INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study.

BACKGROUND: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients’ functioning and activities of daily living (ADL) are needed. METHODS: A 12-week, single-arm, prospective cohort study was conducted in patients ≥9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (>12 years) and caregivers (for patients 9-11 years). Additional assessments included parental/caregiver perspectives on children’s AV. RESULTS: A total of 253 patients completed the study. Following 12-weeks of treatment, there were significant (P ≤.0001) changes from baseline in the proportion of patients responding that they never or rarely: felt angry (31.6%), worried about AV worsening (28.9%), had thoughts about AV (20.9%), had a certain level of worries about AV (38.7%), altered their social media/selfie activity (23.7%), had an impact on real-life plans due to AV (22.9%), made efforts to hide AV (21.3%), felt picked-on/judged due to AV (15.0%), were concerned about their ability to reach future goals due to AV (13.8%), or had sleep impacted due to AV (18.2%). No significant change from baseline was observed for parent/caregiver’s understanding of the child’s AV concerns, from both patient and parent/caregiver perspectives. CONCLUSIONS: Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice. J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11.

INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study.

BACKGROUND: Patient-reported outcomes (PROs) are emerging as a fundamental component of disease impact assessment in acne vulgaris (AV), complementing clinician-reported outcomes. No data is available on PROs for patients with AV using sarecycline in real-world settings. METHODS: A single-arm, prospective cohort study that included patients ≥9 years old diagnosed with moderate or severe non-nodular AV was implemented as part of routine care in clinical practices (N=30). Patients received oral sarecycline (60 mg, 100 mg, or 150 mg) for 12 weeks, as part of usual care. The primary endpoint was Acne Symptom and Impact Scale (ASIS) responses from patients (≥12 years) and caregivers (for patients 9-11 years) at week 12 and change from baseline (CFB). Investigator’s Global Assessment (IGA) of AV severity and adverse events (AEs) were also recorded. RESULTS: A total of 253 patients with AV completed the study (adults: 60.1%, females: 77.6%). ASIS mean scores significantly decreased (P <.0001) at week 12 for: signs (mean CFB ± standard deviation [SD]: –0.8 ± 0.7), impact (–1.0 ± 1.0), emotional impact (–1.2 ± 1.1), and social impact (0.6 ± 1.1). Significant reductions in AV severity (P <.0001) were reported by patients and caregivers. The IGA success rate was 58.9% and physician satisfaction with treatment outcomes was 88.1%. A total of 31 (10.3%) patients reported ≥1 AE during the study. CONCLUSIONS: Patients with moderate-to-severe AV receiving acne management with an oral antibiotic for 12 weeks experienced a significant improvement in AV-related symptoms and psychosocial burden. J Drugs Dermatol. 2024;23:1(Suppl 1):s12-18.

Mechanism of Action of Brodalumab May Correlate With Efficacy in Patients With Inflammatory Skin Diseases.

Biologic therapy is used for systemic treatment of multiple inflammatory conditions, including moderate-to-severe plaque psoriasis. Brodalumab is an interleukin-17 (IL-17) receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. The unique mechanism of action of brodalumab, which blocks signaling mediated by multiple IL-17 family members, may play a key role in the overall efficacy, including in patients whose disease did not respond to other biologics. In this narrative review, we discuss the mechanism of action of brodalumab in inflammatory skin conditions, exploring how it relates to clinical and real-world efficacy, rescued responses after IL-17A inhibitor failure, and improvements in mental health and quality of life. J Drugs Dermatol. 2023;22(10):994-1000 doi:10.36849/JDD.7701.

"Pick" wisely: An approach to diagnosis and management of pathologic skin picking.

Manipulation of the skin is ubiquitous in most individuals along a spectrum of extent and severity. Skin picking that results in clinically evident changes or scarring to the skin, hair, and nails or significantly impairs intrapsychic, psychosocial, or occupational function is considered pathological picking. Several psychiatric conditions are associated with skin picking, including obsessive-compulsive disorder, body-focused repetitive behaviors, borderline personality disorder, and depressive disorder. It is also associated with pruritus and other dysesthetic disorders. Although pathologic skin picking, also known as excoriation disorder, is a distinct diagnosis in the Diagnostic and Statistical Manual of Mental Disorders (DSM5), this review attempts to further classify the diagnosis into the following 11 picker categories: organic/dysesthetic, obsessive-compulsive, functionally autonomous/habit, anxious/depressed, attention deficit hyperactivity disorder, borderline, narcissistic, body dysmorphic, delusional, guilty, and angry picker. An organized conceptualization of skin picking can guide providers toward a constructive management approach, ultimately increasing the likelihood of successful therapeutic outcomes.

Evaluation and management of the dysesthetic patient.

