Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study.

BACKGROUND: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. METHODS: In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 µg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. RESULTS: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. CONCLUSIONS: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. TRIAL REGISTRATION: Clinicaltrials.gov NCT04856904.

A Randomized, Controlled Trial of Trifarotene Plus Doxycycline for Severe Acne Vulgaris.

Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability. Results: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions (P<0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group (P=0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms. Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne.

Managing Rosacea in the Clinic: From Pathophysiology to Treatment-A Review of the Literature.

Rosacea is a chronic skin disease characterized by a waxing and waning course. It can encompass different symptoms including erythema, papules/pustules, telangiectasia, and phymata and sometimes secondary manifestations, such as itching, burning, or stinging. This article reviews recent changes in rosacea management. Discussion of relevant medical literature augmented with clinical expertise is also provided. Notably, while patients report that rosacea negatively impacts their emotional and overall well-being, they also tend to have low satisfaction with treatment and are prone to discontinuing therapy and/or using rosacea medications on an intermittent basis, thereby undermining treatment efficacy. Fortunately, the therapeutic armamentarium for rosacea is expanding, and experts now recommend a treatment approach that targets the presenting signs and/or symptoms, with the goal of achieving the greatest possible clearance. More so than in the past, several treatments can be used concurrently to best address the overall presentation of rosacea in an individual patient.

Recognizing Rosacea: Tips on Differential Diagnosis

Rosacea is a common chronic inflammatory dermatosis with a variety of clinical manifestations. Rosacea primarily affects the central face, and includes papules, pustules, erythema, telangiectasias, perilesional redness, phymatous changes, and even ocular involvement. Symptoms may vary among different patients and even vary over time in an individual patient. Central facial redness affects many adults and can be an indicator of the chronic inflammatory disease rosacea. Rosacea is a clinical diagnosis based on the patient's history, physical examination, and exclusion of other disorders. It is under-diagnosed, particularly in individuals with skin of color. The goal of this article is to provide clinicians with the tools and understanding needed to correctly identify rosacea and differentiate it from other conditions that have overlapping signs and symptoms. J Drugs Dermatol. 2019;18(9):888-894

Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin.

INTRODUCTION: Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV. METHODS: This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], weeks 4, 8, and 12), percent reduction in lesions (weeks 4, 8, and 12), and subject questionnaires (week 12). Safety assessments included adverse events (AEs) and tolerability. RESULTS: Mean IL counts were significantly reduced from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates. CONCLUSION: 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000

J Drugs Dermatol. 2018;17(3):264-273.

The Importance of Recognizing Yeast Acne Malessezia versus Propionbacterium.

We all know that acne vulgaris ' is very common. That is why it is called vulgaris which means common. We are wanting to present however that yeast acne is also common. In fact, yeast may be found on the skin in 75-98% of healthy people. Under particular biological conditions, homeostasis of the skin microbiome fails and growth of the fungi exceeds ideal levels. When this happens, "yeast acne" can occur. We feel that the incidence of yeast acne has been increasing in prevalence in our clinic, especially in young adult males, and so we wrote this paper in order to increase awareness.

The role of brimonidine tartrate gel in the treatment of rosacea.

Rosacea is a chronic cutaneous condition with a prevalence rate ranging from 9.6% to 22% in recent studies. Facial erythema (transient and permanent) is considered a common denominator that is frequently observed in all subtypes of rosacea and is estimated to affect more than 40 million people worldwide. Brimonidine tartrate is a selective α2-adrenergic receptor agonist and is the first topical treatment approved for facial erythema of rosacea. Clinical trials have demonstrated that brimonidine tartrate provided significantly greater efficacy, compared to vehicle, for the treatment of moderate to severe erythema of rosacea. In addition, brimonidine tartrate has demonstrated a rapid onset of effect, duration of action throughout the day, and good safety profile in studies of up to 1 year. This review critically discusses the role of brimonidine tartrate for the treatment of facial erythema of rosacea by examining both clinical study data and real-world dermatologist experiences across a wide spectrum of treated patients, and concludes that it is a significant therapeutic option in the management of an unmet need of this chronic condition.

The Role of Topical Brimonidine Tartrate Gel as a Novel Therapeutic Option for Persistent Facial Erythema Associated with Rosacea.

Rosacea is a chronic inflammatory skin condition that commonly presents with persistent facial erythema with or without the coincident presence of flushing, telangiectasias, inflammatory papules or pustules, phymatous changes, or ocular involvement. Patients often present with a constellation of various signs and symptoms of the disease, and an individualized treatment plan should be tailored to a patient's unique clinical presentation. Previously available medications for rosacea have all targeted the inflammatory erythematous papules and pustules frequently associated with the disease, leaving a therapeutic gap for the common manifestation of persistent facial erythema. Brimonidine tartrate 0.33% gel was approved by the US Food and Drug Administration in August 2013 as the first medication available for the topical treatment of persistent facial erythema associated with rosacea. Brimonidine gel is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive effects, which leads to significant reduction of persistent facial erythema in the majority of patients when applied once daily. Based on large-scale clinical trials and post-marketing reports, brimonidine gel has maintained a good safety profile with a minority of patients experiencing adverse effects from its use, most of which are cutaneous in nature, mild-to-moderate in degree, occur early after initiation of treatment, often resolve spontaneously with continued use, and generally resolve after discontinuation of use. Among the reported adverse effects, two distinct manifestations of worsened erythema have been described. Brimonidine gel can be integrated into a treatment regimen along with concomitant therapies for facial papules and pustules with no increased risk of adverse events with combination therapy. Education about optimal application methods, setting reasonable expectations for treatment, and minimizing inflammation are important factors for the successful use of brimonidine gel as part of a patient's overall rosacea treatment regimen.

