A review of nonsurgical facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1% in periorbital revitalization.

BACKGROUND: The demand for nonsurgical facial rejuvenation options is growing, yet the periorbital region remains an area of relative unmet need. This review explores nonsurgical options for facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating age-related blepharoptosis as part of periorbital rejuvenation. METHODS: Advisors experienced in facial rejuvenation met to discuss existing literature on the upper face and periorbital rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating facial aging. RESULTS: An array of nonsurgical options exist to address the signs of aging, including minimally invasive treatments, such as botulinum toxin injections and dermal fillers, and noninvasive therapy, such as lasers, chemical peels, and microdermabrasion. However, treating age-related ptosis in periorbital rejuvenation is mainly addressed surgically. The newly approved α-adrenergic receptor agonist oxymetazoline hydrochloride ophthalmic solution, 0.1%, provides a novel non-interventional approach to blepharoptosis. CONCLUSIONS: Facial rejuvenation is highly sought-after in this post-pandemic era. Each nonsurgical treatment option has its advantages and drawbacks. A patient-centered approach is necessary to select the appropriate procedure considering the patient's concerns and aesthetic sensibilities. The eyes are an area of primary concern for patients, yet surgery is the gold standard for treating ptosis. Oxymetazoline hydrochloride ophthalmic solution, 0.1%, is a safe and effective nonsurgical treatment for blepharoptosis.

Naphazoline and oxymetazoline are superior to epinephrine in enhancing the cutaneous analgesia of lidocaine in rats.

This study observed the cutaneous analgesic effect of adrenergic agonists when combined with lidocaine. We aimed at the usefulness of four adrenergic agonists and epinephrine as analgesics or as tools to prolong the effect of local anesthetics using a model of cutaneous trunci muscle reflex (pinprick pain) in rats. We showed that subcutaneous four adrenergic agonists and epinephrine, as well as the local anesthetic bupivacaine and lidocaine, developed a concentration-dependent cutaneous analgesia. The rank order of the efficacy of different compounds (ED50 ; median effective dose) was epinephrine [0.013 (0.012-0.014) µmol] > oxymetazoline [0.25 (0.22-0.28) µmol] > naphazoline [0.42 (0.34-0.53) µmol] = bupivacaine [0.43 (0.37-0.50) µmol] > xylometazoline [1.34 (1.25-1.45) µmol] > lidocaine [5.86 (5.11-6.72) µmol] > tetrahydrozoline [6.76 (6.21-7.36) µmol]. The duration of full recovery caused by tetrahydrozoline, oxymetazoline, or xylometazoline was greater (P < 0.01) than that induced via epinephrine, bupivacaine, lidocaine, or naphazoline at equianesthetic doses (ED25 , ED50 , and ED75 ). Co-administration of lidocaine (ED50 ) with four adrenergic agonists or epinephrine enhanced the cutaneous analgesic effect. We observed that four adrenergic agonists and epinephrine induce analgesia by themselves, and such an effect has a longer duration than local anesthetics. Co-administration of lidocaine with the adrenergic agonist enhances the analgesic effect, and the cutaneous analgesic effect of lidocaine plus naphazoline (or oxymetazoline) is greater than that of lidocaine plus epinephrine.

Oxymetazoline hydrochloride ophthalmic solution, 0.1%, boosts the effects of botulinum toxin on blepharospasm: a case series.

BACKGROUND: Oxymetazoline hydrochloride ophthalmic solution (0.1%) is a medication used to treat blepharoptosis. Patients who suffer from blepharoptosis have low-lying eyelids that can hinder their vision. Oxymetazoline hydrochloride ophthalmic solution (0.1%) is prescribed to patients to improve their vision by lifting the upper eyelids. Blepharospasm consists of involuntary, bilateral orbicularis oculi muscle movements that result in twitching and eyelid closure. Botulinum toxin is a treatment used to treat blepharospasm by preventing muscle contraction; but it is not always effective. CASE PRESENTATION: The effects of treatment with both oxymetazoline hydrochloride ophthalmic solution (0.1%) and botulinum toxin are assessed in three patients: (1) Patient A, a 58-year-old Filipina woman; (2) patient B, a 62-year-old Korean woman; and (3) patient C, A 57-year-old Vietnamese woman. All patients had been diagnosed with blepharoptosis as well as blepharospasm. Each patient was given an opportunity to complete an optional survey to assess not only the efficacy of oxymetazoline hydrochloride ophthalmic solution (0.1%) together with botulinum toxin but also their perceived stress during the past month. CONCLUSIONS: Administering botulinum toxin for the treatment of blepharospasm in patients A and B yielded the expected results; adding oxymetazoline hydrochloride ophthalmic solution (0.1%), a medical treatment for ptosis, to the treatment regimen yielded an unexpected reduction of blepharospasm. We propose that botulinum toxin and oxymetazoline hydrochloride ophthalmic solution (0.1%) can have a synergistic effect on reducing blepharospasm when used concomitantly. We present three cases in which combined use of botulinum toxin with oxymetazoline hydrochloride ophthalmic solution (0.1%) reduced blepharospasm, and propose possible reasons for such effects. We also discuss previous literature in agreement with the results of our cases.

