Global Improvement Scores Research Articles

Effectiveness and Safety Profile of Urethral Bulking with Bulkamid® for Stress Urinary Incontinence: A French Multi-Center Cohort Study.

Various treatment options are currently available for the management of stress urinary incontinence (SUI). This study was aimed at determining the effectiveness and safety profile of Bulkamid®, and identify predictive factors of clinical success. This retrospective study conducted in two French urogynecology university centers between September 2019 and December 2023 included all patients with urinary incontinence who received Bulkamid®. Among the 320 patients included (median age 58.2years), the median follow-up was 24 months. Urethral hypermobility was found in 93.4% of patients (n = 282) and 92% (n = 275) had a positive cough test. At 1 month, 68.7% of patients (n = 220) achieved clinical success, 25.6% (n = 82) improved, and 5.6% (n = 18) reported failure. At last follow-up, 63.7% of patients (n = 204) were still cured, 21.9% (n = 70) had improved, and 14.4% (n = 46) reported failure. Among the 16 patients with overactive bladder (OAB) 43.7% had a Patient Global Improvement (PGI) score of 1-2 at 1month and 50.0% at last follow-up, with significant difference compared with patients without OAB, 81.0% had a PGI score of 1-2 at 1month and 74.8% at last follow-up (p = 0.0006 and p = 0.04 respectively). Regarding complications, acute urinary retention occurred in 3.1% of patients (n = 10), urinary infections in 2.2% (n = 7), and transient hematuria in 7.2% (n = 23). In multivariate analysis, follow-up time was significantly associated with failure compared with improvement/cure (OR = 1.05, 95%CI 1.02-1.08, p = 0.0002). The present large series of patients reported the effectiveness of Bulkamid® injection, a minimally invasive procedure providing good clinical outcomes at 2years' follow-up.

Comparing the Effectiveness of Platelet-Rich Plasma Alone Versus Combined With Microneedles or Radiofrequency for Neck Wrinkle Treatment.

Neck wrinkles are a prominent characteristic of skin aging, with recent studies indicating that interventions such as platelet-rich plasma (PRP), microneedling (MN), and radiofrequency (RF) can effectively rejuvenate aging skin. This study aims to assess and compare the efficacy of three treatment modalities in addressing neck wrinkles. Fifteen female participants with a neck Lemperle Wrinkle Assessment Scale (WAS) score of 3-4 were enrolled in a randomized clinical trial. The subjects were randomly assigned to three treatment groups: PRP injection, MN + PRP topical PRP application, and RF + PRP injection. They received treatment once a month for three consecutive months, and a clinical outcome evaluation was performed at 1 and 6 months after the final treatment. The WAS scores and global aesthetic improvement score (GAIS) demonstrated notable enhancements 1 month postfinal treatment across all three groups, with a notably greater number of participants experiencing improved outcomes in the RF + PRP group 6 months posttreatment. Specifically, at the 1-month follow-up, the RF + PRP group exhibited a statistically significant enhancement in skin elasticity and collagen, surpassing the improvements observed in the other two groups (p < 0.05). No significant disparities in skin elasticity and collagen were detected in all groups prior to and after 6 months of treatment. Adverse events were mild and transient, such as redness, swelling, bruising, and pain. This study revealed that all the treatments can effectively improve neck wrinkles 1 month after the last treatment. A better therapeutic effect could be observed in the RF + PRP group compared with the other two groups at 6 months after the last treatment.

Evaluation of a Novel Dermal Cooling System for the Treatment of Benign Pigmented Lesions in Asians.

