Topical Oxymetazoline Research Articles

Even Patients Who Respond Poorly to the Phenylephrine Test Can Benefit From Topical Oxymetazoline for Temporary Eyelid Ptosis Management.

Even Patients Who Respond Poorly to the Phenylephrine Test Can Benefit From Topical Oxymetazoline for Temporary Eyelid Ptosis Management.

The Use of Oxymetazoline 0.1% Ophthalmic Solution for Acquired Blepharoptosis: A Systematic Review.

Oxymetazoline hydrochloride has been shown to be effective in some studies for acquired blepharoptosis and for aesthetic upper eyelid elevation. This study aims to systematically review the literature on the use of topical oxymetazoline for treating acquired blepharoptosis. PubMed (U.S. National Library of Medicine, National Institutes of Health), Scopus (Elsevier), and Cochrane. A systematic review of studies published between 2013 and 2024 following PRISMA guidelines was performed using the PubMed, Scopus, and Cochrane databases. Primary outcomes included pre- to posttreatment change in marginal reflex distance (MRD1) after treatment with topical oxymetazoline, and mean difference (pre-to-posttreatment) in MRD1 versus control. Five articles included data from 458 patients for analysis. Meta-analysis demonstrated significant improvement in MRD1 measurements posttreatment with oxymetazoline (1.40 mm; 95% confidence interval, CI [0.41 mm, 2.40 mm]). In addition, when compared to controls, patients treated with oxymetazoline demonstrated greater increase in MRD1 values (0.83 mm; 95% CI [0.10 mm, 1.55 mmm]). Heterogeneity, measured by I2 statistic, was high in all studies (85%-95%). The use of oxymetazoline 0.1% ophthalmic solution significantly improves MRD1 in patients with acquired blepharoptosis. Further studies comparing this treatment in other etiologies of acquired blepharoptosis should be conducted. Laryngoscope, 2024.

What is the Best Management for Geriatric Epistaxis? A Comprehensive Systematic Review and Meta-analysis

Background: Given the importance of epistaxis in elder patients, this systematic review was conducted to determine the best non-surgical treatment of epistaxis in elder patients. Methods: A systematic search of references was performed to investigate non-surgical methods in administering epistaxis in elder people in March 2022 for relevant articles. Results: Among 1613 retrieved articles in the initial search, 28 studies were included, and the mean re-bleeding in 18 studies was 18%. Regarding the treatment methods, 35.7%, 14.3%, 10.7%, and 10.7% used nasal packing, intranasal topical tranexamic acid, silver nitrate, and Floseal® treatment, respectively. The highest success rate was related to topical tranexamic acid compared to topical oxymetazoline spray (Odds ratio [OR]: 6.50, 95% confidence interval [CI]: 1.54-27.49, P=0.011), followed by nasal compression with tranexamic acid compared to the placebo. Conclusion: It seems that tranexamic acid has a beneficial effect on controlling epistaxis in the elderly. However, well-designed large randomized controlled trials are indicated for an accurate conclusion.

Management of Severe Botulinum-Induced Eyelid Ptosis With Pre-tarsal Botulinum Toxin and Oxymetazoline Hydrochloride 0.1.

Eyelid ptosis following periocular onabotulinumtoxinA (BoNT-A) treatment is a known complication which can be frustrating for both patients and practitioners. Iatrogenic blepharoptosis occurs due to local spread of the BoNT-A from the periocular region into the levator palpebrae superioris muscle; while injectors should have a thorough understanding of the relevant anatomy in order to prevent it, BoNT-A induced ptosis can occur even in the most experienced hands. To describe a case series of patients effectively treated with Oxymetazoline HCl 0.1% and pre-tarsal BoNT-A injections in the setting of botox-induced ptosis. Eight patients were included who underwent recent cosmetic BoNT-A treatment preceding the sudden onset of unilateral upper eyelid ptosis. A diagnosis of severe ptosis (>3 mm) was made in all the cases in this series. Pre-tarsal BoNT-A injections alone or in association with topical administration of Upneeq eyedrops (Upneeq, Osmotica Pharmaceuticals, Marietta, GA) significantly reversed the ptosis in all treated cases. This is the first documented case series of patients effectively treated with Oxymetazoline HCl 0.1% and pre-tarsal BoNT-A injections in the setting of botox-induced ptosis. This treatment combination is a safe and effective option in these cases.

