental effects of the practice of dermatology and identifies actionable solutions to reduce negative environmental impacts.
Methods: A PubMed search was conducted using the terms (“environmental impact” OR
“sustainability”) AND “dermatology.” Results were screened to include English-only articles between 2018 - 2024 and excluded duplicates. Further exploration of dermatology’s environmental effects was enhanced through citation tracking and additional PubMed searches.
Results: A total of 25 articles were included based on relevance and search terms and an additional 21 were added. Results were categorized into six categories for data representation. Patient travel was the largest contributor to negatively impact the environment, followed by waste management practices, journal publication and written patient material, and traveling to medical conferences. The environmental impact of pharmaceuticals, including topicals, is also notable. Potential sustainable alternatives include teledermatology, more appropriate waste production and segregation, and electronic versus printed formats and more virtual conferences. Additionally, dermatologic disease evolves in response to a changing environment, with new data indicating epidemiological shifts due to climate change. More sustainable practices within dermatology also have the potential to cut total overhead expenses.
Conclusions: Clinical and surgical subspecialties, specifically dermatology, can contribute significantly to environmental pollution, leading to environmental and financial impacts, but implementing simple, documented methods can reduce their ecological footprint and provide potential financial benefits.
Dupilumab Improves Patient-Reported Outcomes as Early as 1 Month among Adults with Prurigo Nodularis in Clinical Practice: Initial Results from the RELIEVE-PN Study
Authors: Kwatra Shawn , Thomas Ryan , Bahloul Donia , Zahn Joseph , Arshad Samreen , Martins Bruno , Yang Min , Liu Jiaxuan , Ho Allister , Elmariah Sarina
Published: November 2024

Introduction: Dupilumab is a monoclonal antibody approved in the United States (US) for patients aged ≥18 years with prurigo nodularis (PN). This analysis evaluated the real-world initial impact of dupilumab therapy on symptoms and treatment satisfaction among US adults with PN. Methods: RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adult patients with PN. Adults with PN were recruited through the US dupilumab patient support program and surveyed before (baseline) and 1 month after dupilumab initiation. PN symptoms over the last 7 days were assessed using the worst-itch numeric rating scale (WI-NRS), average-itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS (range 0 [no symptom] to 10 [most severe symptom] for all). Treatment satisfaction with current therapy was evaluated using a 7-point Likert scale from “extremely satisfied” to “extremely dissatisfied”. Results: Of 84 patients (mean age, 57.5 years; 79.8% female; 83.3% White) completing the baseline survey and initiating dupilumab, 62 (mean age, 56.4 years; 77.4% female; 83.9% White) completed the Month 1 survey. At baseline, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning/tingling NRS were 7.70 (2.24), 6.45 (2.25), 5.06 (2.87), and 5.51 (3.02), respectively. By month 1, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS improved to 5.56 (2.89), 4.35 (2.23), 3.40 (2.46), and 3.76 (2.60), respectively (p<0.001 for all). Additionally, significantly more patients reported they were satisfied with current PN treatment(s) at 1 month after dupilumab treatment initiation vs prior to starting dupilumab (77.4% vs 13.1%; p<0.001). Conclusion: Early results from the RELIEVE-PN study demonstrate improvement in symptoms and patient satisfaction with therapy as early as 1-month from treatment initiation of dupilumab. Further comparative research is needed to confirm these findings.
Acknowledgment: Research was funded by Sanofi and Regeneron Pharmaceuticals Inc.
Volumetric analysis of maxillary sinus and assessment of various sinonasal anatomic variants on multi-detector computed tomography (MDCT) and their association with chronic rhinosinusitis
Authors: Taneja Aman , Malhotra Ankur , Chandak Shruti , Jain Swasti , Taneja Arpit , Arora Deepti , Laxmi Swarna , Pandey Aishwarya
Published: November 2024

Objectives:

The study aimed to evaluate the relationship between maxillary sinus volume and various sinonasal anatomical variants, as detected by multi-detector computed tomography, and their associations with chronic rhinosinusitis (CRS).