Our study aimed to evaluate the efficacy of this novel dermal cooling system (DCS) in reducing pigmentation in benign pigmented lesions in Asian patients and its potential side effects. It was a prospective open-label single-center study. Asian patients, with the presence of benign pigmented lesions mainly including lentigines, melasma, nevus spilus, ephelides, café au lait, and seborrheic keratosis were recruited for a novel DCS. The DCS provided localized cooling of the epidermal layer below freezing but was less intense than cryotherapy. Each patient received DCS at Week 0 and repeated at 4-week intervals up to 10 sessions. Global aesthetic improvement scores (GAIS) by blinded physicians and subjects were recorded at 2, 6, and 12 months posttreatment follow-up. Eighty-one patients were recruited with a total of 305 sessions performed and 1716 lesion sites treated. At 2-month posttreatment, 76.5% and 58.6% treatment sites showed obvious to marked improvement respectively and the improvement sustained at 6 and 12 months. Only minor adverse events were reported. Erythema and edema were the most commonly anticipated effects immediately after treatment. The pain was minimal. Postinflammatory hyperpigmentation was only reported in 2.2% (38/1716) treated sites. To our knowledge, this study was the first study to demonstrate that this novel DCS was an effective, safe, and well-tolerated treatment for benign pigmented lesions in Asians.

Safety and effectiveness of apremilast in Japanese patients with psoriatic disease: Results of a post-marketing surveillance study.

The safety and efficacy of apremilast in psoriatic disease has been demonstrated in clinical trials, including in Japanese patients. This post-marketing surveillance study was conducted after approval of apremalast in Japan in 2016 to evaluate the safety and effectiveness of the drug in Japanese patients with plaque psoriasis (PsO) and psoriatic arthritis (PsA) in routine clinical practice. Patients (enrolled between September 1, 2017, and August 31, 2019), were observed for 12 months after apremilast treatment initiation or until discontinuation or withdrawal. Safety was assessed by evaluating adverse reactions (ARs) and serious ARs. Effectiveness measures in PsO included the proportion of patients who achieved global improvement and Physician's Global Assessment (PGA) scores of 0/1 and the change from baseline in the Dermatology Life Quality Index (DLQI) after 6 and 12 months treatment. The safety analysis set included 1063 patients (PsO, n = 992; PsA, n = 127). ARs and serious ARs were reported in 29.4% and 0.7% of patients, respectively; most occurred <1 month after apremilast initiation. There were no reports of fatal ARs, serious infections, hypersensitivity, or vasculitis. No new safety signals were identified. Among the key survey items, gastrointestinal disorders were the most common ARs (21.3%). In patients with PsO, after 6 and 12 months of treatment, effectiveness rates of achieving highly effective or effective global improvement of were 90.9% and 93.8%; PGA 0/1 was achieved by 42.7% and 58.1% of patients; mean decrease from baseline in total DLQI score was 4.2 (p < 0.0001) and 5.7 (p < 0.0001), respectively. Effectiveness was evaluated in a small number of patients with PsA for some measures; after 6 and 12 months of treatment, improvements were observed in global improvement effectiveness rates, Disease Activity Score in 28 Joints score, Visual Analog Scale score, and DLQI score. We conclude that orally administered apremilast was well tolerated and effective in Japanese patients with PsO and/or PsA enrolled in this post-marketing surveillance study.

Microneedle fractional radiofrequency associated with drug delivery for facial atrophic acne scars and skin rejuvenation

ABSTRACT Microneedle fractional radiofrequency (MFRF) has been used to improve photoaging and scars. This study aimed to evaluate the efficacy and safety of MFRF with basic fibroblast growth factor (bFGF) for facial atrophic acne scars and skin rejuvenation by blinded visual evaluation, self-report, and reflective confocal microscopy (RCM). Fifteen subjects were randomized to the MFRF with bFGF group and fifteen to the MFRF group. All subjects underwent three-session therapy and a follow-up period. Significant group differences were in ECCA, global improvement score, satisfaction, and downtime before and after treatment. Combination therapy could be more effective than monotherapy for acne scars and facial rejuvenation. In addition, RCM can be used to observe the changes in skin collagen before and after treatment in evaluating cosmetic efficacy.

Oral tranexamic acid treats papulopustular rosacea by improving the skin barrier.