The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial

PurposeThis study assesses the effects of topical oxymetazoline 0.1% on eyelid position, eye redness, and patient-perceived eye appearance in patients without severe ptosis. MethodsThis is a randomized double-blinded controlled trial conducted at a single institute. Patients aged 18–100 years were randomized to receive one drop of oxymetazoline hydrochloride 0.1% or placebo bilaterally. Marginal reflex distance (MRD) 1 and 2, palpebral fissure height, eye redness, and patient-perceived eye appearance were assessed at baseline and two hours after drop instillation. Primary outcome measures included the change in MRD1, MRD2, and palpebral fissure height. Secondary outcome measures included changes in eye redness and patient-perceived eye appearance after drop instillation. ResultsIn total, 114 patients were included, 57 treatment patients (mean age 36.4 ± 12.7 years, 31.6% male) and 57 controls (mean age 31.3 ± 10.1 years, 33.3% male). Baseline mean MRD1, MRD2, and palpebral fissure were similar between groups (p = 0.24, 0.45, and 0.23, respectively). Changes in MRD1 and eye redness in the treatment group were significantly greater than those in the control group (0.9 ± 0.9 mm vs. − 0.3 ± 0.4 mm, p < 0.001; − 2.6 ± 4.4 vs. − 0.5 ± 2.3, p = 0.002, respectively). Patient-perceived eye appearance was significantly improved in the treatment group compared to the controls (p = 0.002), with more treatment group patients also reporting increased eye size and decreased eye redness (p = 0.008, p = 0.003, respectively). There were 9 treatment-emergent adverse events (TEAEs) in 7 treatment group patients and 5 TEAEs in 5 control patients (p = 0.25), all of which were mild in severity. ConclusionsTopical oxymetazoline 0.1% increases MRD1 and palpebral fissure height, decreases eye redness, and improves patient-perceived eye appearance.

Can oxymetazoline simulate the outcomes of septoplasty and inferior turbinate reduction surgery?

