Search

Background A three-pronged approach to acne treatment—combining an antibiotic, antibacterial, and retinoid—could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. Objectives We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. Methods In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. Results A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8–30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6–26.8; noninflammatory, 21.8–30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. Conclusions Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. Clinical Trial Registration ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017). Supplementary Information The online version contains supplementary material available at 10.1007/s40257-021-00650-3.

Acne vulgaris is a common inflammatory disease. Among patients with darker skin phototypes (Fitzpatrick III–VI), the inflammatory processes of acne stimulate excess melanogenesis and abnormal melanin deposition, leading to pigmentary sequelae known as post-inflammatory hyperpigmentation and post-inflammatory erythema in all skin tones, although post-inflammatory hyperpigmentation is more common in darker skin and post-inflammatory erythema in lighter skin. These pigmentary alterations can be long lasting and are often more distressing to patients than the active acne lesions. This article discusses what is known about acne-related pigmentation, much of which is extrapolated from general study of nonspecific pigment deposition. Because dyspigmentation poses both a significant clinical concern to patients and a therapeutic challenge to clinicians, we formed a working group consisting of pigmentary experts with the aim of increasing awareness and education of acne-related pigmentary sequelae.

Rosacea is one of the most common inflammatory skin diseases in the United States, with a complex pathophysiology. One of the major components of the pathophysiology of rosacea is an abnormal immune detection and response to stimuli. Tetracyclines and their derivatives, including minocycline and doxycycline, have anti-inflammatory properties independent of their antibacterial activity that correlate with certain aspects of the pathophysiology, and these drugs are often used by dermatologists to treat rosacea. Biological actions of tetracyclines correlating with rosacea include anti-inflammatory and antioxidative activities, inhibitory effects on angiogenesis, and proteolysis. The objective of this review is to re-establish the current understanding of tetracyclines and their mechanism of action as they relate to the pathophysiology and treatment of rosacea for clinicians. This includes reviewing the inflammatory aspects of rosacea that correlate with the known nonantibiotic properties of tetracyclines and providing the most up-to-date clinical evidence supporting the use of tetracyclines to treat rosacea. Given the evolving and multifactorial nature of pathophysiology, this review offers clinicians a unified picture that includes research on the links between rosacea pathophysiology and clinical presentation, the nonantibiotic properties of tetracyclines that relate to pathophysiologic pathways in rosacea, and the potential for clinical application of tetracyclines in rosacea therapy.

Molluscum contagiosum (molluscum) is a common skin condition, especially in children, yet treatment approaches by US health care practitioners vary widely. A dearth of clinical data from large, well-controlled studies has resulted in significant gaps in knowledge, including treatment guidelines and algorithms. As of this writing, there are no FDA-approved treatments for molluscum. The objective of this review is to provide practitioners with expert, evidence-based information and guidance about treatment approaches for, and the special circumstances faced by, patients with molluscum. To this end, a group of five pediatric and adult dermatologists collectively identified treatments and special considerations they felt were most commonly used to treat molluscum. Hence, in the first part of the review, seven treatment approaches identified as the most important to review (e.g., curettage, cantharidin) are discussed in terms of their mechanisms of action, supporting clinical data, and rationale for use. Each treatment approach concludes with aldquo;clinical pearlsrdquo; section, which summarizes the grouprsquo;s experiences with the treatment. In the second part, five special considerations (e.g., atopic dermatitis, skin of color) are discussed with supporting clinical data and are also followed by aldquo;clinical pearlsrdquo; summary. J Drugs Dermatol. 2021;20(11): 1185-1190. doi:10.36849/JDD.6383.