Rosacea management: A comprehensive review.

Rosacea is a chronic cutaneous disorder affecting primarily the face, characterized by erythema, transient or persistent, telangiectasia, and inflammatory lesions including papulo-pustules and swelling. The essential component of the disease is the persistent erythema of facial skin. Episodes of flushing (acute-subacute intermittent vasodilation) are common. Swelling and erythema of the nose along with dilatation of the pilosebaceous poral orifices, known as rhinophyma, can be noted in chronic cases. Rosacea affects up to 10% of the world population and is especially noted in fair-skinned individuals aged 35-50. Women are affected more often than men. Several treatment modalities including topical medications, systemic drugs, lasers, and light-based therapies have been used for the management of rosacea with variable results. Topical medications such as azelaic acid, metronidazole, and sulfacetamide/sulfur, oral antibiotics such as tetracyclines, and oral retinoids alone or, most commonly, in combination form the mainstay of treatment. Light therapies such as intense pulsed light and pulsed dye laser are best used for the erythemato-telangiectatic type. Topical brimonidine, oxymetazoline, ivermectin, tacrolimus, pimecrolimus, low-dose modified-release tetracyclines and botulinum toxin are the new additions to the therapeutic armamentarium. This article provides a comprehensive review of the various therapies used for rosacea.

Successful treatment of knee erythromelalgia with topical oxymetazoline.

Erythromelalgia is an infrequent syndrome with a profound impact on quality of life. Its management is usually challenging and multiple treatments have been reported with variable response rates. To the best of our knowledge, we present the first case of erythromelalgia successfully treated with topical oxymetazoline.

Case Report: Treatment of Myasthenic Ptosis with Topical Ocular Oxymetazoline.

SIGNIFICANCE: Ptosis is often the hallmark finding in ocular and general myasthenia gravis. Reduction of ptosis has been achieved with oral and topical ocular medications. However, these medications can result in systemic and ocular adverse effects. A novel eye drop seems to be effective in reducing ptosis while minimizing adverse effects. PURPOSE: This case report aimed to demonstrate the efficacy of topical oxymetazoline hydrochloride 0.1%, an α-adrenergic agonist, in temporary elimination of ptosis associated with myasthenia gravis. CASE REPORT: A 68-year-old woman with a history of myasthenia gravis and long-standing ptosis in the right eye presented to improve the asymmetrical appearance of her eyelids. One drop of oxymetazoline hydrochloride 0.1% was instilled in the right eye of the patient. Within 2 hours, the ptosis was eliminated, the margin-reflex distance 1 increased by 2.0 mm, and the superior visual field measured by a superior 36-point screening test increased by 15 points. The effect lasted for at least 7 hours. Of note, there was a decrease in elevation of the contralateral nonptotic eyelid that did not receive a drop of oxymetazoline, which might occur only in myasthenia gravis. Further evaluation is warranted. CONCLUSIONS: Oxymetazoline 0.1% is effective in reducing and potentially eliminating ptosis related to ocular myasthenia gravis for up to 7 hours.

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 OBJECTIVES: We 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 METHODS: This 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. RESULTS: Statistically 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. CONCLUSION: The 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.

Prevention of middle ear barotrauma with oxymetazoline/fluticasone treatment.