Inferior turbinate hypertrophy (ITH), with or without nasal septum deviation, is among the most common surgically correctable etiologies of nasal obstruction.1 The current challenge associated with surgical decision is twofold: 1) there are significant variabilities in individual nasal anamtomies as well as in surgical techniques; 2) there are few objective measures to identify which patients would benefit from surgery.2, 3 A patient's responsiveness to oxymetazoline has been often used as a proxy for surgical candidacy.3 Oxymetazoline is a selective α1 adrenergic receptor agonist and α2 adrenergic receptor partial agonist, which causes vasoconstriction and results in nasal decongestion since the soft tissue of the turbinates is rich in venous sinusoids and seromucinous glands. Yet despite the ubiquitous use of this bedside test, there are limited data that objectively compare the effect of oxymetazoline versus surgery on nasal morphology and aerodynamics, and whether such an approach could be used to predict patient outcomes. This study uses computational fluid dynamics (CFD) modeling to examine the changes in nasal aerodynamics and resistance in one patient after administration of oxymetazoline nasal spray as well as after inferior turbinate reduction surgery, to preliminarily investigate whether the changes in these factors are similar between the two and can corroborate the degree of symptomatic improvement. The patient is a 39-year-old male with moderate bilateral ITH and septal deviation resulting in nasal obstructive symptoms refractory to topical intranasal steroids. He denied history of chronic rhinosinusitis, allergies, head trauma, or autoimmune/connective tissue disorders. The patient completed the NOSE, SNOT-22, and Visual Analog Scales (VAS) for nasal obstruction (0: completely clear, 10: completely obstructed) immediately before his baseline computed tomography (CT) scan. To rule out placebo effect, a single-blinded sham test was performed with saline solution prior to oxymetazoline administration. Saline was topically applied via nasal spray followed by a 30 min rest and reassessment of symptoms (VAS and NOSE score). After the sham test, topical oxymetazoline spray was applied with symptom reassessment after a 30 min rest. A second CT scan then immediately followed. The patient ultimately underwent bilateral inferior turbinate reduction as well as minor septoplasty to remove a septal spur, with postoperative assessment after 8 weeks. Three-dimensional CFD models were constructed using the described method5 based on cone beam CT scans (3D Accuitomo 170, J. Morita USA, Inc.) at three time points: baseline, 30 min after oxymetazoline, and 8 weeks after surgery. Airflow patterns and velocity changes throughout the nasal airway were simulated under quasi-steady restful breathing conditions (15 Pa pressure drop between the nostrils and the nasal pharynx at a room air temperature of 20°C) using CFD software (ANSYS Fluent 19.2, Ansys, Inc, Canonsburg, PA). The numerical method and meshing protocol applied in this study have been previously validated against experimental measurements.4 The patient reported significant symptomatic improvement after both oxymetazoline and surgery. The NOSE score decreased from 80 at baseline and 80 after the sham test to 35 after oxymetazoline spray and 30 at 8 weeks after surgery. Likewise, VAS ratings of nasal obstruction decreased from 7 at baseline, to 6 after the sham test, 3 after oxymetazoline spray, and 2 after surgery. The SNOT-22 score decreased from 39 at baseline, to 9 at the post-surgery visit. Despite similar symptomatic outcomes, the aerodynamic effect of oxymetazoline was distinctly different and more pronounced than that of surgery. Post-oxymetazoline, nasal resistance was reduced by 56%, while average airflow velocity increased by 128% from baseline. Post-surgery, nasal resistance only reduced by 17%, while average airflow velocity increased by 21%. Peak mucosal heat flux increased 122% post-oxymetazoline versus 27% post-surgery as compared to baseline (Figure 1). Morphologically, oxymetazoline can affect the full length of inferior, middle, and superior turbinates, whereas the effect of surgery is limited to the surgical sites (Figure 2). The high velocity airflow is centered around the inferior portion of the middle turbinate post-oxymetazoline, while distributed towards the inferior turbinate post-surgery (Figure 2). One additional benefit of surgery may be the balancing of airflow between the two nasal cavities. At baseline, the patient's right nasal cavity had 4.55 times higher resistance than the left side. This reduced to 1.35 times after oxymetazoline administration and was nearly even (0.96) after surgery. This airflow-balancing effect may contribute to the marked improvement in airflow sensation post-surgery despite significantly better aerodynamic improvement post-oxymetazoline. This finding necessitates further study to confirm. Oxymetazoline and nasal airway surgery have comparable outcomes in relieving nasal obstructive symptoms. However, they appear to impact nasal morphology and aerodynamics very differently. Additional studies are warranted to rigorously test whether the responsiveness to oxymetazoline is a reliable predictor of satisfactory surgical outcomes. This study was supported by an investigator-initiated research grant by Bayer Health USA, Inc., to K.Z. The authors have no conflicts of interest to report.

Benefits and safety of Oxymetazoline cream 1% on rosacea-associated erythema: A systematic review and analysis of clinical evidence.

Facial persistent erythema is recognized as difficult feature to treat in rosacea. Topical Oxymetazoline cream 1% has been used to treat persistent facial erythema in rosacea patients for some years. To quantitatively synthesize the benefits and harms of Oxymetazoline cream 1% in real-world clinical management of treatment response and adverse events. The clinical researches before June 1, 2022 published on online databases including PubMed, Web of Science, Embase and Cochrane Library were meta-analyzed. A total of 2298 participants were included, and the improvement rate of two-grade Clinician Erythema Assessment score (CEA) and Subject Self-Assessment for rosacea facial redness score (SSA) in Oxymetazoline group was 38% (95%CI 28-48) and 25% (95%CI 22-27), respectively, at the 4th week of the dosing. The comprehensive rate of treatment-related TEAEs in Oxymetazoline group was 7% (95%CI 5-8). The rate of stinging/burning was 15% (95%CI 10-19), pruritus was 15% (95%CI 9-22), dryness was 23% (95%CI 18-28), and scaling was 17% (95%CI 12-22) in analysis of dermal tolerability. And topical Oxymetazoline cream 1.0% presented a very low rebound rate of erythema (1%, 95%CI 0-2). These real-world data on Oxymetazoline cream 1% in rosacea-associated erythema may help making clinic decision and informing treatment expectations, and more clinic trials on longer-term dosing or the combination treatment with oral medication and energy-based therapy are worth exploring.

