Natural Moisturizing Factor-Enriched Formulations Compared to a Ceramide-Based Cream.

BACKGROUND: We aimed to investigate the effects of 2 ceramide plus natural moisturizing factor-enriched formulations compared to a ceramide-based cream on skin moisturization. METHODS: Two double-blinded comparative studies were conducted, which enrolled 35 (n=29 females, n=6 males) and 33 (n=21 females, n=12 males) participants, respectively. Participants applied ceramide plus natural moisturizer cream or ceramide-based cream (study 1) or applied ceramide plus natural moisturizing factor lotion or ceramide-based cream (study 2) to each of their lower legs for 10 days with a 5-day regression period (no moisturizer applied). Skin hydration by corneometry after bilateral application was conducted once daily for each leg in both groups.   Results: An increase in corneometer units vs baseline for the ceramide plus natural moisturizing factor-enriched cream and natural moisturizing factor-enriched lotion were greater than the increase vs baseline for the ceramide-based cream at days 10 and 15; with an overall statistical significance in favor of the ceramide plus natural moisturizing factor-enriched formulations at day 10.  Conclusions: The marked improvement in skin moisturization following utilization of the ceramide plus natural moisturizing  factor-enriched cream and lotion compared to the ceramide-based cream can be attributed to the inherent properties of the natural moisturizing factors. These properties are known to maintain the humectancy and intercellular lipid membrane of the stratum corneum, which directly improves the permeability barrier function of human skin in reducing transepidermal water loss. J Drugs Dermatol. 2024;23(3):     doi:10.36849/JDD.8172.

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.

Fifty Years of Minocycline and Its Evolution: A Dermatological Perspective.

2021 is the 50th anniversary of the FDA approval of minocycline (MCN). While many other antibiotics have become obsolete during this time, MCN continues to be quite useful. In dermatology, MCN is used prominently in acne vulgaris, and is also employed in many other dermatological conditions because of its molecular and pharmacological properties. In this article, we review the history of minocycline, and outline the evolution of the drug since its inception. Based on its existing longstanding utility and continued innovations in formulation and delivery systems, we postulate that it will continue to have a prominent position in the dermatologist’s armamentarium. J Drugs Dermatol. 2021;20(10):1031-1036. doi:10.36849/JDD.6370.

Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: Review and clinical practice experience.

Rosacea has been reported less frequently among individuals with skin of color than in those with white skin, but rosacea is not a rare disease in this population. In fact, rosacea might be underreported and underdiagnosed in populations with skin of color because of the difficulty of discerning erythema and telangiectasia in dark skin. The susceptibility of persons with highly pigmented skin to dermatologic conditions like rosacea, whose triggers include sun exposure, is probably underestimated. Many people with skin of color who have rosacea might experience delayed diagnosis, leading to inappropriate or inadequate treatment; greater morbidity; and uncontrolled, progressive disease with disfiguring manifestations, including phymatous rosacea. In this article, we review the epidemiology of rosacea in skin of color and highlight variations in the clinical presentation of rosacea across the diverse spectrum of patient populations affected. We present strategies to aid in the timely diagnosis and effective treatment of rosacea in patients with skin of color, with an aim of promoting increased awareness of rosacea in these patients and reducing disparities in the management of their disease.

Highlights of Skin Disease Education Foundations 42nd Annual Hawaii Dermatology Seminar.

Updates on managing some of the most common dermatologic conditions for which patients seek care illuminated presentations at the Skin Disease Education Foundation's 42nd Annual Hawaii Dermatology Seminar®. This educational supplement summarizes the highlights of clinical sessions presented during this CME/CE conference. Treatment of psoriasis has continued to advance, with three interleukin (IL)-17 antagonists approved by the US Food and Drug Administration (FDA) and a fourth in phase 3 trials. An authority on the use of biologics in psoriasis presents current data on the safety and efficacy of these therapies. Tumor necrosis factor (TNF) inhibitors also retain a place in the management of psoriasis, with records of long-term safety. A fourth TNF inhibitor awaits FDA approval for use in psoriasis, offering data on transmission during pregnancy and lactation. An expert on the use of this drug class presents the evidence. Topical therapies remain the cornerstone of care for many patients with psoriasis as well as those with rosacea. Our faculty update readers about new and investigational topical therapies for moderate or severe psoriasis, as well as for acne and rosacea. The current literature on monitoring patients receiving isotretinoin also is summarized. Aesthetic and cosmetic dermatology services form a sizable portion of some practices. Our faculty review data on safety of topical and procedural therapies for cellulite as well as safe injection of facial fillers.

Evidence-based recommendations for the management of acne fulminans and its variants.