Papulopustular rosacea (PPR) is a chronic inflammatory disease with a significant impact on facial aesthetics. An impaired skin barrier is an important factor in the development and exacerbation of PPR. Tranexamic acid (TXA) has immune regulatory and anti-inflammatory effects, inhibits angiogenesis and endothelial hyperplasia, and promotes skin barrier repair. We investigated the efficacy and safety of oral TXA for PPR treatment. In total, 70 patients were randomly assigned to receive traditional therapy plus oral TXA or traditional therapy alone for 8 weeks, with a 4-week follow-up period. The subjective improvement in rosacea was assessed using the clinical erythema assessment (CEA), investigator's global assessment (IGA), patient self-assessment (PSA) score, rosacea-specific quality of life (RQoL) score, and global aesthetic improvement score (GAIS). An objective improvement in rosacea was assessed using skin hydration, trans-epidermal water loss (TEWL), clinical photography, and an eight spectrum facial imager. CEA/IGA/PSA, dryness, and RQoL scores were significantly lower and GAIS was higher in the TXA group than in the traditional therapy group. Furthermore, oral TXA significantly improved skin barrier function, increased skin hydration, and decreased TEWL, with no significant side effects. Notably, we observed better outcomes and a greater improvement in skin barrier function with TXA treatment in patients with dry-type rosacea than in patients with oily skin. The addition of oral TXA to traditional therapy can lead to rapid and effective improvements in PPR, which may be attributed to improvements in skin barrier function.

Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain, and Ocular Surface Irritation.

To investigate the effect of a compression dressing (CD) on edema, ecchymosis, aesthetic outcome, pain, and ocular surface irritation after upper eyelid blepharoplasty. We conducted a case-control study. Bilateral blepharoplasty was performed on both upper eyelids at the same time in patients with dermatochalasis. One side was randomized for CD. Edema and ecchymosis were scored at a 4-point rating scale by a blinded observer 1 day (D1), 1 week (D7), and 8 weeks (D56) after surgery; the same for scar formation regarding redness and bulging at D7 and D56. Aesthetic outcome was evaluated by the patient and blinded observer using the global aesthetic improvement score at D1, D7, and D56. Postoperative pain was scored by the patients using a visual analogue scale (0 to 10) at D1. At D1 patients had to state which side they felt more comfortable. Edema, scar formation and aesthetic outcome evaluated by the patient and blinded observer did not differ between the 2 sides on any of the survey days ( p > 0.05). The median degree of ecchymosis was slightly higher on the lids without CD at D1 (1 [0-2] vs. 1.5 [0-2]; p = 0.495) and D7 (0 [0-2] vs. 0.5 [0-2]; p = 0.183), but not statistically significant. Postoperative pain was similar regardless to the use of CD ( p = 0.925). The majority (55%) found the side without CD more comfortable. There was no case of corneal erosion and corneal staining was similar in both groups ( p > 0.05). Using a CD after blepharoplasty shows no advantages regarding postoperative edema, ecchymosis, scar formation, or aesthetic results in the early postoperative period. As most patients preferred the noncovered side, CD can be omitted after blepharoplasty without inferiority for the postoperative results. NCT06111170.

Oxcarbazepine for the treatment of bipolar and depressive disorders in the outpatient setting: A retrospective chart review

Oxcarbazepine is often utilized off-label for bipolar and depressive disorders in outpatient settings despite limited evidence. We performed a retrospective chart review on 38 adult outpatients diagnosed with bipolar and depressive disorders (ICD-10 codes F30-39), treated with oxcarbazepine by psychiatrists and psychiatric nurse practitioners between 2015 and 2021. Primary outcomes were Clinical Global Impression Severity (CGI-S) and Improvement (CGI-I) scores, assigned retrospectively from clinical documentation. Patients were predominantly female (70%), aged 20–76 (mean 36), with a mean of 1.8 DSM diagnoses (range 1–4) and 1.7 (range 0–5) concurrent psychotropic medications. A starting mean oxcarbazepine dose of 489 mg/day, titrated to a mean final dose of 663 mg/day, was associated with a CGI-I of 2.5 [2.25, 2.75] and a pre-to-post treatment decrease in CGI-S from 3.4 to 2.4. Overall response and remission rates were 52% and 29%, respectively. Limitations of this study include potential sample bias, documentation bias and rater bias among other limitations inherent to retrospective study designs.