Changes to Eye Whiteness and Eyelid/Brow Position With Topical Oxymetazoline in Aesthetic Patients.

Oxymetazoline hydrochloride 0.1% ophthalmic solution has recently been approved in the United States for the treatment of ptosis. The aim of this study was to assess the upper and lower eyelid position as well as the brow position and the color of the sclera following the ophthalmic administration of oxymetazoline hydrochloride 0.1%. In this prospective cohort study, consecutive patients presenting with ptosis received topical oxymetazoline 0.1%. The primary outcome was measurement of the upper eyelid height (margin-to-reflex distance 1 [MRD1]) and lower eyelid height (MRD2) relative to the center of pupil, along with assessment of brow height, measured on photographs at baseline and 2 hours after instillation of oxymetazoline. The secondary outcome was the assessment of the color of the sclera (eye whiteness) before and after treatment with a novel color space algorithm. Twenty-nine patients participated in the study. The mean [SD] MRD1 at baseline was 2.3 [0.6] mm. At 2 hours following oxymetazoline treatment, the mean MRD1 significantly increased to 4.2 [0.9] mm (P < 0.01). The mean MRD2 also significantly increased from 5.3 [0.9] mm to 5.7 [1.0] mm (P < 0.01). Brow position did not change with treatment (P = 0.4). Following treatment, the eye sclera became significantly whiter, with a mean ΔEab (color change) of 9.7 [3.9], with 57 out of 58 eyes experiencing a significant change in color. A change of ΔEab ≥2 is considered visually perceptible to the human eye. Within 2 hours of use, oxymetazoline significantly improves the size of the palpebral aperture (MRD1 + MRD2) and also makes the eye appear significantly whiter.

A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea.

Background and ObjectivesWe evaluated if oxymetazoline therapy combined with 595‐nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of erythematotelangiectatic rosacea.Study Design/Materials and MethodsThis was a randomized, controlled, prospective clinical trial approved by an independent Institutional Review Board, which enrolled 34 patients with moderate to severe clinical erythema (CEA) into a two‐arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients in Arm 1 were treated with 3 monthly laser sessions, which were started after 1 month of topical oxymetazoline cream. Thirty subjects continued with the study, and 25 subjects (Arm 1: 14, Arm 2: 11) completed the 6‐month follow‐up. With photographic comparison to baseline images, efficacy endpoints were based on clinical on‐site grading by both the investigator and the patient, using the grading tools for CEA, Global Aesthetic Improvement (GAI) assessment, vessel size improvement, and subject self‐assessment. These scales were assessed at baseline and/or at each clinical follow‐up at 1, 2, 3, and 6 months. Subject satisfaction as well as post‐treatment immediate response and treatment‐associated pain scores were also evaluated.ResultsStatistically significant improvement in CEA was seen in both arms at the 1‐, 2‐, and 3‐month post‐baseline visits (P < 0.01). Only Arm 1 presented statistically significant improvement in CEA (P < 0.001) at 6 months post baseline with a mean score of 1.6 (almost clear‐mild) compared with 3.2 at baseline. Arm 1 showed significantly greater mean vessel size improvement at 3 months (P < 0.01) and 6 months (P < 0.05) post baseline compared to Arm 2. Significantly greater improvement (P < 0.05) in the investigator GAI score was reported at the 2‐ and 6‐month follow‐ups compared with Arm 2. Subject GAI scores showed statistically significant greater improvement in Arm 1 compared with Arm 2 at both the 3‐ and 6‐month follow‐ups (P < 0.01). There were no complications or long‐term effects associated with PDL or topical oxymetazoline treatments.ConclusionThe prospective trial verifies a safe, enhanced clinical outcome with the combination of PDL therapy and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea patients. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