Optimizing the use of topical brimonidine in rosacea management: panel recommendations.

Rosacea is a chronic inflammatory disease with a complex pathophysiology that manifests with central facial redness with or without papulopustular lesions. Often, patients with rosacea present with a constellation of signs and symptoms; for best results, the treatment plan should take into account all symptoms manifesting in the individual patient. The first available pharmacologic treatment to address the redness associated with rosacea is topical brimonidine. In the United States, brimonidine topical gel 0.33% is indicated for persistent facial erythema of rosacea; approval was based on clinically significant efficacy and good safety data from large-scale clinical trials. Use of brimonidine in routine clinical practice has yielded new insights that elaborate on the findings from clinical trials. For example, real-world use has shown that a percentage of patients (in our experience, approximately 10 to 20%) treated with brimonidine experience a worsening of erythema that has been called "rebound." Our routine use of this agent for >1 year has yielded strategies to set patient expectations, optimize treatment initiation, and minimize potential problems; this article details those strategies. Because we believe that the term "rebound" has been used to describe several physiologically distinct events, we have also proposed more specific terminology for such events.

Non melanoma skin cancer review.

The diagnosis of skin cancer is often distressing for the individual patient even though 20% of the population may develop a skin cancer during their life. As with most conditions, an ounce of prevention is worth a pound of cure. Employing sun smart behaviors in childhood that last into adulthood is a good place to start. Regularly scheduled full body skin exams by a health care provider in addition to monthly self skin check exams allow for early detection.

Self-reported treatment impressions and satisfaction of papulopustular rosacea patients treated with doxycycline, USP, 40 mg capsules.

OBJECTIVES: This survey program was designed to evaluate patients' experiences with doxycycline, USP, 40 mg capsules (30 mg immediate release, 10 mg delayed release beads, ORACEA®; Galderma Laboratories, L.P.) as a treatment for the inflammatory lesions of rosacea and to provide patient-reported feedback to physicians. METHODS: This prospective, cross-sectional survey was implemented in January 2010. One thousand, two hundred and ninety-five physicians identified patients eligible for treatment with doxycycline, USP, 40 mg capsules and provided them with information about the program. Patients voluntarily participated by contacting a program coordinator or by enrolling online, providing consent, and responding to a series of questions prior to medication use and approximately four weeks post-treatment initiation. Surveys were completed through an automated interactive voice response system or a dedicated, secure website and included questions regarding patients' perceptions of when the treatment first started working, patients' symptom severity, interference of symptoms with work and social activities, and confidence in appearance. Patients were also asked about prior medication use, adjunct medication use, and treatment satisfaction. Reports of patient progress and responses to these survey questions were sent directly to each patient's treating physician within a few days of survey completion. Paired t-tests were used to evaluate the statistical significance of differences in symptom severity, interference and confidence ratings before and after treatment. RESULTS: Two thousand, eight hundred ninety-eight patients enrolled in the survey program and completed the baseline survey. Of these, a total of 1,346 patients completed the baseline and four-week survey (mean age 50 years; 75% female). Most (58%) reported use of a prior prescription medication to treat rosacea. Over half the patients (52%) responded that the product began to work within two weeks of use. After four weeks of using doxycycline, USP, 40 mg capsules, patients felt that the severities of redness as well as bumps/blemishes were significantly reduced (P<.05). Patients also reported having more confidence with their skin's appearance (P<.05). In addition, with use of doxycycline, USP, 40 mg capsules, patients reported significant reductions in the interference of symptoms with work and social activities (P<.05). Satisfaction with doxycycline, USP, 40 mg capsules averaged 6.8 on a scale of 1 (not at all satisfied) to 9 (very satisfied) for patients using only doxycycline, USP, 40 mg capsules; mean satisfaction was 6.7 for those using it with adjunct medication. Seven patients reported 11 adverse events during the program, including lack of efficacy, joint injury with fatigue, dizziness, back pain, bloating and constipation, increased facial redness and pimples, yeast infection, sore throat, increased bruising and worsening of rosacea. CONCLUSION: Satisfaction with doxycycline, USP, 40 mg capsules for the treatment of papulopustular rosacea was apparent from patient-rated measures of treatment impact. Patients with papulopustular rosacea reported improvement in symptoms, reductions in the interference of symptoms with life's activities and satisfaction with treatment with doxycycline, USP, 40 mg capsules.

Cutaneous warts: an evidence-based approach to therapy.

Cutaneous warts are a common presenting complaint in children and adolescents. Common, plantar, or flat warts are cutaneous manifestations of the human papillomavirus. The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient. As a result, many different approaches to wart therapy exist. These approaches are discussed to demonstrate the evidence supporting common therapies and provide a guideline for physicians. Evidence supports the at-home use of topical salicylic acid and physician-administered cryotherapy. Intralesional immunotherapy for nongenital cutaneous warts may be an option for large or recalcitrant warts.

Topical treatment for atopic dermatitis in the 21st century.

Atopic Dermatitis (AD) is a common cutaneous inflammatory disease. Recent estimates of prevalence in United States school children range from 10-20%. Topical treatment of AD is unsatisfactory. Now two new topical agents, tacrolimus and pimecrolimus, are revolutionizing the treatment of AD. Here we review AD as well as these breakthrough therapies.

A double-blind comparative study of sodium sulfacetamide lotion 10% versus selenium sulfide lotion 2.5% in the treatment of pityriasis (tinea) versicolor.

Pityriasis (tinea) versicolor, which consists of hyperpigmented and hypopigmented scaly patches, is often difficult to treat. A double-blind comparative study between once-a-day sodium sulfacetamide lotion and selenium sulfide lotion was undertaken. Both treatments were safe and efficacious. Selenium sulfide was statistically more efficacious (76.2% vs 47.8%, P=.013).