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Topical Oxymetazoline Hydrochloride Cream 1% for the Treatment of Persistent Facial Erythema of Rosacea in Adults: A Comprehensive Review of Current Evidence.

ABSTRACT: BACKGROUND: Rosacea is a chronic, multisymptom, inflammatory condition that affects the centrofacial skin. Facial erythema associated with rosacea can negatively impact a patient's quality of life and is often hard to treat. OBJECTIVE: We sought to review the literature on the role of alpha-adrenergic receptors (α-adrenoceptors) in the context of persistent facial erythema in patients with rosacea and the use of oxymetazoline hydrochloride cream 1% as a topical treatment. METHODS: PubMed was searched; search terms included "alpha adrenoceptor," "oxymetazoline," and "rosacea." Additional articles were identified from the reference lists of the results. RESULTS: Some α-adrenoceptor agonists have vasoconstrictive properties and may be used topically to treat persistent facial erythema in rosacea. Oxymetazoline hydrochloride cream 1% is an α_1A-adrenoceptor agonist approved for the treatment of persistent facial erythema associated with rosacea. Based on our review, we discuss the role of the α-adrenoceptor in persistent facial erythema; provide an overview of the mechanism of action of α-adrenoceptor agonists, such as oxymetazoline, in the treatment of persistent facial erythema; and summarize the clinical development and data to date demonstrating the efficacy and safety of oxymetazoline in the treatment of persistent facial erythema associated with rosacea. CONCLUSION: The review of available literature suggests that oxymetazoline cream is well-tolerated, safe, and effective for the treatment of persistent facial erythema in rosacea and is an important component of combination treatment regimens, which are likely to become the standard of treatment for rosacea in the future.

SUBMITTER: Del Rosso JQ

PROVIDER: S-EPMC8021401 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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:ImportanceAcne is a common, multifactorial skin condition, and treatments with novel mechanisms have been elusive.ObjectiveTo assess the safety and efficacy of clascoterone cream, 1%, a novel topical androgen receptor inhibitor, in 2 phase 3 randomized clinical trials (CB-03-01/25 and CB-03-01/26).Design, setting, and participantsTwo identical, multicenter, randomized, vehicle-controlled, double-blind, phase 3 studies conducted from November 2015 to April 2018 evaluated the efficacy and safety of use of clascoterone cream, 1%, in males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale. Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammatory lesions.InterventionsPatients were randomized to treatment with clascoterone cream, 1%, or vehicle cream and applied approximately 1 g to the whole face twice daily for 12 weeks.Main outcomes and measuresTreatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts at week 12. Safety measures included adverse event frequency and severity.ResultsA total of 1440 patients were randomzied in 2 studies. In CB-03-01/25, 353 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-58] years; 221 [62.6%] female), and 355 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [9-50] years; 215 (60.6%) female); in CB-03-01/26, 369 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-50] years; 243 [65.9%] female), and 363 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [range, 11-42] years; 221 [60.9%] female). At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively. At week 12, in both CB-03-01/25 and CB-03-01/26, treatment with clascoterone cream, 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to -19.4 (point estimate difference, -6.4; 95% CI, -10.3 to -2.6; P < .001) and -19.4 (point estimate difference, -8.6; 95% CI, -12.3 to -4.9; P < .001) vs -13.0 and -10.8 with vehicle, respectively, as well as a reduction in inflammatory lesions from baseline to -19.3 (point estimate difference, -3.8; 95% CI, -6.4 to -1.3; P < .001) and -20.0 (point estimate difference, -7.4; 95% CI, -9.8 to -5.1; P < .001) vs -15.5 and -12.6 with vehicle, respectively. Adverse events rates were low and mostly mild; the predominant local skin reaction was trace or mild erythema.Conclusions and relevanceUse of clascoterone cream, 1%, for acne treatment appears to demonstrate favorable efficacy and safety with low adverse event rates.Trial registrationClinicalTrials.gov Identifiers: NCT02608450 and NCT02608476.

Project description:BackgroundRosacea is a common chronic skin condition that manifests as recurrent inflammatory lesions. Long-term treatment is required to control symptoms and disease progression, with topical treatments being the first-line choice. Ivermectin 1 % cream is a new once-daily (QD) topical treatment for the inflammatory lesions of rosacea, and it is important to compare the efficacy, safety, and tolerability of ivermectin with other currently available topical treatments.MethodsA systematic literature review was performed from January 2011 to June 2015, with articles published prior to 2011 retrieved from a Cochrane review on rosacea. Randomized controlled trials of the topical treatment of adult patients with moderate-to-severe papulopustular rosacea were identified from electronic databases and trial registers, and supplemented with data from clinical study reports. Mixed treatment comparisons (MTCs) were conducted to compare different treatments according to Bayesian methodology.Results57 studies were identified, with 19 providing data suitable for MTC. Ivermectin 1 % cream QD led to a significantly greater likelihood of success compared with azelaic acid 15 % gel twice-daily (BID) [relative risk (95 % credible interval): 1.25 (1.14-1.37)], and metronidazole 0.75 % cream BID [1.17 (1.08-1.29)] at 12 weeks. Ivermectin 1 % cream QD also demonstrated a significant reduction in inflammatory lesion count compared with azelaic acid 15 % gel BID [-8.04 (-12.69 to -3.43)] and metronidazole 0.75 % cream BID [-9.92 (-13.58 to -6.35)] at 12 weeks. Ivermectin 1 % cream QD led to a significantly lower risk of developing any AE or TRAE compared with azelaic acid 15 % gel BID [0.83 (0.71-0.97) and 0.47 (0.32-0.67), respectively].ConclusionsIvermectin 1 % cream QD appears to be a more effective topical treatment than other current options for the inflammatory lesions of rosacea, with at least an equivalent safety and tolerability profile, and could provide physicians and dermatologists with an alternative first-line treatment option.

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Topical Oxymetazoline Hydrochloride Cream 1% for the Treatment of Persistent Facial Erythema of Rosacea in Adults: A Comprehensive Review of Current Evidence.

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