Material and Methods:

A case–control study was conducted with 103 patients presenting with chronic sinonasal symptoms (cases) and 50 asymptomatic individuals (controls). A 128-slice computed tomography scanner was used to measure maxillary sinus volume and assess anatomical variants, such as a deviated nasal septum (DNS), concha bullosa (CB), and agger nasi cells. Exclusion criteria included previous sinonasal surgery, malignancy, craniofacial trauma, and lack of consent. Statistical analysis was performed using t-tests for continuous variables and Chi-square tests for categorical data. Receiver operating characteristic curve analysis was utilized to determine a DNS angle cutoff for predicting CRS.

Results:

Anatomical variants were significantly more frequent in cases than in controls. The left-sided DNS was predominant in cases, while the right-sided DNS was more common in controls. The mean DNS deviation angle was notably larger in cases (10.84° ± 7.87) than in controls (5.55° ± 5.02). Maxillary sinus volume was significantly smaller in cases (9.69 cc on the left side and 10.23 cc on the right side) compared to controls (18.57 cc and 18.46 cc, respectively), with female patients exhibiting smaller volumes than males. Agger nasi cells were detected in 51.5% of cases versus 8.0% of controls. A strong association was found between CB and contralateral DNS. The optimal DNS deviation angle cutoff for predicting CRS was identified as 12.7°.

Conclusion:

This study shows that CRS is linked to smaller maxillary sinus volumes, with males having larger sinus volumes than females. A DNS and larger deviation angles were associated with a higher risk of sinus inflammation, with angles over 12.7° predicting the onset of the condition. The presence of CB and agger nasi cells also contributed to the development of CRS.
ИНТЕГРАЦИЯ ЦЕЛЕЙ УСТОЙЧИВОГО РАЗВИТИЯ В РЕГИОНАЛЬНОЕ СТРАТЕГИРОВАНИЕ
Authors: Т.М. Тишкина
Published: November 2024

В статье рассмотрена интеграция целей устойчивого развития в региональную систему стратегического планирования Республики Мордовия. Основой оценки готовности данной системы к реализации положений концепции устойчивого развития стали следующие критерии: включенность (учет) задач устойчивого развития в региональные стратегические документы; взаимодействие государственных органов власти между собой и другими акторами в процессе стратегического планирования устойчивого развития региона; влияние целей устойчивого развития на формы участия региона в межрегиональном развитии; региональные интересы и приоритеты в содействии межрегиональному развитию; коммуникационная политика в сфере реализации задач устойчивого развития; наличие и содержание методологического обеспечения деятельности субъектов стратегирования в сфере устойчивого развития. Выявлено, что региональная система стратегического планирования устойчивого развития не сформирована, однако отдельные ее элементы являются достаточно работоспособными. В статье сформулированы рекомендации о тех шагах, которые должны быть сделаны, чтобы из отдельных разрозненных частей построить целостную систему.
УПРАВЛЕНИЕ ПРИГРАНИЧНЫМИ РЕГИОНАМИ В ЗАРУБЕЖНЫХ СТРАНАХ: НА ПРИМЕРЕ ФЕДЕРАТИВНОЙ РЕСПУБЛИКИ ГЕРМАНИИ
Authors: В.О. Ооржак
Published: November 2024

Статья посвящена изучению и анализу методов и подходов в зарубежных странах, к проблемам развития приграничных регионов, роль которых как зоны интеграции возрастает в эпоху глобализации. Актуальность данного вопроса напрямую связано с тем, что эффективность страны складывается из управления отдельными регионами, в том числе приграничными, депрессивными, которые входят в ее состав. Целью данной работы является исследование систем и методов регионального управления, том числе с приграничными регионами на примере Федеративной Республики Германии, в контексте современной модели управления приграничными регионами Евросоюза, создания еврорегионов. Решались задачи, по изучению опыта данной страны, принимая во внимание подходящие для данной ситуации методики по улучшению качества управления, регулирования и адаптирования их под нашу страну. Сделан вывод: Опыт Федеративной Республики Германии свидетельствует, что разумное использование преимуществ приграничного положения дает мощный импульс для развития даже самых неблагополучных приграничных территорий. Такой опыт управления приграничными регионами, вполне могло бы быть адаптированными в приграничных регионах южной Сибири России, с учетом особенностей каждого из них, в частности Республики Тыва, даже в современных условиях.
ЭКОНОМИКА ЗАМКНУТОГО ЦИКЛА И ЕЕ РАЗВИТИЕ В СТРАНАХ ЕВРОПЕЙСКОГО СОЮЗА
Authors: Ю.А. Акимова
Published: November 2024