Dysesthesia is symptomatology that includes but is not limited to sensations of pain, burning, crawling, biting, numbness, piercing, pulling, cold, shock-like, pulling, wetness, and heat. These sensations can cause significant emotional distress and functional impairment in affected individuals. Although some cases of dysesthesia are secondary to organic etiologies, most cases exist without an identifiable infectious, inflammatory, autoimmune, metabolic, or neoplastic process. Ongoing vigilance is required for concurrent or evolving processes, including paraneoplastic presentations. Elusive etiologies, unclear treatment regimens, and stigma leave patients and clinicians with a difficult path forward marked by "doctor shopping," lack of treatment, and significant psychosocial distress. We address this symptomatology and the psychosocial burden that often comes with it. Although notoriously labeled as "difficult to treat," dysesthesia patients can be effectively managed, making life-changing relief possible for patients.

Onset of Plaque Psoriasis Treatment Responses With Anti-IL-17/IL-23 Biologic Therapies.

BACKGROUND: The impact of psoriasis on quality of life arises from both physical symptoms, such as pain and pruritus, and the psychosocial effects of the often highly visible lesions. For patients with moderate-to-severe psoriasis seeking amelioration of these symptoms, time to onset of treatment response is an important consideration when determining an appropriate therapeutic approach with their healthcare provider. METHODS: In this review, we discuss the fluidity of the definition of rapid response and time-to-response expectations of patients with psoriasis receiving biologic therapies. Next, we focus on time to response of brodalumab, a human anti–interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe psoriasis, as measured by the psoriasis area and severity index and the psoriasis symptom inventory. Brodalumab previously exhibited efficacy and safety in treatment of moderate-to-severe psoriasis in three phase 3 trials (AMAGINE-1/-2/-3), warranting further characterization of its ability to meet patient needs regarding rapidity of treatment response. Finally, we place time to response of brodalumab in the context of the current treatment landscape of biologic therapies for psoriasis (particularly those targeting the interleukin-17/interleukin-23 axis). RESULTS: Direct and indirect comparisons with other interleukin-targeting drugs support brodalumab’s more rapid onset of treatment effects, including skin clearance and relief of itch and pain. CONCLUSION: Brodalumab induces a rapid treatment response in patients with moderate-to-severe psoriasis and may promote earlier improvements in quality of life. J Drugs Dermatol. 2022;21(8):854-860. doi:10.36849/JDD.6791.

The Use of Brodalumab in Three Patients with Psoriasis and Psychiatric Comorbidities.

Brodalumab, a first-in-class interleukin-17 (IL-17) receptor blocker, carries a black box warning for suicidal ideation and behavior, yet it is also one of the most powerful biologic agents in our armamentarium. We wish to highlight three patients with moderate-to-severe psoriasis and comorbid depression who were successfully treated with brodalumab. The patients were chosen by an expert panel comprising dermatologists, psychiatrists, and psychologists. Psoriasis disease severity was measured using the Psoriasis Area and Severity Index (PASI) score. All three patients experienced PASI 100 after treatment with brodalumab (N=3). Importantly, depressive symptoms improved or resolved in two out of three patients. One patient, who had a history of psychiatric hospitalizations, required in-patient psychiatric treatment during treatment. The use of brodalumab in patients with psoriasis can provide rapid-onset improvement in both skin and depressive symptoms.

Psoriasis: Psychosomatic, somatopsychic, or both?

Psoriasis is a chronic inflammatory disorder characterized by substantial psychiatric comorbidity. Historically, anecdotal observations have suggested that psychosocial distress can trigger flares of psoriasis, but over the past several decades, high-quality data from experimental studies support the assertion that stress plays a critical role in the pathogenesis of psoriasis. There may be a subset of patients unable to elicit an appropriate immunosuppressive response to stress through upregulation of cortisol, with resultant exacerbation of their psoriasis. Other notable studies revealed that key neuromodulators, including substance P, calcitonin gene-related peptide, vasoactive intestinal peptide, and nerve growth factor may be potent regulators of neurogenic inflammation that induce psoriasis flares through a stress-mediated mechanism. Preliminary trials in humans that examine psychosocial interventions to reduce stress, as well as animal studies targeting specific neuropeptides, provide support for the concept that alteration of pathways mediated by the stress response represents novel forms of therapy in the management of psoriasis.

Patient-perceived Emotional and Functional Benefits of Poly-L-Lactic Acid (PLLA) for the Treatment of Facial Volume Loss.