Background Acne affects more than 80% of adolescents and young adults, who most often develop acne scars. Supporting data on the effect of acne scars on patient’s health-related quality of life (HRQOL) are limited. Objective The aim was to determine how the severity of acne scars impacts the HRQOL of afflicted individuals. Methods In this population-based cross-sectional study, 723 adults with facial acne scars but without active acne lesions self-completed the Self-assessment of Clinical Acne-Related Scars (SCARS) questionnaire formulated to investigate degree of acne scarring. The Facial Acne Scar Quality of Life (FASQoL), Dermatology Life Quality Index (DLQI), and Dysmorphic Concern Questionnaire (DCQ) were completed to assess the attitude of these patients toward their scars and the impact of scarring on their HRQOL. Results The mean (standard error) DLQI score for facial acne scars was 6.26 (0.22). Acne scars were considered a ‘very large’ or ‘extremely large’ concern by 19.3% of participants with mild scars as compared to 20.1% and 34.0% of participants with moderate and severe/very severe scars, respectively (P = 0.003). Higher FASQoL scores were associated with increased severity of scarring (P = 0.001). In total, 16.9% of participants had clinical features of dysmorphia (i.e., DCQ > 13). DCQ scores were significantly higher among participants with more severe scarring (mean DCQ score of 8.04 [0.28], 8.40 [0.18], and 10.13 [0.08] among participants with mild, moderate, and severe/very severe acne scars, respectively; P = 0.001). Most commonly reported signs of emotional distress were self-consciousness (68.0%) and worry about scars not going away (74.8%). Conclusions This study highlights the significant psychosocial impact of atrophic acne scars in the form of embarrassment and self-consciousness. Individuals with mild scars also expressed significant impact on quality of life that increased with aggravation of scar severity. Patient-reported outcomes provide an insight into the physical, functional, and psychological impact of acne scarring from the patient’s perspective. Supplementary Information The online version contains supplementary material available at 10.1007/s40257-021-00628-1.

FMX101 4% minocycline is a hydrophobic, topical foam formulation of minocycline recently approved by the United States Food and Drug Administration (FDA) for the treatment of non-nodular inflammatory lesions in moderate-to-severe acne vulgaris. It was developed to harness the anti-inflammatory and antibiotic activity of minocycline while minimizing potentially serious systemic adverse events associated with oral delivery. The composition and profile of this novel treatment have yet to be described. This article discusses the components of the foam-based product and the rationale for their selection. It reviews microbiologic data for FMX101 4% and presents previously unpublished data regarding sebum penetration, minocycline permeation, and disposition into skin structures. The effects of FMX101 4% were compared with those of several commercially available acne preparations to determine how the FMX101 4% formulation affects the physical properties of model human sebum in vitro. The hydrophobic formulation of FMX101 4% was found to lower the melting temperature of model human sebum below that of normal skin temperature, decreasing its viscosity. FMX101 4% achieved high concentrations of minocycline in the sebaceous appendage, while minimizing permeation beyond the dermal layer. Finally, this article summarizes efficacy and safety data for FMX101 4% from three Phase III studies (FX2014-04, FX2014-05, and FX2017-22). FMX101 4% appeared to be safe, effective, and well tolerated for the treatment of non-nodular inflammatory lesions in moderate-to-severe acne vulgaris. In conclusion, the topical formulation of minocycline in FMX101 4% represents a unique treatment for acne vulgaris and a viable alternative to oral administration.

Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P

Acne-focused dermatology expert groups have consistently recommended that most patients with acne be treated with a combination of topical retinoid and antimicrobial therapy. This is based on clinical data as well as evidence that these drug classes have different and complementary mechanisms of action that target multiple aspects of acne’s complex pathophysiology. Recent evidence-based guidelines for acne, including those from the American Academy of Dermatology (AAD) and the European Dermatology Forum (EDF), have agreed that retinoids have an essential role in this widespread disease. The AAD states “retinoids are the core of topical therapy for acne because they are comedolytic, resolve the precursor microcomedone lesion, and are anti-inflammatory;” further, they “allow for maintenance of clearance.” Despite uniform recommendation for use of topical retinoids, a recent study of prescribing practices from 2012 to 2014 indicated that dermatologists prescribed retinoids just 58.8% of the time while non-dermatologists prescribed them for only 32.4% of cases. In this article, we review the reasons supporting retinoids as the mainstay of acne therapy and discuss some of the perceived barriers that may be limiting use of this important drug class. Further, we discuss how and when titrating retinoid concentrations may be utilized in clinical practice. Funding: Galderma International.

Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. Safety concerns have limited use to 2 to 4 weeks. The objective of our study was to investigate the safety and efficacy of once-daily halobetasol propionate (HP) lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was treatment success (at least a 2-grade improvement in baseline investigator global assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional assessments included improvement in psoriasis signs and symptoms, body surface area (BSA), and a composite score of IGA×BSA. Safety and treatment-emergent adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% demonstrated statistically significant superiority over vehicle as early as week 2 and also was superior in reducing psoriasis signs and symptoms and BSA involvement.