Аннотация В связи с переходом на путь устойчивого развития многие страны, отдельные компании и производители задумываются о возможностях и перспективах внедрения циклической модели (модели замкнутого типа). Она позволяет производить больше с меньшими затратами сырья, удерживать баланс потребления продукции и материалов, планировать и прогнозировать отходы и загрязнение, восстанавливать природные системы. Циркулярная экономика (экономика замкнутого цикла) имеет два ключевых направления: обеспечение экономической эффективности через восстановление стоимости продуктов в конце их использования; обеспечение выполнения экономических,  экологических и социальных требований устойчивого развития за счет снижения негативного воздействия на окружающую среду. Основная задача нашего исследования состоит в проведении анализа европейских практик перехода к циркулярным моделям. Результаты исследования позволяют обосновать вывод о необходимости разработки и принятия на федеральном уровне Концепция перехода к циркулярной экономике в отраслях производства.
РАЗВИТИЕ КАДРОВЫХ ТЕХНОЛОГИЙ НА ГОСУДАРСТВЕННОЙ ГРАЖДАНСКОЙ СЛУЖБЕ В УСЛОВИЯХ ЦИФРОВОЙ ТРАНСФОРМАЦИИ
Authors: И.А. Васильева , В.В. Ильина , П.В. Николаева
Published: November 2024

Цифровая трансформация экономики и государственного управления Российской Федерации – актуальный вызов и амбициозная задача, которая требует привлечения, развития и удержания профессионалов в государственном секторе экономики. При этом в эпоху цифровизации конкурентная борьба за высококвалифицированные кадры обостряется, что наиболее заметно в таких областях, как разработка высокотехнологичных решений, создание цифровых сервисов, управление на основе данных и др. [1] В работе рассмотрены основные методы и современные подходы по реализации кадровой политики на государственной и муниципальной службе.
СОВРЕМЕННЫЕ ПОДХОДЫ К УПРАВЛЕНИЮ АКТИВАМИ И ПАССИВАМИ КОММЕРЧЕСКОГО БАНКА
Authors: О.Н. Кузнецова , А.В. Зверев , Т.С. Боброва
Published: November 2024

В статье рассматриваются возможные ошибки в структуре активов и пассивов коммерческих банков, которые приводят к различным рискам (потери ликвидности, процентным, валютным), а также систематизируются прогрессивные направления в управлении их имуществом и финансовыми ресурсами (на основе метода конверсии фондов и комбинированного метода). Авторы считают, что для анализа структуры активов и пассивов коммерческих банков целесообразно использовать не традиционный бухгалтерский баланс, а укрупненный баланс с детализацией отдельных статей, созданный в целях управленческого учета. Авторы также предлагают ориентироваться на практику управления активами и пассивами успешных системообразующих банковских учреждений (ПАО «Сбербанк», АО «Альфа банк», ПАО Банк «ФК Открытие» и др.). При этом необходимо грамотно формировать стратегию развития банков, в рамках которой будет осуществляться эффективный менеджмент их операций.
ГОСУДАРСТВЕННОЕ ВЛИЯНИЕ НА ДЕПОПУЛЯЦИОННЫЕ ТЕНДЕНЦИИ В РОССИЙСКОЙ ФЕДЕРАЦИИ
Authors: И.В. Макарычева , Г.А. Шишканова
Published: November 2024

Аннотация. Депопуляция населения – это долговременная тенденция снижения численности населения какой-либо территории. Обычно депопуляция случается либо вследствие миграции, либо из-за превышения смертности над рождаемостью. Последняя причина называется естественной убылью населения, либо отрицательным естественным приростом. В Российской Федерации депопуляция связана именно с естественной убылью. Правительство РФ уже давно, начиная с 2007 года объявило демографическую проблему одним из самых серьезных вызовов нашей государственности. В обновлённой «Стратегии национальной безопасности», принятой в 2021 году задача «Сбережения народа России» вообще стоит под номером один. С 2007 года по сей день правительство последовательно проводит стимулирующую политику, направленную на повышение рождаемости и снижение смертности. На основе анализа данных официальной статистики в статье исследуется, как именно правительство стимулирует рождаемость и какие результаты демографической политики мы можем наблюдать.
ПЕРСПЕКТИВЫ РАЗВИТИЯ МИРОВОГО ТУРИЗМА В СОВРЕМЕННЫХ УСЛОВИЯХ
Authors: В.П. Павлюк , С.Н. Медведева , Е.Ю. Савичева
Published: November 2024