16668 Pulsed dye laser is more cost-effective than topical brimonidine and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea: A systematic review of the literature and meta-analysis

We performed a cost-analysis comparing pulsed dye laser (PDL), topical brimonidine, and topical oxymetazoline for treatment of erythematotelangiectatic rosacea (ETR). For the topicals, we calculated the number needed to treat to achieve a two-grade Clinician Erythema Assessment (CEA) improvement. For PDL, physician-reported 50% erythema improvement was used as CEA was not frequently assessed in PDL studies. For the topicals, data was obtained from their phase III trials. For PDL, we performed a meta-analysis of prospective studies evaluating PDL for ETR identified through systematic literature review. Six studies containing 93 patients were analyzed as they reported the outcome of interest. To assess cost, we used the lowest price for the topicals listed on goodrx.com and our institutional PDL cost. In the topical brimonidine and oxymetazoline trials, 55% and 40.1% achieved a two-grade improvement in CEA respectively. In our PDL meta-analysis, 60.2% (56/93) achieved a 50% reduction in physician-reported erythema. PDL patients required an average of 2.96 treatments. Based on the average length of PDL follow-up (14.3 weeks), cost to achieve our outcome of interest was $2159.47 for PDL, $2923.77 for topical brimonidine, and $4567.72 for topical oxymetazoline. This suggests PDL is the most cost-effective modality for treating ETR. Our study likely overestimated PDL cost as PDL likely creates durable improvement beyond the 14.3-week cost-analysis period; whereas, topicals require continued daily application to maintain benefit. Limitations of our study include use of a surrogate outcome to compare efficacy and heterogeneity and poor quality of the PDL studies (eg, no control groups).

Epistaxis

Key Points Anterior acute bleeding from the nostril or nasal cavity accounts for greater than 90% of epistaxis in children. Posterior bleeding into the nasopharynx and mouth is more difficult to assess and likelier to lead to hemodynamic instability. Up to one-third of children with recurrent bleeding have a coagulopathy. Direct pressure via pinching the nostrils for 5 to 10 minutes is the first-line treatment. Topical lidocaine, silver nitrate sticks, topical oxymetazoline, anterior packing, and other vasoconstrictive and hemostatic tactics may be used. Posterior epistaxes require referral to an otolaryngologist because they are more difficult to control.

Topical Oxymetazoline (Rhofade) in Rosacea

ABSTRACT By definition, a drug is a medicine or substance that exerts a physiologic effect on an organism. In dermatology, various medications and substances are utilized on a daily basis, ranging from topical treatments to anesthetics in micrographic surgery. The purpose of this section is to focus on some of the more common substances, specifically how they work, how they are utilized, and routine alternatives (if available). The mechanism of action, usage, and alternative options of the medication topical oxymetazoline are discussed.

Successful treatment of the face post acne erythema using a topically applied selective alpha 1-Adrenergic receptor agonist, oxymetazoline 1.5%, a controlled left to right face comparative trial

Background Post-inflammatory erythema (PIE) is a common sequalae of acne inflammation, persistent post acne erythema (PAE) is cosmetically unacceptable and sometimes its complete clearance could not be achieved. Oxymetazoline (OXZ) is a synthetic, direct-acting, sympathomimetic agonist that is highly selective for the 1α-adrenoceptor. It is a potent vasoconstrictor and well known for its ability to clinically ‘get the red out’. Aim The aim of this study was to evaluate the efficacy and safety of topical oxymetazoline (OXZ) 1.5% in treatment of post acne erythema (PAE) in a left to right face comparative study. Methods This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control. Results According to the investigator’s global assessment of photographs and the analysis of erythema with image analysis software, topical OXZ was significantly effective in diminishing PAE when compared to topical placebo lipogel Conclusion Topical OXZ is a safe and effective treatment for post-acne erythema.