Prospective comparative clinical study: Efficacy evaluation of collagen combined with hyaluronic acid injections for teartrough deformity.

Tear trough filling is a popular facial rejuvenation procedure, and hyaluronic acid is typically used as the filler of choice. However, Tyndall's phenomenon, a common complication following hyaluronic acid injection, can occur, leading to skin discoloration of the lower eyelid. This single-center, prospective, comparative clinical study aimed to evaluate the efficacy of collagen and hyaluronic acid injections in treating tear trough deformity. Sixty patients were enrolled between June 2022 and January 2023. Patients were randomly allocated into three groups: Group A received hyaluronic acid, Group B received hyaluronic acid combined with collagen, and Group C received collagen alone. Baseline characteristics, including age, sex, and tear trough deformity grade were considered before therapy. Changes in tear trough deformity scores, Global Aesthetic Improvement Scores, and the presence of the Tyndall effect were analyzed at 1 and 3 months postinjection to determine differences among the three groups. Baseline profiles of the three groups were similar. In the first month postinjection, there was no difference in the Global Aesthetic Improvement Scores and tear trough deformity between the three groups. However, in the third-month postinjection, there was a significant difference in scores between patients in Group C and those in Groups A or B. The Tyndall effect manifested in three patients in Group A, which was significantly different from that in Groups B and C. The combined use of hyaluronic acid with collagen in injectable fillers corrected tear trough deformities and reduced the occurrence of the Tyndall phenomenon, which can be problematic with hyaluronic acid alone. Additionally, this combination may help overcome the disadvantage of a shorter retention period when using collagen alone.

Remodeling of facial soft tissue induced by simultaneous application of HIFES and synchronized radiofrequency provides nonsurgical lift of facial soft tissues.

The application of radiofrequency (RF) and HIFES on the body provides improvement in skeletal muscle tissue, reduction in fatty tissue, reorganization of connective tissue, and skin texture improvement. However, overall facial appearance relies on both skin and underlying structures, specifically muscles and connective tissue which have to be treated as one unit to achieve proper care while preserving fatty layers that define youth facial appearance. The aim of this study is to find whether the effect of novel RF + HIFES is safe and can induce the lifting of soft tissue and overall improvement in facial appearance. In this study, 21 subjects were enrolled. The therapy was administered in four 20-min treatments on the forehead and cheeks. Photographs were evaluated by a Global Aesthetic Improvement Score (GAIS) and linear measurements of facial tissue lifting at 1- and 3-month follow-ups. Volumetric changes in the cheek area were investigated as well. The patients' satisfaction, safety, and comfort were documented throughout the study. The data indicated improvement in overall facial appearance, and 23% of average lifting was found in brows (p = 3.14 × 10-12 ) and cheeks (p = 6.00 × 10-15 ). The assessment of digital photographs showed an improvement in 100% of patients at 3-month follow-up. The treatments were safe, accompanied by high therapy comfort and subject satisfaction of 98%. The treatment by simultaneous RF and HIFES technology produces significant changes to the overall facial appearance, characterized by the lifting of facial tissues.

Compression Dressing versus Noncompressive Transparent Eye Shield after Ptosis Surgery.

We aimed to investigate the effect of compression dressing on edema, ecchymosis, pain, and ocular surface irritation after ptosis surgery. After ptosis correction [anterior levator reinsertion (and resection) (ALR), if necessary additional blepharoplasty], the eye was randomized for compression dressing or transparent eye shield. Edema and ecchymosis were scored on a four-point rating scale by a blinded observer 1 day (D1), 1 week (D7), and 8 weeks (D56) after surgery; the same was done for scar formation regarding redness and bulging at D7 and D56. Aesthetic outcome was ranked by patient and blinded observer using the Global Aesthetic Improvement Score at D1, D7, and D56. Postoperative pain was scored using a visual analogue scale (0 to 10) at D1. Impairment after surgery by dressing or eye shield was evaluated at D1. Ecchymosis, edema, scar formation, and aesthetic outcome ranked by the patient and blinded observer did not differ between the groups with compression dressing and eye shield at any day of follow-up (P > 0.05). Postoperative pain and impairment were the same in both groups (P > 0.05). One case of corneal erosion occurred in the group with compression dressing at D1 (P = 0.342). At D7, corneal staining was increased in the group without compression dressing (P = 0.930). Compression dressing after ALR does not reduce ecchymosis, edema, or postoperative pain and has no effect on early scar formation or aesthetic results. To prevent corneal erosion caused by the dressing, it can be omitted after ALR without inferiority for the early postoperative results.

