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.

Ensuring Dermatologists Practice Enhanced Antibiotic Stewardship With Sarecycline Mnemonic.

It must be ensured that dermatologists practice enhanced antibiotic stewardship to combat antimicrobial resistance and negative consequences of microbiome dysbiosis. In order to help achieve this, we have developed a mnemonic ENLIGHTEN to help healthcare providers and patients understand sarecycline’s features.J Drugs Dermatol. 2023;22(10):1061 doi:10.36849/JDD.7437R1.

A Prospective, Multicenter, Study of Laser-Activated Gold Microparticles for Treating Patients Using Concomitant Topical Retinoids for Mild-to-Moderate Inflammatory Acne.

Gold microparticles are indicated as an accessory to 1064 nm lasers to facilitate photo-thermal heating of sebaceous glands for treating mild-to-moderate inflammatory acne vulgaris (Sebacia Microparticles, Coronado Aesthetics LLC, Southlake, TX). The following study assessed the safety and clinical benefit of gold microparticles/laser therapy when used together with commercially available topical acne products. Healthy patients, 12 to 45 years old with mild-to-moderate inflammatory facial acne were prescribed a topical pre-treatment retinoid for 3 to 4 weeks. The gold microparticle suspension was then applied to the entire face and massaged into the skin. The laser procedure was performed with commercially available 1064 nm Nd:YAG lasers with fluence in the 20 to 35 J/cm2 range, a 30 ms pulse duration, and direct cooling. Among participants completing the study (N=52), the mean percent change in inflammatory lesion counts (ILC) was -55% at month 2, reaching -68% at month 12. At that time, 86% of participants achieved a 40% decrease in ILC and 75% achieved a 60% decrease in ILC. Mean Investigator's Global Assessment (IGA) Scale scores decreased by 41.6% from 2.4 at day 0 to 1.4 at month 12. The percentage of participants with clear or almost clear skin increased from 7% at day 0 to 59% at month 12. Acne therapy with topically applied gold microparticles followed by 1064 nm laser irradiation is an effective treatment for moderate to moderately severe acne. The treatment was well-tolerated with a high degree of participant satisfaction. J Drugs Dermatol. 2023;22(11):1088-1094     doi:10.36849/JDD.7744.

Sarecycline treatment for acne vulgaris: Rationale for weight-based dosing and limited impact of food intake on clinical efficacy.

Tetracycline-class antibiotics are frequently prescribed by dermatologists, commonly for acne vulgaris. Gastrointestinal absorption of first and second-generation tetracycline-class antibiotics, including doxycycline and minocycline, may be reduced by co-administration with food, resulting in potentially lower clinical efficacy. Development of novel compounds and formulations that are not impacted by diet could improve compliance, absorption, and effectiveness among patients. The objective of this study is to investigate weight-based dosing protocols and the impact of food intake, including high-fat meals, on the absorption, and clinical efficacy of sarecycline, a novel oral narrow-spectrum third-generation tetracycline-class antibiotic approved by the Food and Drug Administration for acne vulgaris treatment. Data from 12 clinical studies were analyzed using population pharmacokinetic modeling, exposure-response modeling and pharmacodynamics to evaluate sarecycline dosing recommendations. The extent of exposure is estimated to decrease by 21.7% following co-administration of a sarecycline tablet with a high-fat meal. Based on the PopPK-PD model, this is equivalent to a decrease in efficacy of 0.9 inflammatory lesions, which is not clinically meaningful. Sarecycline can be administered using weight-based dosing with or without food. Co-administration with high-fat food has a limited impact on clinical efficacy. The pharmacokinetics of oral sarecycline may provide added convenience and support ease of use and improved compliance for acne vulgaris patients.

Supplement Article: The Role of Epidermal Barrier Dysfunction and Cutaneous Microbiome Dysbiosis in the Pathogenesis and Management of Acne Vulgaris and Rosacea.