Rosacea treatment guideline for The Netherlands

The authors of this research letter developed a treatment guideline for patients with rosacea in The Netherlands, based on a recently published review of all evidence on treating rosacea. The Dutch Society of Dermatology and Venereology funded the project and provided two staff members who supported the working group (WG). The WG consisted further of four dermatologists, a general practitioner, an ophthalmologist, a plastic surgeon, two skin therapists and a patient. For the process the most rigorous methodological standards were used. Ten health questions were covered in the guideline which assessed a range of self-care measures and treatment options, considering effectiveness and safety. Recommendations for these health questions were made by combining the evidence with values and preferences of patients, costs and availability. Recommendations are either strong (‘recommend’) or weak (‘consider’), and for or against a treatment. The authors presented the relevant treatments in an algorithm (Fig 1). Not mentioned are topical oxymetazoline for persistent redness (not available in The Netherlands) and those treatments with recommendations against. Considering rosacea has a negative impact on quality of life, a full chapter was dedicated to this in the guideline. In this chapter the authors recommended that doctors address quality of life, treatment satisfaction, social and professional functioning, and psychological well-being, in order to optimise treatment. In addition, a comprehensive patient information leaflet was made available on rosacea, its treatment and self-care. Figure 1Open in figure viewerPowerPoint Rosacea treatment algorithm. Consider = weak recommendation, Recommended = strong recommendation, b.i.d. = twice daily, q.d. = once daily. Erythema = redness. Papules = pimples. Pustules = pus-filled spots. Phyma = thickened nose. Telangiectasia= visible small blood vessels. This is a summary of the study: Rosacea treatment guideline for the Netherlands

Interventions for rosacea based on the phenotype approach: an updated systematic review including GRADE assessments.

SummaryBackgroundRosacea is a common chronic facial dermatosis. Classification of rosacea has evolved from subtyping to phenotyping.ObjectivesTo update our systematic review on interventions for rosacea.MethodsWe searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index and ongoing trials registers (March 2018) for randomized controlled trials. Study selection, data extraction, risk‐of‐bias assessment and analyses were carried out independently by two authors. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to assess certainty of evidence.ResultsWe included 152 studies (46 were new), comprising 20 944 participants. Topical interventions included brimonidine, oxymetazoline, metronidazole, azelaic acid, ivermectin and other topical treatments. Systemic interventions included oral antibiotics, combinations with topical treatments or other systemic treatments. Several studies evaluated laser or light‐based treatment. We present the most current evidence for rosacea management based on a phenotype‐led approach.ConclusionsFor reducing temporarily persistent erythema there was high‐certainty evidence for topical brimonidine and moderate certainty for topical oxymetazoline; for erythema and mainly telangiectasia there was low‐to‐moderate‐certainty evidence for laser and intense pulsed light therapy. For reducing papules/pustules there was high‐certainty evidence for topical azelaic acid and topical ivermectin; moderate‐to‐high‐certainty evidence for doxycycline 40 mg modified release (MR) and isotretinoin; and moderate‐certainty evidence for topical metronidazole, and topical minocycline and oral minocycline being equally effective as doxycycline 40 mg MR. There was low‐certainty evidence for tetracycline and low‐dose minocycline. For ocular rosacea, there was moderate‐certainty evidence that oral omega‐3 fatty acids were effective and low‐certainty evidence for ciclosporin ophthalmic emulsion and doxycycline.

Topical Oxymetazoline for Fecal Incontinence in Patients with Spinal Cord Injury: A Double-Blind Randomized Controlled Crossover Study