Needle-Free Jet Injector-Assisted Triamcinolone Treatment of Keloids and Hypertrophic Scars is Effective and Well Tolerated in Children.

Keloids and hypertrophic scars can cause severe pain, pruritus, and psychological distress. Conventional intralesional corticosteroid treatment with needle injections remains challenging, especially in children with needle phobia. We aimed to evaluate the effectiveness, tolerability, and patient satisfaction of intralesional treatment with triamcinolone acetonide using a needle-free electronic pneumatic jet injector in children with keloids and hypertrophic scars. A retrospective study was performed in children with keloids and hypertrophic scars who received intralesional triamcinolone acetonide treatments using an electronic pneumatic jet injector. Effectiveness was evaluated using the Patient and Observer Scar Assessment Scale and Global Aesthetic Improvement Score at follow-up versus baseline. Tolerability was assessed with reported adverse effects and injection-related pain using a visual analog scale. Satisfaction questionnaires were used to evaluate treatment-related patient satisfaction. Six female patients and five male patients aged 5-17 years, with a total of >118 keloids or hypertrophic scars were included. Electronic pneumatic jet injector treatment led to a significant reduction in the total Patient and Observer Scar Assessment Scale observer and patient scores compared with baseline, with a median reduction of 28.9% and 23.8%, respectively (p = 0.005; p = 0.009). Median visual analog scale pain scores for electronic pneumatic jet injector treatment were significantly lower compared with needle injections, 3.0 versus 7.0, respectively (p = 0.027). No severe adverse effects were reported. Overall, 6 patients were 'satisfied' and five patients were 'very satisfied' with the treatment. Electronic pneumatic jet injector-assisted intralesional triamcinolone acetonide is an effective and well-tolerated treatment for keloids and hypertrophic scars in children. It should be considered as an alternative non-traumatic delivery method, especially in children with needle phobia or severe pain during previous needle injections.

Clinical Trial of Alpha and Beta Defensin Skin Care Regimen for Improvement of Periocular Wrinkles.

Defensins recruit leucine-rich repeat-containing G protein-coupled receptor 6 positive (Lgr6+) stem cells which ultimately regenerate new basal stem cells, healthy keratinocytes, and nascent hair follicles. Thus, defensins are an exciting, novel therapy for the reversal of skin aging. This is a multicenter, prospective, open-label clinical trial. Twenty healthy subjects, aged 45-80, with Fitzpatrick skin types II-IV were enrolled in the study. A skin care regimen containing alpha-defensin 5 and beta-defensin 3 were applied to the face twice daily for 12 weeks. This skin care regimen contains a greater percentage of defensins than that already studied.7 All participants underwent imaging at baseline, day 30, day 60, and day 90. Primary endpoints included investigator scoring on the Fitzpatrick-Goldman wrinkle scale and percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance. Secondary endpoints were investigator Global Aesthetic Improvement Score (GAIS), subject GAIS, and investigator assessment of tolerability. A final subject questionnaire was completed on day 90.&nbsp; Results: Based on the Fitzpatrick-Goldman wrinkle scale, a statistically significant improvement was noted in both wrinkling and elastosis from baseline to day 90. 30% of subjects were rated as much improved and 50% of subjects were rated as improved on the physician GAIS at the 90 day follow up. Improvements were noted in all aspects of skin quality including wrinkles, laxity, dyschromia, erythema, texture, and radiance.&nbsp; Conclusion: The enhanced formula containing increased concentrations of alpha-defensin 5 and beta-defensin 3 is a safe and efficacious topical therapy for the treatment of periorbital rhytids. Hartman N, Loyal J, Taub A, et al. Clinical trial of alpha and beta defensin skin care regimen for improvement of periocular wrinkles. J Drugs Dermatol. 2023;22(9):874-880. doi:10.36849/JDD.7184.