Background A need exists for topical treatments in managing more severe inflammatory acne. Objectives The objectives of this study were to evaluate the efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) topical gel in subjects with moderate and severe inflammatory acne. Methods This was a multicenter, randomized, double-blind, parallel-group study. Randomization was stratified by acne severity (50 % moderate and 50 % severe). Subjects received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the percentage of subjects rated ‘clear’ or ‘almost clear’ with at least a 2-grade improvement on Investigator’s Global Assessment [IGA]) and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms. Results A total of 503 subjects were randomized: 217, 217, and 69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. For success rate (subjects rated ‘clear’ or ‘almost clear’ with ≥2-grade improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8–32.6, p

not available.

not available.

Background Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Objectives Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Methods Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. Results In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P Limitations Adjunctive topical or systemic treatments were not studied. Conclusion These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.

FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.Two identical phase 3 studies were conducted. Subjects were randomized 2:1 to once-daily FMX101 4% or foam vehicle for 12 weeks. The coprimary end points were the change in inflammatory lesion count from baseline and the rate of treatment success according to the Investigator's Global Assessment (a score of 0 or 1 for clear or almost clear, with a ≥2-grade improvement) at week 12.A total of 961 subjects were enrolled (study 04, N = 466; study 05, N = 495). Compared with vehicle, FMX101 4% demonstrated a significantly greater reduction in inflammatory lesions in both studies (P .05) and a greater rate of treatment success in study 05 according to the Investigator's Global Assessment (P .05). Pooled analyses of the 2 studies demonstrated statistical significance for both coprimary end points (all P .05). Noninflammatory lesion count was also significantly reduced with FMX101 4% versus with vehicle in both studies. FMX101 4% was generally safe and well tolerated. Skin-related adverse events were reported in less than 1% of subjects treated with FMX101 4%.Longer-term efficacy and safety outcomes are needed (ongoing).FMX101 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved Investigator's Global Assessment scores in patients with moderate-to-severe acne.

pBackground: Actinic keratosis (AK) can affect large skin areas. Ingenol mebutate (IngMeb) gel (0.015% and 0.05%) is approved for topical treatment of AK in a single contiguous area of ~25 cm2./ppObjective: The study sought to determine the maximum tolerated dose (MTD), efficacy, and tolerability of IngMeb applied to AK on a contiguous area less than equal to 250 cm2./ppMethods: Part 1 determined the MTD of IngMeb at 7 concentrations for 2 or 3 days. Part 2 assessed efficacy and tolerability at the MTD and one dose lower for 2 or 3 days vs vehicle./ppResults: Four dosing regimens with an acceptable benefit-to-risk ratio were identified: 0.018% and 0.027% once daily for 2 or 3 days. Complete clearance at 8 weeks was achieved by 21.3% to 39.1% of IngMeb-treated patients vs 0% to 3.2% treated with vehicle. Composite local skin response scores peaked on the day after the last application, rapidly declined, and were near baseline at 2 weeks. Adverse events were predominantly mild or moderate./ppLimitations: The study evaluated a limited number of doses in a population of only white patients./ppConclusion: IngMeb gel was effective and well tolerated as field treatment of AK on the full face, full scalp, and up to 250 cm2 on the chest./ppemJ Drugs Dermatol. 2017;16(5):438-444./em/p.

not available.

Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.br /The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.br /This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.br /The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of "none" for stinging/burning, dryness, scaling, and erythema scales at all time points.br /Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.br /br /emJ Drugs Dermatol/em. 2016;15(5):553-561.

A novel formulation of 0.05% betamethasone dipropionate in an emollient spray vehicle (DFD-01) was developed to deliver steroid to the skin layers most affected by psoriasis.To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks.Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10-20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥ 2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15.Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13-14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P0.001) and Study 2 (P=0.002), and at day 29 (both studies P0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks.These studies demonstrate DFD-01's excellent efficacy and safety for the treatment of extensive psoriasis (10-20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.