BACKGROUND: Dysregulation of either the cutaneous microbiome (CM) or epidermal barrier function (EBF) is thought to play an increasingly important role in acne vulgaris (AV) and rosacea pathogenesis. OBJECTIVE: To review the literature regarding epidermal barrier dysfunction (EBD) and cutaneous dysbiosis in AV and rosacea and provide clinical pearls for dermatologists. METHODS: A Medline literature search was performed for relevant literature regarding EBD and dysbiosis and either AV or rosacea. An expert consensus panel was then convened to discuss article merits and distill findings into clinical pearls. RESULTS: Final review included 138 articles. Puberty may alter natural stratum corneum lipid ratios, instigating and/or exacerbating EBD in AV. Patients with severe AV have an abundance of virulent Cutibacterium acnes phylotype IA1. EBD may manifest as classic signs of rosacea and improve with treatment. While several microbial populations are dysregulated in rosacea, the effect from any singular species is unclear. Current AV and rosacea treatment regimens may mitigate inflammation but may also indiscriminately damage CM and EBF. Physiologic moisturizers and cleansers that harness pre-/pro-/postbiotics may have a role in restoring CM, EBF, and potentially improving dermatosis severity. LIMITATIONS: Limited prospective clinical trial data especially regarding over-the-counter (OTC)/non-prescription skincare products. CONCLUSION: Appropriately developed prescription and OTC preparations may selectively influence the microbiome and potentially maintain/restore EBF. By understanding this relationship, dermatologists will be better able to educate patients on the importance of appropriate skin care.J Drugs Dermatol. 2022;21:9(Suppl 2):s5-14.

Successful Treatment of Periorificial Dermatitis With Novel Narrow Spectrum Sarecycline.

Broad spectrum tetracyclines are a well-known, widely used, and often successful treatment for use in inflammatory skin pathologies such as acne and rosacea. However, the steady rise of antibiotic resistance and gut dysbiosis associated with broad spectrum tetracyclines emphasizes the importance and responsibility of antibiotic stewardship. Narrow spectrum antibiotics have become increasingly important therapies to slow the progression of resistance as well as decrease negative side effect profiles, particularly those associated with broad spectrum tetracyclines. This case shows the successful treatment of periorificial dermatitis with a novel, narrow spectrum tetracycline, sarecycline, in a patient with underlying Crohn’s. J Drugs Dermatol. 2021;20(1):98-100. doi:10.36849/JDD.5678.

Management of Truncal Acne With Oral Sarecycline: Pooled Results from Two Phase-3 Clinical Trials.

BACKGROUND: Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris. METHOD: Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12. RESULTS: Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne. J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204.

The Role of Medical Nutrition Therapy in Dermatology and Skin Aesthetics: A Review

The field of nutritional sciences has advanced beyond research of the role of individual nutrients, supplements, and diet in disease to the multi-disciplinary practice of adjuvant medical nutrition therapy (MNT). Nutrition research is often that of association rather than cause and effect, yet there are compellingly strong relationships between diet and disease severity and incidence of a number of dermatological conditions. MNT is a tailored, evidence-based, comprehensive nutrition intervention strategy delivered by a physician and registered dietitian to a subset of dermatology patients who may benefit from nutrition intervention. With shorter clinical interaction times and patients requesting nutrition information, a collaborative approach may spur clinically meaningful nutritional changes with advice beyond the often quoted "eat better, lose weight, and exercise." This review provides a comprehensive overview of the latest Dermatology Medical Nutrition Therapy (D-MNT) recommendations and advocates an evidence-based, collaborative approach to dermatological patient care. J Drugs Dermatol. 2020;19(1):12-18. doi:10.36849/JDD.2020.4745

Evidence for Anti-Aging South Korean Cosmeceuticals.

As the market for South Korean skin care products grows in the U.S. and worldwide, consumers will increasingly seek advice from dermatologists regarding their efficacy. In this paper, the evidence behind the anti-aging and skin whitening activity of ingredients in the most popular South Korean skin care products was reviewed and critically evaluated. Industry profit data from Euromonitor was obtained to identify the top cosmeceutical brands by retail value in South Korea. The top selling products and their ingredients were then identified from individual brand websites. A comprehensive literature search was conducted using Pubmed to identify and grade the anti-aging and whitening efficacy for nine popular ingredients: licorice, niacinamide, beta-glucan, snail mucus, ginkgo biloba, ginseng, green tea, pomegranate, and soy. Of the various ingredients reviewed, niacinamide, green tea, licorice, and soy have the most published data for anti-aging and whitening activity. Although the literature shows modest results, small sample sizes limit interpretation. High-level evidence to support the use of South Korean skin care products in anti-aging and skin whitening is lacking.