Effects of transcranial pulse stimulation on autism spectrum disorder: a double-blind, randomized, sham-controlled trial.

Transcranial pulse stimulation has been proven effective to improve cognition, memory and depressive symptoms of Alzheimer's disease, but supporting evidence on other neurological diseases or neuropsychiatric disorders remains limited. This study aimed to investigate the effects of transcranial pulse stimulation on the right temporoparietal junction, which is a key node for social cognition for autism spectrum disorder, and to examine the association between transcranial pulse stimulation and executive and social functions. This double-blinded, randomized, sham-controlled trial included 32 participants (27 males), aged 12-17 years with autism spectrum disorder. All eligible participants were randomized into either the verum or sham transcranial pulse stimulation group, on a 1:1 ratio, based on the Childhood Autism Rating Scale screening score. Sixteen participants received six verum transcranial pulse stimulation sessions (energy level: 0.2-0.25 mJ/mm2; pulse frequency: 2.5-4.0 Hz, 800 pulse/session) in 2 weeks on alternate days. The remaining 16 participants received sham transcranial pulse stimulation. The primary outcome measure included Childhood Autism Rating Scale score changes, evaluated by parents, from baseline to 3-month follow-ups. Secondary outcomes included a self-reported questionnaire responded to by parents and cognitive tests responded to by participants. A licensed mental health professional evaluated clinical global impression severity, improvement, efficacy and total score. Results revealed significant interactions in Childhood Autism Rating Scale and other secondary outcomes. Significant group and time effects were found in most secondary outcomes. Additionally, significant differences were found between the transcranial pulse stimulation and sham transcranial pulse stimulation groups in Childhood Autism Rating Scale and clinical global impression improvement and total score immediately after 2 weeks of transcranial pulse stimulation intervention (all P < 0.05), and effects were sustainable at 1- and 3-month follow-up, compared with baseline. The effect size of Childhood Autism Rating Scale (d = 0.83-0.95) and clinical global impression improvement (d = 4.12-4.37) were large to medium immediately after intervention and sustained at 1-month post-stimulation; however, the effects were reduced to small at 3-month post-stimulation (d = 2.31). These findings indicated that transcranial pulse stimulation over right temporoparietal junction was effective to reduce the core symptoms of autism spectrum disorder, as evidenced by a 24% reduction in the total Childhood Autism Rating Scale score in the verum transcranial pulse stimulation group. Additionally, the clinical global impression total score was reduced by 53.7% in the verum transcranial pulse stimulation group at a 3-month follow-up, compared with the baseline. Participants in the verum transcranial pulse stimulation group had shown substantial improvement at 1- and 3-month follow-ups, compared with baseline, although some of the neuropsychological test results were deemed statistically insignificant. Future replication of this study should include a larger sample derived from multi-nations to determine transcranial pulse stimulation as an alternative top-on treatment option in neuropsychiatry.

An Interim 6-Month Analysis of the Dermatologic Effects and Midface Volume Correction With XTR CL Filler in a Prospective, Single-Center Study.

Hyaluronic acid-based filler injections with parenteral anesthetics have become the standard in treating midface volume deficits. There are currently limited data on the effects of these types of fillers on skin density, thickness, and firmness. This study aimed to assess the efficacy of XTR CL filler in improving skin quality and tissue volume in women with midface volume loss. In this prospective, noncomparative, single-center study, 50 women aged between 40 and 60 years with midface volume loss were recruited. The primary endpoint was the improvement in investigator-assessed Global Aesthetic Improvement Scores (GAIS) 1 month after treatment. Secondary endpoints include objective measurements of skin density, thickness, and quality measurements, facial and/or cheek volume augmentation, subjective GAIS, and device evaluation from after the first injection until 6 months, and the documentation of injection site reactions and adverse events. XTR CL use led to significant improvement in midface volume deficits, and skin quality and skin thickness. Injector and subject satisfaction with the treatment were documented and only mild-to-moderate adverse reactions were reported. XTR CL was shown to be effective in improving volume loss and skin quality at 6 months.