В данной статье освещаются вопросы состояния международного туризма на современном этапе развития, оценивается эффективность и конкурентоспособность туристского потенциала стран мира. Цель статьи направлена на исследование состояния мирового туризма и тенденций, а также влияния COVID-19 на экономическую ситуацию в мире. Предпринятая обзорно-аналитическая работа позволила получить важные исследовательские выводы, касающиеся проблем развития и функционирования мирового туризма, поддержки мирового туризма со стороны различных организаций, развитие туризма, как и развитие тех территорий, где осуществляется туристская деятельность, во многом детерминируется конкурентоспособностью субъектов. Полученные результаты имеют не только теоретическую, но и практическую значимость. Так, отдельные направления и инструменты поддержки мирового туризма в современных сложных условиях заслуживают пристального изучения на предмет возможности повышения их конкурентоспособности в условиях пандемии.
ДОПОЛНИТЕЛЬНЫЕ НАЧИСЛЕНИЯ К ЦЕНЕ ФАКТИЧЕСКИ УПЛАЧЕННОЙ ЗА ВВОЗИМЫЕ ТОВАРЫ – МЕТОДОЛОГИЧЕСКИЕ ПРОБЛЕМЫ ВКЛЮЧЕНИЯ В ТАМОЖЕННУЮ СТОИМОСТЬ ТОВАРОВ
Authors: А.А. Артемьев , Е.Ю. Сидорова
Published: November 2024

Предлагаемая статья посвящена методологическим проблемам определения таможенной стоимости товаров в рамках метода «по стоимости сделки с ввозимыми товарами» (далее – по методу 1). Применение метода 1 предусматривает, что таможенная стоимость товаров включает в себя два элемента: цены, фактически уплаченной или подлежащей уплате за ввозимые товары (далее – ЦФУ) и подсистемы начислений дополнительных к ЦФУ. В статье исследованы методологические проблемы отдельных, наиболее значимых видов дополнительных начислений к ЦФУ. Цель. Провести научную разработку комплекса вопросов, связанных с подходами к включению в таможенную стоимость товаров отдельных видов начислений дополнительных к ЦФУ, на примере: - товаров и услуг, прямо или косвенно предоставленных покупателем бесплатно или по сниженной цене для использования в связи с производством и продажей ввозимых товаров для вывоза на таможенную территорию Евразийского экономического союза (далее – ЕАЭС); - лицензионных и иных подобных платежи за использование объектов интеллектуальной собственности (далее - роялти), которые относятся к ввозимым товарам и которые прямо или косвенно произвел или должен произвести покупатель в качестве условия продажи ввозимых товаров для вывоза на таможенную территорию ЕАЭС. Гипотеза исследования. Действующее в России в условиях членства нашей страны в ЕАЭС и Всемирной торговой организации (далее – ВТО), основанное на международных положениях по определению таможенной стоимости товаров, в значительной степени ориентировано на то, что в состав таможенной стоимости как базы для исчисления таможенных пошлин и одной из составляющих налоговой базы по налогу на добавленную стоимость (далее – НДС). Методы, используемые в исследовании - сравнительный анализ, аналогии, графический и компиляции, индукции и дедукции. Методология проведения работы - обоснование актуальности работы, постановка проблемы, исследование международной практики, результаты исследования и выводы. Научный вклад и результаты и выводы по работе: При рассмотрении комплекса экономических аспектов, и основанных на них норм действующего регулирования научно обоснована дискуссионность подходов ВТО в отношении последствий при предоставленных покупателем бесплатно или по сниженной цене товаров и услуг для использования в связи с производством и продажей ввозимых товаров для вывоза на таможенную территорию страны импортирования. Применительно к включению роялти в таможенную стоимость товаров научно-обоснованые подходы, которые предлагают применение при принятии решения о необходимости, либо об отсутствии такой необходимости по включению в таможенную стоимость товаров роялти, которые уплачиваются за использование объектов интеллектуальной собственности, не содержащихся/не инкорпорированных во ввозимых товарах. Практическая значимость работы состоит в разработке методологических решений по включению в таможенную стоимость товаров дополнительных начислений к ЦФУ за ввозимые товары.