Background There are multiple global scales for acne severity grading but no singular standard. Objective Our objective was to determine the essential clinical components (content items) and features (property-related items) for an acne global grading scale for use in research and clinical practice using an iterative method, the Delphi process. Methods Ten acne experts were invited to participate in a Web-based Delphi survey comprising 3 iterative rounds of questions. Results In round 1, the experts identified the following clinical components (primary acne lesions, number of lesions, extent, regional involvement, secondary lesions, and patient experiences) and features (clinimetric properties, ease of use, categorization of severity based on photographs or text, and acceptance by all stakeholders). In round 2, consensus for inclusion in the scale was established for primary lesions, number, sites, and extent; as well as clinimetric properties and ease of use. In round 3, consensus for inclusion was further established for categorization and acceptance. Patient experiences were excluded and no consensus was achieved for secondary lesions. Limitations The Delphi panel consisted solely of the United States (U.S.)–based acne experts. Conclusion Using an established method for achieving consensus, experts in acne vulgaris concluded that an ideal acne global grading scale would comprise the essential clinical components of primary acne lesions, their quantity, extent, and facial and extrafacial sites of involvement; with features of clinimetric properties, categorization, efficiency, and acceptance.

not available. Disclosures: Study sponsored by Aclaris Therapeutics. Copyright 2018 SKIN

Objective We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris. Methods A total of 2813 patients, aged 12 years or older, were randomized to receive clindamycin-BPO 2.5%, individual active ingredients, or vehicle in two identical, double-blind, controlled 12-week, 4-arm studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Score and subject self-assessment. Results Clindamycin-BPO 2.5% demonstrated statistical superiority to individual active ingredients and vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Visibly greater improvement was observed by patients with clindamycin-BPO 2.5% as early as week 2. No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events. Limitations Data from controlled studies may differ from clinical practice. Conclusions Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.

Seborrheic keratosis (SK) is among the most common cutaneous lesions, affecting some 83 million Americans. Biologically benign, SK lesions do not require removal for medical reasons unless histologic confirmation of the clinical diagnosis is required or the lesions are traumatized and/or become symptomatic. These macular or popular pigmented lesions are often of cosmetic concern to patients. In addition, their natural history of gradually increasing in size, thickness, and/or pigmentation often serves as the impetus compelling patients to present to a dermatologist for evaluation and skin cancer screening; SK is diagnosed and managed primarily by dermatologists. Data regarding SK prevalence and management from a survey of 594 practicing, board-certified dermatologists are summarized herein: Dermatologists report they diagnose an average of 155 patients per month with SK. Among SK patients presenting to dermatologists, 33% have more than 15 SK lesions and 67% have 15 or fewer SK lesions. On average, dermatologists treat 43% of their SK patients to remove lesions. Cryosurgery is the most common removal method. Other commonly employed removal methods include shave excision, electrodessication, curettage or a combination of these. While these procedures can be used to remove SK lesions effectively, each has potential drawbacks and careful patient selection is required to optimize cosmetic results particularly in skin of color patients and patients with thick or numerous lesions. While there is great interest from both patients and providers in a topical non-invasive treatment for SK, no effective topical therapeutic agent has been developed, and this remains an area of unmet need.

Objective The combination of erythromycin and benzoyl peroxide has proven to be a well-tolerated and effective topical treatment for acne vulgaris. A novel 3% erythromycin/5% benzoyl peroxide formulation provides a single unit-dose of erythromycin and benzoyl peroxide from a dual-pouch package and eliminates the need for pharmacist compounding and refrigeration. This study assessed the tolerability and efficacy of this formulation in patients with acne vulgaris.