J Drugs Dermatol. 2017;16(4):358-364.

Guidelines of care for the management of acne vulgaris.

Acne is one of the most common disorders treated by dermatologists and other health care providers. While it most often affects adolescents, it is not uncommon in adults and can also be seen in children. This evidence-based guideline addresses important clinical questions that arise in its management. Issues from grading of acne to the topical and systemic management of the disease are reviewed. Suggestions on use are provided based on available evidence.

A review of hand-held, home-use cosmetic laser and light devices.

BACKGROUND: As the market for home-use light-based and laser-based devices grows, consumers will increasingly seek advice from dermatologists regarding their safety and efficacy profiles. OBJECTIVE: To review the literature on home-use hand-held devices for various dermatologic conditions. To educate dermatologists about commercially available products their patients may be using. MATERIALS AND METHODS: A comprehensive literature search was conducted to determine the safety and efficacy of home-use laser and light devices for the treatment of the following: hair removal, acne, photoaging, scars, psoriasis, and hair regrowth. In addition, a thorough search of the Food and Drug Administration's (FDA) radiation-emitting electronic products' database was performed; by searching specific product codes, all hand-held devices that are FDA-approved for marketing in the United States were identified. RESULTS: Of the various home-use devices reviewed, intense pulsed light (IPL) for hair removal and light-emitting diode (LED) for treatment of acne have the most published data. Although the literature shows modest results for home-use IPL and LED, small sample sizes and short follow-up periods limit interpretation. CONCLUSION: There is a paucity of randomized, double-blind controlled trials to support the use of home-use laser and light devices; smaller, uncontrolled industry-sponsored single-center studies suggest that some of these devices may have modest results.

Epithelioid sarcoma resembling benign fibrous histiocytoma.

Epithelioid sarcoma (ES) is a rare malignancy notorious for its tendency to histologically mimic granuloma annulare and other palisading granulomatous processes. We report a case of ES on the right hand of a 23-year-old man that histopathologically resembled a benign fibrous histiocytoma. Superficial portions of the tumor were well differentiated, exhibiting spindled and ovoid cells with scant cytoplasm that surrounded sclerotic collagen bundles. More obvious atypia including greater cellularity, nuclear pleomorphism, and mitotic activity were mostly confined to the deep-seated regions of the tumor. In addition to palisading granulomatous processes, ES can mimic benign fibrous histiocytoma, and the superficial portions of ES may appear deceptively benign.

Collagenase followed by compression for the treatment of earlobe keloids.

BACKGROUND: Many therapeutic options are available for treating keloids, but success rates vary widely, and the keloids often recur. The Food and Drug Administration has recently approved intralesional collagenase for the treatment of Dupuytren's contracture. This medication has not been explored for the treatment of earlobe keloids, a common problem. OBJECTIVE: To evaluate the safety and clinical efficacy of intralesional collagenase followed by compression for the treatment of earlobe keloids. MATERIALS AND METHODS: Six earlobe keloids in six patients were injected with a commercial collagenase preparation. Study participants were asked to use compression earrings daily thereafter. Patients were examined and photographed 1 day, 2 weeks, 4 weeks, 10 months, and 12 months after injection. Adverse events were assessed at each visit, and the keloids were measured and photographed. RESULTS: All patients had a decrease in the size of their earlobe keloid by an average of 50% (p = .02). Three of the six participants chose to have their earlobe keloids surgically excised for cosmetic reasons 6, 8, and 11 months after enrollment, so measurements for data analysis for these patients were taken after only 1, 1 and 10 months. All participants returned for follow-up at the last study visit 1 year after study commencement. The three patients who completed the study were pleased with the improvement of their earlobe keloid, although complete clearance was not achieved. Side effects included injection site swelling, tenderness, and one ulceration that spontaneously resolved within 2 weeks. CONCLUSION: Intralesional collagenase followed by compression appears to be a safe and modestly effective treatment for earlobe keloids. This approach warrants further investigation in larger studies with longer follow-up in motivated patients who decline surgical excision.

A Retrospective Review of a Cohort of Patients with Periorificial Dermatitis Treated with Sarecycline.