Background: Facial volume loss can substantially impact self-perception of the affected individual and his to her social/professional interactions and opportunities. Persons who are perceived as more youthful and attractive are rated as nicer, more energetic, healthier, and more likely to be productive than those perceived to be older and unattractive. Objective: The goal of this study was to assess the changes in emotional and functional status of subjects treated with 2 to 4 monthly PLLA injections to the upper, mid, and lower face. Methods: Fifty subjects were recruited from two community dermatology centers in the United States (Bucks County, Pennsylvania, and Spokane, Washington). Two patient self-report measures were used-The Facial Volume Restoration Outcome Questionnaire and the Rosenberg Self Esteem Scale. Results: Approximately 30 percent of the subjects who completed pre- and post-injection instruments reported increased confidence, increased sense of control, more comfort with others, increased happiness when looking in the mirror, more happiness when their faces were touched, healthier eating, increased contentment, beliefs that they were seen as less stressed by others, increased happiness with their bodies, exercising more, and that their lives were better. Additionally, 43 percent felt more optimistic and 33 percent felt less anxious. The changes in self-esteem, which was self-reported on the Rosenberg scale, were very modest but also favorable. Investigator's Global Assessment (IGA) of facial volume loss improved from 2.2 at baseline to 1.2 at six-month follow-up assessment. Conclusion: Treatment of facial volume loss with PLLA was associated with improvements in patient-perceived emotional and functional status at six months after initial injection.

Skin excoriations: picking apart the picker.

Management of patients who pick at their skin can be challenging. Etiologies and maintaining factors of skin picking are often unclear. Significant psychiatric overlay is often present, and the clinician is left with an overwhelming differential diagnosis and poorly focused management plans which can result in suboptimal clinical outcomes. The purpose of this article is to provide a conceptual framework for the evaluation and treatment of a patient presenting with excoriations. Ten diagnostic categories of pickers are described, and specific suggestions for treatment are offered.

Nonpharmacologic management of psychodermatologic conditions.

Nonpharmacologic management of psychodermatologic conditions includes both structured and unstructured interventions that may ameliorate skin disorders, reduce psychological distress, and improve the functional status of the affected individual. Nonpharmacologic techniques are often referred to as psychocutaneous interventions. This article will review the data on psychocutaneous conditions that have been shown to improve with nonpharmacologic interventions. Suggested clinical approaches to facilitate the implementation of these modalities will be discussed.

Digital videography assessment of patients' experiences using adapalene-benzoyl peroxide gel in the treatment of acne vulgaris.

BACKGROUND: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized. OBJECTIVE: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris. METHODS: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted. Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented. RESULTS: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported. LIMITATIONS: This was an open-label study of 12 weeks duration. CONCLUSION: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.

Filler cheeks: a bright idea? The "eyes" have it.

The evolving field of facial volume restoration is changing our concept of facial rejuvenation. The older concept that "tighter is better" has been largely supplanted by a philosophy recognizing the importance of volume distribution as a defining characteristic of a more youthful face. It is well recognized that restoration of volume in the upper face can lessen or reverse the bottom-heavy, deflated appearance of the aging face. Perhaps of equal or greater importance is the change in light-reflectance patterns that illuminate the upper cheeks and the eyes. The resultant brighter and "perkier" cheeks can change the objective appearance and the patient's self perception of youthfulness. In this commentary, the author describes techniques to enhance outcomes and patient satisfaction and presents the results of a patient self-report pilot study assessing patient post-injection mood state and functioning.

Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.

Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris. The primary efficacy endpoint was the change from baseline in total acne lesions; the primary safety endpoint was the change in cutaneous irritation scores. The 247 participants (mean age: 18.5 years) were randomized to either the morning/morning regimen (n = 123) or the morning/evening regimen (n = 124). The morning/morning regimen was determined to be non-inferior to the morning/evening regimen in reduction of total acne lesions. The tolerability of both regimens was comparable. The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris.

Acne epidemiology and pathophysiology.

The demographic profile of facial acne vulgaris has changed during the past several decades; 12 years of age is no longer the low end of the "normal" range for onset of acne. The available epidemiologic evidence raises more questions than it answers regarding the etiology of this downward shift. More study is needed to clarify whether the trend toward an earlier onset of puberty in the United States has influenced the clinical picture of acne. Additional research will help advance understanding of the spectrum of pathophysiologic changes in acne in younger pediatric patients and whether it varies from that found in individuals in whom the onset of acne occurs at approximately 12 years of age or later.

Medical and psychosocial impact of acne.

The direct and clinically obvious medical sequelae of acne vulgaris are well described. Physical comorbidities associated with classic acne are quite rare. Often more difficult to detect and measure are the short- and long-term psychosocial consequences of acne. These frequently are devastating and life-altering and in some cases are life-threatening.

Perspectives on therapeutic options for acne: an update.

It is clear that acne vulgaris often has medical and psychosocial implications that can range from mild to severe. To minimize these risks, evaluation and appropriate treatment are necessary, even in the younger pediatric patient. This article provides an overview of the current information on the topical and systemic treatment of acne, including innovative delivery options and new formulations and combinations of existing medications.

Psychosocial sequelae related to acne: looking beyond the physical.

The emotional impact of acne is influenced by numerous factors including age, psychosocial factors, severity of disease, social and familial networks and patient specific personalities. Adolescents are an emotionally vulnerable population, and acne can significantly burden their psychological resources. Looking beyond the physical manifestations of acne can add valuable clinical information aiding clinicians in choosing the most beneficial treatment regimens. Patients at high risk for psychological and/or physical harm can in need of psychiatric referral can also be better recognized.