Not Available

Background: Before the September 1996 approval of 1% penciclovir cream for the treatment of herpes labialis, no other prescription topical therapy was approved for the treatment of this recurrent viral disease affecting approximately 20% of the adult population of the United States. Local anesthetics, such as tetracaine, have been used in over-the-counter topical products, but are only labeled for the relief of pain and itching associated with cold sores and fever blisters. Objective: The purpose of this study was to determine whether a topical preparation of a tetracaine cream is safe and effective in the treatment of recurrent herpes labialis in immunocompetent patients. Methods: A double-blind, placebo-controlled study was conducted to assess the relative effectiveness and safety of 1.8% tetracaine equivalent in a cream base versus placebo in the treatment of herpes labialis in immunocompetent adults. In this study, patients applied medication up to 6 times daily until the lesions healed (scab loss), but for no more than 12 days. The patients were monitored on the day of enrollment, once during the course of treatment, and at a final visit after the lesions had healed. Patients assessed themselves the day of scab formation and the day the scab fell off. They also graded, on a daily basis, their perception of relief from itching and pain and the overall benefit. Results: The results from 72 patients (35 = placebo; 37=active) showed that scab formation occurred in a mean of 2.4 ± 0.27 days for the placebo group and 2.3 ± 0.26 days for the active group. Healing time (scab loss) occurred in a mean 7.2 ± 0.36 days for the placebo group and in 5.1 ± 0.35 days in the active group. The difference observed for healing time between the placebo and the active tetracaine cream was statistically significant (P = .0002). This represents an approximately 30% reduction in the healing time for the active group compared with the placebo group. In addition, the study patients ranked the benefit of their treatment on a daily basis and graded the overall benefit of the therapy at their final visit. The ranking was on a 1 to 10 index scale (1 = no benefit at all; 10=very effective treatment). At the final visit there was a statistically significant difference in the benefit index for active preparation versus placebo for this subjective evaluation (placebo index, 5.9 ± 0.6; active index, 7.3 ± 0.48 [P = .0359]). The subjects also evaluated relief from itching and pain on a daily basis. Relief from itching was significantly greater in the active group than in the placebo group on days 2 and 3 after initiation of the treatment. Pain was not found to be severe in either the placebo or active treatment groups. At day 2 of treatment and beyond, pain scores never were greater than 3.2 ± 0.28 for active on a scale in which 1.0 represented "no pain at all" and 10 represented "most severe pain imaginable." Although mean values for pain were always less for the active therapy, lesional pain scores never reached statistically significant lower values for active compared with placebo. Conclusion: Our findings indicate that a 1.8% topical tetracaine cream, when applied frequently, significantly reduces the healing time of recurrent herpes labialis lesions. Additionally, it is perceived by the study subjects to reduce itching of the lesions and to have a beneficial overall effect. (J Am Acad Dermatol 1999;41:996-1001.)

The etiopathogenesis of acne vulgaris, a common disorder of youth and adolescence, includes four primary processes: hyperkeratinization (plugging) of the pilosebacous follicles, increased testosterone levels, bacterial colonization with Propionibacterium acnes, and inflammation. No single agent has yet been developed that addresses all of these factors. Combination regimens, therefore, which usually include an antibiotic and an agent to reduce follicular plugging, have become the mainstay of treatment. Despite a relative dearth of new treatments for almost a decade, recent research has produced a number of new significant oral and topical agents. Azelaic acid, a naturally occurring dicarboxylic acid analogue, has shown promise, and a group of retinoids that include adapalene, tazarotene, and reformulations of tretinoin represent new and forthcoming agents for topical treatment of acne vulgaris. Some studies indicate that several of these agents are associated with less skin irritation than previous formulations while they retain potent comedolytic activity. Adapalene also possesses significant anti-inflammatory activity.

Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray 0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target lesion with an area of at least 5 cm(2) that achieved a combined score TLSS of=7, with a plaque elevation score of=3 (at least moderate). The mean % BSA affected by psoriasis ranged from 13%-17% at baseline. In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily. Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.

Acne therapy should be based on pathogenesis. Current mainstays of therapy include topical retinoids, antibiotics, and benzoyl peroxide. Newer research has shown that inflammation may precede comedo formation. Gene array analysis of acne lesions has elucidated newer inflammatory mediators that may become future targets for therapeutic development.

Background: Adapalene is a new synthetic retinoid analogue developed for the topical treatment of acne vulgaris. Objective: The study was designed to compare the efficacy and safety of adapalene gel 0.1% with tretinoin gel 0.025% in the treatment of grade II to III facial acne vulgaris. Methods: Three hundred twenty-three patients were enrolled in this investigator-masked, randomized, parallel group, multicenter trial. Patients applied the test materials to the entire facial area daily, for a period of 12 weeks. Efficacy and cutaneous tolerance were assessed at baseline and weeks 2, 4, 8, and 12. Efficacy was determined by investigator counts of non-inflammatory open and closed comedones, and inflammatory papules and pustules, as well as global improvement. Cutaneous tolerance was evaluated by erythema, scaling, and dryness, along with burning and pruritus. Results: Starting at weeks 2 and 4, adapalene gel produced numerically greater lesion reductions than did tretinoin gel for all lesion types. At week 12, the mean percent reduction in the different lesion counts was as follows: 49% versus 37% for total lesions ( p p = 0.02); 48% versus 38% for inflammatory lesions ( p = 0.06) in adapalene and tretinoin gel treatment groups, respectively. Cutaneous side effects were limited to a mild "retinoid dermatitis" occurring in both treatment groups; however, patients treated with adapalene gel tolerated this therapy significantly better than those treated with tretinoin gel. Laboratory test evaluations (hematology, blood chemistries, urinalysis) were performed in 54 patients before and after 3 months of treatment. No clinically significant changes were observed. Conclusion: Adapalene gel 0.1% applied once daily was significantly more effective in reducing acne lesions and was better tolerated than tretinoin gel 0.025% in the treatment of acne vulgaris.

Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population. Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol to manage moderate-to-severe disease over time.To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate 0.05% spray for up to four weeks followed by calcitriol 3 μg/g ointment for eight weeks in the management of moderate-to-severe plaque psoriasis.This was a multi-center, open-label study in subjects aged 18-80 years with moderate-to-severe plaque psoriasis at baseline. Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject's overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 μg/g ointment twice daily. Twice-daily treatment with calcitriol 3 μg/g ointment continued for eight weeks (until week 12) or unless the subject's ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated at baseline and at weeks 2, 4, 8 and 12.Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12 compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1 percent at baseline to 3.9 percent at week 12 (P0.001). The sequential treatment regimen was well tolerated with no unexpected adverse events. Most reported adverse events and cutaneous irritations were mild in severity.The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis.

Antimalarial medications are effective for the treatment of a variety of dermatologic conditions. Their use is often curtailed by concern for adverse reactions, including ophthalmologic side effects; however, recent evidence points to a greater margin of safety with these medications than was previously appreciated. This article reviews the pharmacology of antimalarial medications as well as indications and safe guidelines for their use in the treatment of dermatologic conditions.

Topical tretinoin is an effective therapy for the treatment of photodamaged skin. Clinically, patients experience decreased wrinkling, improved texture, and pinkening of sallow skin. However, the changes induced by topical tretinoin extend beyond simple cosmesis. Microscopic, ultrastructural, and biochemical alterations indicate that topical tretinoin is a significant medical therapy. Its successful use requires the guidance of an experienced physician.

The efficacy and safety of adapalene 0.1% gel in the treatment of acne vulgaris has been demonstrated in multiple controlled clinical trials. A higher concentration formulation, adapalene 0.3% gel, has been developed to provide a broader range of treatment options for acne management. Phase 3 clinical studies have demonstrated the superior efficacy of adapalene 0.3% gel compared to adapalene 0.1% gel and its vehicle at the end of a 12-week treatment period. The goal of this study was to evaluate the long-term safety of adapalene 0.3% gel in subjects treated once daily for 52 weeks, with a secondary objective to evaluate long-term efficacy. Subjects 12 years of age or older (N=551) with acne vulgaris participated in a multicenter, open-label study of the long-term (up to 52 weeks) efficacy and safety of once-daily applications of adapalene 0.3% gel. Of those enrolled, 167 subjects completed 12 months of treatment. Expected signs and symptoms of local cutaneous irritation (erythema, dryness, scaling, and stinging/burning) were mostly mild or moderate, with mean tolerability scores below 1 (mild) at all time points for the parameters assessed. Treatment-related, dermatologic adverse events were experienced by 21% of subjects and dry skin, skin discomfort, and scaling were reported by 10.5%, 8.3% and 3.3% of subjects, respectively. Most of the adverse events reported occurred in the first quarter of treatment. Adverse events were mostly mild to moderate in severity. Subjects treated with adapalene 0.3% gel for 52 weeks achieved a75% median reduction in total, inflammatory, and noninflammatory lesions in this open-label study by the end of the treatment period. Adapalene 0.3% gel was safe and effective in the long-term (up to 1 year) treatment of subjects with acne vulgaris.

Although topical applications of retinoids on rodents and humans have been shown to cause epidermal hyperplasia, a detailed study of the influence of retinoids on epidermal differentiation in vivo has not been performed. In order to assess the pharmacologic effects of chronic topical tretinoin application used to improve the appearance of patients with photoaged skin, cutaneous biopsies from 25 patients in a controlled clinical study were examined histologically and immunocytochemically. Chronic application of tretinoin causes epidermal thickening (25 of 25 samples), stratum granulosum thickening (15 of 25), parakeratosis (13 of 25), a marked increase in the number of cell layers expressing epidermal transglutaminase (13 of 25), and focal expression of two keratins, K6 (12 of 25) and K13 (8 of 25), not normally expressed in the epidermis. The morphologic changes correlated with immunohistochemical abnormalities; neither of these correlated with the subjective cosmetic response. Three major epidermal differentiation products, keratins K1, K10, and K14 were not altered, within the limits of the methods used. Thus, chronic topical tretinoin reprograms some, but not all, aspects of human epidermal differentiation in vivo.