Topical α-agonists contract the internal anal sphincter muscle; therefore, they may serve as treatment for fecal incontinence. The aim of this study was to investigate the effect of the α-agonist oxymetazoline 1.0% on fecal incontinence in patients with spinal cord injury. This was a double-blind, crossover study. Before randomization, all patients underwent a 1-day, open-label anal manometry and pharmacokinetic study. The study was conducted at the Department of Internal Medicine, Semmelweis University, Hungary. Nineteen patients were enrolled into a randomized double-blind, placebo-controlled clinical trial with 2 arms: placebo for 4 weeks followed by oxymetazoline for 4 weeks, or vice versa, with an interval 2-week washout period, in a crossover trial design. Treatment order was randomly assigned, and fecal incontinence was captured with daily diaries. The primary outcome measured was the number of fecal incontinence episodes in the 8 and 12 hours after drug administration. Resting anal pressure increased in response to oxymetzoline (25.2%). The change in the mean fecal incontinence episodes per month (12 hours post drug application) favored oxymetazoline over placebo: 26.3 (SD ±28.4) versus 36 (SD ±39.8) (p = 0.021). When only nongas episodes were included, the mean number of episodes decreased from 10.1 (+4.3) to 6.3 (±2.1) fecal incontinence episodes per month (p = 0.022). No difference was observed in adverse events between treatment and placebo periods. All pharmacokinetic samples were below the detection limit. The study was limited by the small number of participants. In this study, oxymetazoline gel presented a clear clinical beneficial effect accompanied by a favorable safety and tolerability profile. Results of the pharmacokinetic analysis indicate that the clinical benefit was mainly due to a local effect of oxymetazoline. Future studies are planned to investigate higher doses of oxymetazoline for this indication. See Video Abstract at http://links.lww.com/DCR/A797.

Oxymetazoline: reduction of subconjunctival hemorrhage incidence after intravitreal injections

Subconjunctival hemorrhage (SCH) is an important minor side effect that might affect patient compliance to antivascular endothelial growth factor (anti-VEGF) intravitreal injection treatment (IVI). We sought to compare SCH incidence and pain score responses after topical oxymetazoline in naïve patients undergoing a single IVI of ranibizumab for diabetic macular edema. Prospective, randomized, double-blinded, single centre study. One hundred two patients naïve to anti-VEGF were assigned to receive either topical oxymetazoline or placebo 30 minutes before IVI. SCH incidence and area were measured by slit lamp 24 hours after, and pain was evaluated 5 minutes and 24 hours after. SCH incidence was reported on 72% in control group versus 51% in oxymetazoline group (p = 0.037). Mean size of SCH was 16.82 mm2 in control group versus 12.55 mm2 in oxymetazoline group (p = 0.394). Prevalence of local pain in the overall study population was 60%. No significant statistical difference was achieved between groups 5 minutes or 24 hours after IVI in either pain scale evaluation. Administration of topical oxymetazoline 30 minutes before IVI is a single, harmless, cost-effective intervention that decreases the incidence of subconjunctival hemorrhage. This may considerably improve patient treatment satisfaction and promote compliance to IVI therapy.

Long-term topical oxymetazoline hydrochloride 1.0% demonstrates sustained and increasing effect in persistent facial erythema of rosacea

Long-term topical oxymetazoline hydrochloride 1.0% demonstrates sustained and increasing effect in persistent facial erythema of rosacea

WITHDRAWN: Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials

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Role of Topical Oxymetazoline for Management of Erythematotelangiectatic Rosacea

To review and summarize topical oxymetazoline's pharmacology, pharmacokinetics, efficacy, safety, cost, and place in therapy for persistent redness associated with erythematotelangiectatic rosacea. Literature searches of MEDLINE (1975 to September 2017), International Pharmaceutical Abstracts (1975 to September 2017), and Cochrane Database (publications through September 2017) using the terms rosacea, persistent redness, α -agonist, and oxymetazoline. Results were limited to studies of human subjects, English-language publications, and topical use of oxymetazoline. Relevant materials from government sources, industry, and reviews were also included. Data support the efficacy of oxymetazoline for persistent facial redness. Little study beyond clinical trials cited in the drug approval process has been conducted. Current data suggest that oxymetazoline is similar in safety and efficacy to brimonidine. Head-to-head comparisons of topical α-agonists for erythema caused by rosacea are needed. The topical α-agonist, oxymetazoline, is safe and effective for reducing persistent facial redness associated with erythematotelangiectatic subtype of rosacea. Health care practitioners selecting among treatments should consider not only the subtype of rosacea but also individual patient response, preference, and cost.