BACKGROUND: Acne fulminans (AF) is a severe variant of inflammatory acne. It typically manifests as an explosive worsening and ulceration of skin lesions, and can be associated with systemic symptoms. However, there is a paucity of evidence-based information and no clear guidelines concerning the classification and treatment of AF. OBJECTIVE: To better define the spectrum of AF and its variants, devise optimal therapeutic approaches, and identify areas of future research. METHODS: A panel of physicians with expertise in severe acne vulgaris was convened after a comprehensive literature review of severe acne variants. Priority topics were reviewed and presented by each panelist at a 5-hour conference. Following review of the audiotape and scribed notes from the conference, surveys were utilized to address points of controversy and to clarify consensus recommendations. RESULTS: Appropriate clinical case presentations and consensus survey questions were utilized to create final recommendations based on both the literature and the expert consensus. LIMITATIONS: Limited evidenced-based data and prospective studies in the literature concerning the treatment of AF is available. CONCLUSION: These guidelines better characterize AF and provide health care practitioners approaches to the classification, treatment, and prevention of AF and its variants.

Management of Severe Acne Vulgaris With Topical Therapy.

Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Although rare in childhood, severe acne can affect up to 12% of the adolescent population. A chronic disease, it requires both aggressive management and effective maintenance strategies. Oral antibiotics, in combination with topical agents are recommended for treatment, with topical agents being continued as maintenance therapy to minimize resistance and recurrence. However, concerns with systemic side effects have recently resulted in a greater focus on the potential of fixed combination topical therapies to treat severe acne. Here we review the available clinical evidence. There are no studies investigating the use of fixed combination topical therapy exclusively in severe acne. However, studies assessing the treatment of moderate-to-severe acne include subpopulation data in severe patients. Adapalene 0.3%-benzoyl peroxide (BP) 2.5% was found to be effective in patients with severe acne, whereas the fixed combination with a lower concentration of adapalene (0.1%) was no more effective than vehicle. Clindamycin-BP 1.2%/3.75% gel and clindamycin-BP 1.2%/2.5% gel were both found to be effective in severe acne with an apparent BP-dose response. Clindamycin phosphate 1.2%-tretinoin 0.025% demonstrated similar efficacy in severe acne, but with little benefit over individual monads. Realistic topical treatment options now exist for the management of severe acne where patient and physician preference can impact positive outcomes.

J Drugs Dermatol. 2017;16(11):1134-1138.

The Role of Cutaneous Microbiota Harmony in Maintaining a Functional Skin Barrier.

The skin is constantly exposed to various endogenous and exogenous factors that may impact its barrier function at the physical, mechanical, immunological, and microbial levels. These factors have the potential to initiate or exacerbate a variety of inflammatory skin conditions, especially those associated with barrier dysfunction. The barrier function of the skin depends upon a symbiotic relationship between resident microbial communities and host tissue. This symbiosis results from complex signals involved in both the innate and adaptive immune responses. Recent research indicates that both bacterial diversity and the relative abundance of different microbes present on and in the skin, may contribute to skin barrier stability or dysfunction. The objectives of this review are to discuss the relationship between the skin microbiota and skin barrier function and to consider mechanisms that may help its preservation. J Drugs Dermatol. 2017;16(1):12-18..

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.

Stratum Corneum Abnormalities and Disease-Affected Skin: Strategies for Successful Outcomes in Inflammatory Acne.

Stratum corneum (SC) abnormalities are associated with disease-affected skin conditions such as inflammatory acne. Current topical acne treatment options including benzoyl peroxide and retinoids can worsen the barrier dysfunctions by increasing transepidermal water loss, depleting SC vitamin E levels, and relatively decreasing SC thickness. However, strategies exist to employ these treatments in a more effective manner and lessen barrier function disruption including use of less irritating vehicles or concomitant application of moisturizers. Patients also play a role in the outcome of their skin barrier function based on their compliance and administration technique. By increasing patient compliance and proper application of treatments, patient skin barrier function can improve. Additionally, future treatments are on the horizon that may customize acne therapy at a molecular level.

J Drugs Dermatol. 2016;15(10):1170-1173.

Impact of female acne on patterns of health care resource utilization.

BACKGROUND: Limited data are available on acne treatment patterns in females through their adult years. OBJECTIVE: The purpose of this analysis was to evaluate health care resource utilization (HRU) and treatment patterns in cohorts with and without the use of acne medication and predictors of use. METHODS: A cross-sectional, web-based survey was administered to US females (25-45 years) with facial acne (≥ 25 visible lesions). Data collected included: sociodemographics and self-reported clinical characteristics, acne treatments, and health care professional (HCP) visits. Subject characteristics associated with medication use were examined by logistic regression. RESULTS: Approximately half of the total sample (N=208, mean age: 35 ± 6) ever visited an HCP for acne and reported more over-the counter (OTC) medication use (51.0%) than prescription (Rx) medication use (15.4%). Subjects did not use medications daily, averaging from 12-18 days over the previous 4 weeks. Logistic regression showed that race and prior HCP visits for acne were significant predictors of medication use (P<.05). CONCLUSIONS: Adult females generally self-treated their acne using primarily OTC medications; however, poor compliance was observed for Rx and OTC. Race and prior HCP visits for acne were significant predictors of current medication use.