Validation of Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score and Other Efficacy Outcomes as Measures of Skin Disease in Dermatomyositis in the Lenabasum Phase 3 Trial

In the past decade, there have been six industry-sponsored phase 3 trials in adult patients with dermatomyositis (DM), primarily focusing on improving muscle weakness. However, skin disease is a cardinal manifestation of DM. This study evaluated the sensitivity of Cutaneous Dermatomyositis Disease Area and Severity Index Activity score, Cutaneous Dermatomyositis Activity Investigator Global Assessment, Total Improvement Score, and other outcome measures used in DM clinical trials to detect improvement in DM skin disease activity. Data analyzed from the lenabasum phase 3 trial in DM showed that improvement in Cutaneous Dermatomyositis Disease Area and Severity Index Activity score increased proportionately with the degree of patient- or physician-reported improvement in skin disease, consistently measuring improvement when clinically meaningful improvement was reported at weeks 16-52. In contrast, Cutaneous Dermatomyositis Activity Investigator Global Assessment measured little change from baseline with reported no improvement in skin disease but also a similar change from baseline with slight improvement. No Skindex-29+3 subscale performed well at reflecting increasing degrees of improvement in skin disease. Extramuscular Global Assessment and Total Improvement Score generally showed increasing levels of improvement as the degree of patient- and physician-reported improvement in skin disease increased, but these are composite measures and are not specific to improvement in DM skin disease. To measure clinically meaningful improvement in skin disease in a DM trial, Cutaneous Dermatomyositis Disease Area and Severity Index Activity score is the more sensitive outcome measure across time points.

Do older adults respond to cognitive behavioral therapy aswell as younger adults? An analysis of a large, multi-diagnostic, real-world sample.

Older adults (OA; ≥55years of age) are underrepresented in patients receiving cognitive-behavioral therapy (CBT). This study evaluates mental health outcomes for OA compared to younger adults (YA; <55years of age) receiving CBT. This is a pre-post study comparing the effectiveness of CBT for OA (n=99) and YA (n=601) in a CBT service located in a university-affiliated tertiary care hospital in Canada. Data was collected between 2001 and 2021. Participants received a mean of 18.5 sessions (SD 10) of standard, evidence-based CBT with treatment integrity checks. The main outcome was clinically significant change, as measured by the Reliable Change Index (RCI). Secondary outcomes were change in the Global Severity Index (GSI-SCL) of the Symptoms Checklist-90 (Revised), and Clinical Global Improvement scores (CGI). The RCI allowed a comparison of treatment efficacy across diagnoses. Both groups experienced similar improvement on the RCI (2.92 [±3.64] vs. 3.15 [±4.86], p=0.65). Furthermore, 39% of OA and 42% of YA no longer met criteria for their diagnoses. Groups did not differ with respect to changes in the GSI-SCL. The CGI severity comparison suggested that OA had milder illness. In all outcomes (RCI, CGI and GSI-SCL), participants improved over time. This real-world study analyzed a large sample of OA and YA undergoing CBT for various mental health conditions. Both groups were found to benefit equally.

Outcome of transcranial magnetic intermittent theta-burst stimulation in the treatment of depression - A Swedish register-based study

