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

ABSTRACT: 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.

SUBMITTER: Johnson AW

PROVIDER: S-EPMC4580655 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRosacea is a chronic inflammatory skin disorder that primarily affects the convexities of the central face. Depending on the severity and type of rosacea, physicians may prescribe interventions such as behavioral changes, laser and intense pulsed light, as well as various pharmacologic therapies, including topical agents. The impact of side effects associated with topical treatments for rosacea on patient preferences and treatment satisfaction is not well-documented.ObjectiveTo assess patients' concerns, treatment satisfaction, and quality of life (QOL) associated with topical treatments for rosacea.MethodsPatients were identified for participation in a one-time survey from electronic medical records between 2010 and 2015 from the largest privately held and physician-run multispecialty group practice in Massachusetts. Patients were eligible to participate in the survey if they were aged ≥18 years and had ≥1 diagnoses of rosacea, ≥1 prescriptions for topical metronidazole gel/cream or azelaic acid gel, ≥6 months of follow-up, and an active treatment record in 2014. Treatment-related concerns and their importance were assessed using a questionnaire developed for this study. Treatment satisfaction and QOL were evaluated using the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) and the Dermatology Life Quality Index (DLQI), respectively.ResultsOf the 900 eligible patients surveyed, 216 (24%) responded. Among the responders, 122 reported currently using a topical rosacea treatment. The most common treatment-related concerns were efficacy (64.8%), skin dryness (18.4%), unspecified side effects (9.6%), burning sensation (8.8%), and application technique (8.0%). The treatment-related concerns that were assessed as most important by responders included efficacy (mean score 9.1, on a 10-point scale), soreness (7.6), itching (7.5), burning (7.4), and dryness (7.3). Averaged across all the responders, treatment satisfaction was rated as neutral (mean SATMED-Q score, 56.5), whereas the impact of rosacea on QOL was minimal (mean DLQI score, 2.7). Increasing dryness was significantly associated with worsening QOL, and trends toward significance were observed for increasing soreness, itching, and burning sensations.ConclusionsThe survey results suggest a need for novel topical therapies for patients with rosacea that have increased efficacy and tolerability, which may improve patient satisfaction and QOL.

Project description:BACKGROUND:Once-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments. OBJECTIVES:To evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed. METHODS:In two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ? 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose. RESULTS:Among 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ? 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ? 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P<0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant. CONCLUSIONS:Assessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ? 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity.

Project description:ImportanceAlcohol flushing syndrome (AFS, also known as Asian glow and Asian flush) affects 20% to 47% of East Asians and causes significant psychosocial distress. There are no approved treatments for this condition.ObjectiveTo determine whether brimonidine gel, 0.33%, decreases facial erythema in patients with AFS after consumption of alcohol.Design, setting, and participantsIn this randomized clinical trial, 20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019.InterventionsParticipants were randomized to application of brimonidine gel to either the left or right half of their face. Placebo control was applied to the opposite side. After 30 minutes, participants ingested alcohol.Main outcomes and measuresOutcomes were specified before data collection. The difference in erythema between the treated and placebo side of each participant's face was measured 60 minutes after drug application (primary outcome) and at 90 and 120 minutes after drug application (secondary outcomes). Participants were asked to rate their likelihood of using the medication again and their likelihood of recommending the medication to a friend on a scale of 0 to 10.ResultsThe mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50%). There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001). This effect persisted at 90 and 120 minutes. Individuals were likely to use the medication again (7.2; 95% CI, 6.0-8.3) and would also recommend it to a friend (7.6; 95% CI, 6.5-8.6).Conclusions and relevanceThis study demonstrates that brimonidine gel is effective in reducing the facial erythema of AFS. Patients with psychosocial distress due to AFS may benefit from treatment with brimonidine.Trial registrationClinicalTrials.gov identifier: NCT03497442.

Project description:Introduction:Rosacea is a chronic multifactorial skin disorder mainly affecting facial skin with an estimated prevalence of about 5% worldwide. Its main symptoms, occurring early during pathology development, are skin dehydration, redness, erythema, and telangiectasia. Given the lack of a resolutive cure, therapeutic approaches able to relieve the main symptoms are needed. Purpose:The aim of this research article is to evaluate the beneficial effect of a topical product (Serum BK46) on rosacea symptoms. Patients and Methods:A monocentric single-arm, non-blinded study was performed to assess the clinical effect of Serum BK46 in relieving the main symptoms of rosacea: skin dryness, increased trans epidermal water loss (TEWL), redness, and abnormal vascularization. Twenty patients with mild to moderate rosacea were enrolled in the study and asked to apply the product twice per day for 56 days. Skin moisturization, TEWL, and erythema index were instrumentally assessed at baseline and following 24 h and 14, 28 and 56 days of treatment. Clinical parameters, including redness and telangiectasia imperfection visibility, were evaluated on a 5-point scale by a specialized dermatologist at baseline and after 14, 28, and 56 days of treatment. Finally, the visibility of vessel diameter was evaluated at baseline and after 28 and 56 days of treatment. Results:Serum BK46 application restored skin hydration and prevented the loss of water by the skin. Long-term treatment with Serum BK46 significantly reduced skin redness, erythema index, and the visibility of telangiectasia imperfections and superficial vessels. The investigated product's clinical effect was demonstrated by both instrumental and clinical evaluation. Furthermore, Serum BK46 was completely tolerated and no adverse effects were recorded. Conclusion:The moisturizing and skin barrier restoring action of Serum BK46 has been clearly proven in patients displaying mild to moderate rosacea; thus, this product is a good candidate for rosacea treatment.

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

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