Pharmacologic Treatment Options in Mild, Moderate, and Severe Acne Vulgaris.

Most patients with acne have a disease that responds to acute treatment and can be controlled long term with a maintenance regimen of topical therapy. It is the minority of patients-generally, but not exclusively-the most severely affected, who respond poorly to acute therapy and require continued systemic therapy. The goals of therapy are resolution of visible lesions, prevention of new lesions, avoidance of scarring, and improvement of patient quality of life. Treatment choices are made on the basis of lesion type, number, and size, with consideration given to the presence of physical and psychological scarring. Semin Cutan Med Surg 34(supp5):S82-S85.

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.

40 years of topical tretinoin use in review.

Topical tretinoin has been approved for use in dermatology for 40 years and is currently approved for the treatment of acne vulgaris and photodamage. During this time, topical tretinoin has accumulated significant efficacy and safety data in the treatment of acne and photodamaged skin and demonstrated clinical potential for treating a range of other dermatologic conditions. The diverse effects may be due to complex underlying mechanisms of action associated with tretinoin, including keratolytic activity, collagenesis, and other mechanisms associated with the activation of nuclear retinoic acid receptors (RARα, RARß, and RARγ). In this article, we review the history of topical tretinoin use to date and outline emerging research suggesting that topical tretinoin may have potential clinical use for treating a multitude of other dermatological conditions when used either as monotherapy or in combination with other agents. We also describe newer formulations of topical tretinoin that have been designed to reduce irritation potential. In light of the substantial history of safety and efficacy of topical tretinoin in acne and photodamage, we speculate that it holds promise in treating many additional dermatological conditions, which may be explored in future research.

Diagnosis and treatment of rosacea: state of the art.

Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in 1 of every 10 adults in a primary care waiting room. Untreated, patients with rosacea can suffer significant emotional, workplace, and social impairments. While rosacea has been recognized since ancient times, only recently have investigators begun to identify the pathophysiologic elements responsible for the characteristic erythema, flushing, dysesthesias, and papulopustular manifestations of the disease. Although the etiology of rosacea is unclear, inflammation appears to be a central element. Experimental evidence suggests that abnormalities of the skin's innate and adaptive immune responses may play pivotal roles. Once recognized, effective topical and systemic therapies can be prescribed to lessen the impact of the disease on the patient's life. Although initially administered in an empiric fashion, it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather than their antimicrobial properties. Consequently, practitioners have the opportunity to practice good antibiotic stewardship when treating the disease, particularly with systemic therapies. Therapy with subantimicrobial dosing and with topical treatments can modulate the inflammation of rosacea without exerting antibiotic pressure responsible for the emergence of antibiotic resistance.

Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune response in rosacea-prone skin.

The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.

Tazarotene 0.045% Lotion for Moderate-to-Severe Acne in Male and Female Participants: A Phase II Post-hoc Analysis.

CLINICAL TRIALS ID: NCT02938494 BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS: Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [-70.3% vs. -56.2%]; noninflammatory [-60.0% vs. -53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION: Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature.

A community-based study of the effectiveness of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) on quality of life and satisfaction with treatment in participants with rosacea.

Changes to the skin of the face in patients with rosacea have the potential to substantially impair multiple domains of quality of life (QOL); however, the number of publications providing evidence for this topic is limited. This 12-week, open-label, community-based, phase 4 trial of 1421 participants is the largest study of the disease to date. It explores the effects of mild to severe rosacea and its treatment on QOL. Participants were treated with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) as monotherapy or add-on treatment to existing topical therapy. This article examines QOL issues in the primary analysis population consisting of 966 participants who completed the trial without a major protocol violation. Quality of life was assessed at baseline and study end (week 12) with the RosaQoL, a validated 21-question instrument. Participant and investigator satisfaction with treatment also were evaluated. In the monotherapy group, the mean RosaQoL score was 3.3 at baseline and 2.8 at end of study. In the add-on therapy group, the mean RosaQoL score was 3.2 at baseline and 2.8 at end of study. The improvement in QOL was both clinically and statistically significant (P < .0001) and was similar in both monotherapy and add-on therapy groups. Most participants expressed satisfaction with treatment and approximately 90% of the community-based investigators reported that they were likely or very likely to continue prescribing this formulation. The study demonstrates that the impaired QOL in patients with rosacea can be substantially improved during a 3-month period by once-daily treatment with the anti-inflammatory activity of subantimicrobial-dose doxycycline.