BackgroundRepetitive transcranial magnetic stimulation (rTMS) is an established treatment of depression. The more recently introduced intermittent Theta-burst stimulation (iTBS) has shown significant superiority over sham-stimulation and equal effect sizes to a 10 Hz protocol in one clinical trial. The aim of the current study was to investigate the effectiveness and tolerability of iTBS in a naturalistic, clinical setting. Further, we explored demographical and clinical predictors of response. MethodsData was collected from seventeen rTMS-sites in Sweden between January 2018 and May 2021, through the Swedish National Quality register for repetitive Transcranial Magnetic Stimulation (Q-rTMS). We included 542 iTBS-treated patients with unipolar or bipolar depression. Outcome was assessed with Clinical Global Impression Severity and Improvement scores in an intention to treat analysis. ResultsThe response rate was 42.1 % and 16.1 % reached remission. The response rate was significantly larger in the oldest age group compared to the youngest (odds ratio 3.46, 95 % confidence interval 1.65–7.22). Less severe level of depression (Montgomery-Åsberg depression rating scale self-assessment < 36) at baseline predicted response and remission. Only <1 % were much or very much worse after treatment. Drop-out rate was 10.9 %. No serious adverse events were reported. LimitationsRetrospective analysis of register data. No comparison group. ConclusionsIn a clinical setting, iTBS was shown to be safe and tolerable and the response rate was similar to that reported from clinical trials. Older age-group and less severe illness predicted response.

EFFECTIVENESS OF LASER CARBON PEEL FOR FACIAL REJUVENATION.

Background: The laser carbon peel is a fast and painless procedure done to help improve the look of skin mainly for people with oily skin, acne, and enlarged or clogged pores. As the awareness of people regarding cosmetic dermatology is increasing, there is a growing desire to look near awless so this study is taken up to assess the effectiveness of facial rejuvenation in our set of patients. A total of 30 people Materials &amp; Methods: were enrolled in the study after informed consent. Carbon peel was applied evenly and let dry. Q switched Nd YAG laser (1064 nm) was done at the energy of 2000 mJ and 9Hz. A total of 3 sessions were done 3 weeks apart. Pre and post-photographs were taken at every visit and results were compared. Results were assessed by Global Aesthetic Improvement Score (GAIS) and through a patient satisfaction questionnaire. In 30 Results: patients who were included in the study, the main indication was PIH and pigmentation in 16 (53.3%) of the total population. Among 30 patients, 20% had very much improvement, 13.3% had much improvement, 46.6% improvement, and 20% had no change according to GAIS. There was a signicant improvement even in individual variables. No adverse events were reported. Carbon laser peel was found to be an effective Conclusion: treatment modality for patients desiring facial rejuvenation with an excellent safety prole and the least downtime.

Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results.

IntroductionWe report an exploratory analysis of the efficacy and safety of certolizumab pegol (CZP) in Japanese patients with generalized pustular psoriasis (GPP) and erythrodermic psoriasis (EP) (NCT03051217).MethodsPatients ≥ 20 years with GPP or EP were randomized 1:1 to open-label CZP 400 mg every 2 weeks (Q2W) or 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks; patients who achieved “much improved” or “very much improved” on the Global Improvement Score (GIS; for GPP) or a PASI 50 response (≥ 50% reduction from baseline Psoriasis Area and Severity Index; for EP) continued to week 52. Efficacy outcomes assessed included Clinical Global Impression of Improvement (CGI-I), Dermatology Life Quality Index (DLQI 0/1), and Itch Numeric Rating Scale (INRS 0). GIS and Japanese Dermatological Association (JDA) severity index were assessed in patients with GPP, and PASI and Physician’s Global Assessment (PGA) in patients with EP. Treatment-emergent adverse events (TEAEs) were evaluated through weeks 0–52.ResultsOf 22 patients randomized, 19 completed week 52. At week 16, all reported outcomes improved with both CZP doses and were generally maintained through week 52. At week 52, 6/7 GPP and 12/12 EP patients achieved CGI-I response (“improved” or “remission”). Also, 4/7 GPP and 7/12 EP patients achieved DLQI 0/1; 2/7 GPP and 2/12 EP patients achieved INRS 0. Meanwhile, 6/7 patients with GPP achieved GIS response, and JDA severity index was reduced from baseline. We found that 9/12 and 5/12 patients with EP achieved PASI 90 and PGA 0/1, respectively. Overall, three serious TEAEs were reported in three CZP 400 mg Q2W-treated patients.ConclusionCZP treatment over 16 weeks improved the signs and symptoms of GPP and EP, and improvements were maintained through week 52. No new safety signals were identified.Trial RegistrationClinicalTrials.gov identifier, NCT03051217.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-022-00741-x.