Use of Dapsone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Dapsone 5% Gel Combination Treatment.

Background: Acne vulgaris is a common, chronic skin disease that requires long-term therapy. Oral antibiotics are a mainstay of treatment, but extended use is associated with the development of bacterial resistance. Topical therapies are often combined with oral antibiotics to achieve an initial improvement, after which the oral agents may be discontinued and the topical therapy used as maintenance.

Randomized, Double-Blind, Split-Face Study to Compare the Irritation Potential of Two Topical Acne Formulations Over a 21-Day Treatment Period.

The use of fixed combinations in acne vulgaris (acne) is very common, however comparative clinical trial data are limited. Cutaneous tolerability can influence patient compliance, and concerns about skin irritation with topical acne treatments have lead to a number of comparative split-face studies. Recently, a new fixed combination product was introduced (clin 1.

Advances in the Understanding of the Pathogenesis of Inflammatory Acne.

Acne vulgaris (AV) is the most common skin disorder. It was traditionally thought that AV lesions developed after abnormal desquamation of the keratinocytes that line the sebaceous follicle, leading to hyperkeratinization and microcomedone formation. However, in recent years there has been a paradigm shift with regard to understanding the pathogenesis of AV, and it is now viewed as a primary inflammatory skin disorder.

Evolution of Acne Assessments and Impact on Acne Medications: An Evolving, Imperfect Paradigm.

Background: Outcomes for success in acne interventional trials include statistically significant differences from baseline between treatment arms in lesion counts (comedonal, inflammatory and/or total) and in thresholds of categorical improvement in investigator global assessments (IGA).

Objectives: We evaluated differences in outcome measures and definition of success in acne trials; and their impact on FDA approval and indications for acne medications.

Methods: Review of acne clinical trial literature, prescribing information and regulatory guidelines for currently approved acne medications in the United States.

The Power of Combination Topical Therapy for Psoriasis.

Psoriasis is a chronic inflammatory skin disease where the use of topical corticosteroids is a mainstream treatment. However, the continuous use of high potency topical corticosteroids is limited by a variety of well known adverse events which include, atrophy, and telangiectasia. Also, inhibition of lipid synthesis by steroids can cause impairment of the epidermal barrier, which is already disrupted in most of the inflammatory cutaneous disorders such as psoriasis.

Differences in psoriasis signs and symptom severity between patients with clear and almost clear skin in clinical practice.

Introduction: In psoriasis clinical trials, treatment success is often defined as achieving a static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear). Patients with clear versus almost clear skin may experience psoriasis differently. This study assessed whether aggregating these patients underestimates subjective improvements associated with total skin clearance.

Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis.

Background: Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis.

Methods: In two phase 3 studies (AMAGINE-2 and AMAGINE-3), patients with moderate-to-severe psoriasis were randomly assigned to receive brodalumab (210 mg or 140 mg every 2 weeks), ustekinumab (45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg), or placebo. At week 12, patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks, every 4 weeks, or every 8 weeks; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks, and patients receiving placebo received 210 mg of brodalumab every 2 weeks.

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1).

Background: Apremilast works intracellularly to regulate inflammatory mediators.

Objective: ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis.

Methods: This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo.

Evolving perspectives on the etiology and pathogenesis of acne vulgaris.

As the pathophysiology of acne is complex and multifactorial, the continued influx of new basic science and clinical information requires careful analysis before drawing conclusions about what truly contributes to the development and progression of this chronic disease. Our objective is to review the latest evidence and highlight a number of important perspectives on the pathophysiology of acne. An improved understanding of acne pathogenesis should lead to more rational therapy and a better understanding of the role of P acnes opens new perspectives for the development of new treatments and management.

Onychomycosis: epidemiology, diagnosis, and treatment in a changing landscape.

Onychomycosis is an often overlooked and/or undertreated disease. This may be in part due to an under appreciation among both physicians and patients of its impact on quality of life and the potential for significant complications, from tinea corporis and cruris, to bacterial superinfection. Some health care providers are unaware of the effective low-risk treatments currently available.

Comparative efficacy and tolerability of dapsone 5% gel in adult versus adolescent females with acne vulgaris.

Objective: To determine whether the response to dapsone 5% gel was similar in adolescent girls and adult women with facial acne vulgaris.

Design And Setting: Subgroup analysis of female subjects with acne vulgaris receiving active treatment enrolled in two randomized, double-blind Phase 3 clinical trials.

Treatment: Twice-daily applications of dapsone 5% gel over 12 weeks.

Update on the management of rosacea: a status report on the current role and new horizons with topical azelaic acid.

Azelaic acid (AzA) 15% gel has been available in the United States for slightly over a decade, approved for treatment of the inflammatory lesions (papules and pustules) of rosacea. Efficacy and safety have been established in multiple studies both as monotherapy and in combination with oral doxycycline. Azelaic acid 15% gel has been shown not to induce epidermal permeability barrier impairment, and proper skin care reduces the likelihood of neurosensory adverse effects of stinging and burning that can affect a subset of patients with rosacea.

Effect of skin barrier emulsion cream vs a conventional moisturizer on transepidermal water loss and corneometry in atopic dermatitis: a pilot study.

The repair and maintenance of the epidermal barrier is of the utmost importance in the treatment of atopic dermatitis (AD). While barrier creams and emollients are considered to be a foundation of AD therapy, there is little comparative data between various product options. This was a pilot study with a small sample size to investigate the use of skin barrier emulsion cream vs a commonly used moisturizing lotion to improve the epidermal barrier in subjects with atopic dermatitis.

Enhancing transungual delivery and spreading of efinaconazole under the nail plate through a unique formulation approach.

Onychomycosis is a very common nail disorder seen in dermatological practice. It is difficult to treat successfully for a multitude of reasons, and although topical antifungal therapy might be considered ideal for mild to moderate onychomycosis, efficacy has been limited by poor nail penetration of active ingredient through the nail plate into the nail bed and nail matrix to the site of infection. The intrinsic properties of an antifungal and its vehicle formulation are both considered important contributors to effective treatment.

Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.

Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR.

The importance of photoprotection and moisturization in treating acne vulgaris.

Skin care products are recognized by dermatologists as critical adjunctive therapeutic modalities for patients suffering from acne vulgaris (AV). Prescribing an acne medication without reviewing a patient's skin care regimen can lead to poor compliance, intolerable side effects, and resulting patient and physician frustration. Striking that delicate balance between maintaining the skin barrier while controlling oil and shine has always been a challenge when treating this chronic inflammatory condition, and it necessitates a unique set of ingredients and formulation.

Transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product: focus on clocortolone pivalate 0.1% cream.

Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur.

Re-evaluating treatment targets in acne vulgaris: adapting to a new understanding of pathophysiology.

Two primary factors are changing current approaches to the management of acne vulgaris (AV): the continuously evolving role of Propionibacterium acnes in the pathophysiology of AV and recent evidence of an inflammatory basis for AV via innate immunity. The developing concepts emphasize that acne is primarily an inflammatory disease. The emerging concept of subclinical inflammation and its effect on development and progression of acne lesions correlating with the sequence of the underlying inflammation process has been a major change in our understanding of acne pathogenesis.

The effect of desonide hydrogel on pruritis associated with atopic dermatitis.

Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most AD patients. Instead, anti-inflammatory agents are used to reduce inflammation and therefore improve associated itch.