Introduction: Periorificial dermatitis (POD) is a common, chronic, inflammatory facial skin rash that presents as tiny papules and papulopustules with underlying eczematous-like patches, typically confined to the perioral, perinasal, and periorbital areas. There is currently no Food and Drug Administration (FDA)-indicated treatment for POD; however, broad-spectrum antibiotics are efficacious as a treatment option. Broad-spectrum antibiotics negatively impact gut flora and lead to antibiotic resistance. Narrow-spectrum tetracyclines, such as sarecycline, have a low potential for promoting bacterial resistance and gastrointestinal issues. Objective: We conducted a retrospective chart review in order to evaluate the efficacy of sarecycline in a cohort of patients diagnosed with POD that were treated with sarecycline. Methods: A review of medical records was completed using an electronic medical record. Inclusion criteria included males and females aged 18 to 95 with a diagnosis of POD, treated with sarecycline with a documented follow-up. Results: Six patients met inclusion criteria, all of which had shown improvement with no reported side effects. Of the six patients, four were female and two were male and the patient ages ranged from 26 to 58 years old (mean=41 years). The course of therapy ranged from 30 to180 days (median=90 days). Conclusion: Based on the outcomes, there are many potential benefits to treatment of POD with sarecycline over the alternative tetracycline-class antibiotics. There is a need for more large-scale clinical studies evaluating treatment options for POD. Based on the efficacy and tolerability of sarecycline in large- scale acne studies, sarecycline may be an appropriate novel treatment option for POD and should be explored further.

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Laser hair removal: a review.

BACKGROUND: Unwanted hair growth is a common aesthetic problem. Laser hair removal has emerged as a leading treatment option for long-term depilation. OBJECTIVES: To extensively review the literature on laser hair removal pertaining to its theoretical basis, current laser and light-based devices, and their complications. Special treatment recommendations for darker skin types were considered. MATERIALS AND METHODS: A comprehensive literature search related to the long-pulse alexandrite (755 nm), long-pulse diode (810 nm), long-pulse neodymium-doped yttrium aluminum garnet (Nd:YAG; 1,064 nm), and intense pulsed light (IPL) system, as well as newer home-use devices, was conducted. RESULTS: The literature supports the use of the alexandrite, diode, Nd:YAG and IPL devices for long-term hair removal. Because of its longer wavelength, the Nd:YAG is the best laser system to use for pigmented skin. Further research is needed regarding the safety and efficacy of home-use devices. CONCLUSION: Current in-office laser hair removal devices effectively provide a durable solution for unwanted hair removal.

Influence of Season on Efficacy and Tolerability of Tazarotene 0.045% Lotion for the Treatment of Acne.

Objective: The condition of the skin can vary due to weather fluctuations. Therefore, this post-hoc analysis evaluated efficacy and safety of tazarotene 0.045% lotion in warmer versus colder months. Methods: In two Phase III, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene or vehicle lotion. The pooled population (N=1,614) was stratified by randomization date (warmer=May to September; colder=October to April). Evaluations included inflammatory/noninflammatory lesion counts, treatment success, adverse events, and safety/tolerability. Results: Tazarotene 0.045% lotion was similarly efficacious over colder and warmer months. Compared with vehicle, tazarotene demonstrated significantly greater least-squares mean absolute reductions from baseline to Week 12 in inflammatory (colder/warmer tazarotene vs. vehicle: -16.6/-15.8 vs. -13.2/-12.9) and noninflammatory lesions (-23.2/-22.6 vs. -17.5/-15.1); treatment success rates were also significantly higher (30.1/30.8% vs. 18.2/17.6%) (P<0.001, all). No strong seasonal trends in safety were observed, though tazarotene led to slightly more discontinuations (3.4% vs. 1.9%) and related adverse events (12.0% vs. 10.3%) in colder versus warmer months. Transient increases in scaling, erythema, and itching at Weeks 2 to 8 of tazarotene treatment were slightly higher in colder versus warmer months but returned to baseline/improved by Week 12. Limitations: Geographical variation across study sites can lead to varying temperatures and humidity within the same months. Conclusion: Tazarotene 0.045% lotion was efficacious and well tolerated for acne treatment, regardless of season. Year-round tolerability of tazarotene 0.045% lotion may be due to its lower tazarotene concentration and polymeric emulsion technology, which simultaneously delivers moisturizers/humectants/emollients to skin.