Middle ear barotrauma (MEB) is a common complication of hyperbaric oxygen (HBO2) therapy. It has been reported in more than 40% of HBO2 treatments and can interrupt the sequence of HBO2. MEB may lead to pain, tympanic membrane rupture, and even hearing loss. The aim of this study was to determine if pretreatment with intranasal fluticasone and oxymetazoline affected the incidence of MEB. We conducted a retrospective chart review of subjects undergoing HBO2 at our institution between February 1, 2014, and May 31, 2019. Subjects in the fluticasone/oxymetazoline (FOT) treatment group used intranasal fluticasone 50 mcg two times per day and oxymetazoline 0.05% one spray two times per day beginning 48 hours prior to initial HBO2. Oxymetazoline was discontinued after four days. Fluticasone was continued for the duration of HBO2 therapy. A total of 154 unique subjects underwent 5,683 HBO2 treatments: 39 unique subjects in the FOT group underwent 1,501 HBO2; 115 unique subjects in the nFOT (no oxymetazoline or fluticasone treatment) group underwent 4,182 HBO2 treatments. The incidence of MEB was 15.4% in the FOT group and 16.2% in the nFOT group. This was not a statistically significant difference (OR = 0.77; p = 0.636). Treatment pressure, age over 65 years, male sex, and BMI were not associated with a difference in MEB incidence. In summary, pretreatment with intranasal oxymetazoline and fluticasone in patients undergoing HBO2 did not significantly reduce MEB. More investigation with larger numbers of participants and prospective studies could further clarify this issue.

Difference in vasoconstrictors: oxymetazoline vs. brimonidine.

OBJECTIVE: Topical oxymetazoline and brimonidine are the only medications approved for treating persistent facial erythema of rosacea. This review aims to investigate the efficacy, safety, pharmacodynamics, and pharmacokinetic properties of oxymetazoline and brimonidine. METHODS AND MATERIALS: Phase II and phase III clinical studies evaluating oxymetazoline and brimonidine were assessed to compare their efficacy and safety. RESULTS: In their respective phase III trials, both oxymetazoline and brimonidine met the primary efficacy outcome of having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment (SSA) Scales compared to the vehicle control. Treatment related adverse events of oxymetazoline and brimonidine are most often mild and localized. CONCLUSIONS: Topical oxymetazoline and brimonidine are effective for the management of persistent facial erythema associated with rosacea with a few mild and localized adverse effects. Further long-term research is imperative to further understand their long-term effects.

Investigation of Cytotoxic Effects of Oxymetazoline on Lungs in a Rat Model of Rhinitis Medicamentosa.

BACKGROUND: Rhinitis medicamentosa, also known as 'rebound congestion,' is inflammation of the nasal mucosa caused by the overuse of topical nasal decongestants. Although local decongestants resolve the initial nasal obstruction, the overuse causes rebound obstruction. However, how the overuse of the decongestant causes rhinitis medicamentosa is not known. OBJECTIVES: Here, we show the intracellular effects of oxymetazoline, commonly used a local decongestant, on the cell death pathways. We also investigated the antioxidative effects of erdosteine suspension (175 mg/5mL), an antioxidative agent. METHODS: Thirty Wistar-albino rats were used to form the rhinitis medicamentosa model. After rhinitis medicamentosa was clinically detected, we removed the whole lungs of animals to perform the molecular analyses of cell death pathways. RESULTS: We found a statistically significant decrease in the expression levels of Atg5 (p=0.021), Atg7 (p=0.013) and Ulk1 (p=0.036) in the oxymetazoline group compared to the control group (p<0.05); however, Caspase 3 expression level was recorded to be significantly increased in the oxymetazoline group, and the expression level of Beclin1 recorded to be substantially increased in the erdosteine group (p=0.001). CONCLUSION: Based on these grounds, we suggest that vasoconstriction in capillary vessels caused by oxymetazoline could lead to a decrease in the blood supply, which triggers autophagy to ensure cellular homeostasis.

Oxymetazoline and Energy-Based Therapy in Patients with Rosacea: Evaluation of the Safety and Tolerability in an Open-Label, Interventional Study.

BACKGROUND AND OBJECTIVES: The objectives of this study were to evaluate the safety, tolerability, and efficacy of oxymetazoline hydrochloride cream, 1% (oxymetazoline) when used as an adjunctive treatment with energy-based therapy for patients with moderate to severe facial erythema associated with rosacea. STUDY DESIGN/MATERIALS AND METHODS: In this Phase 4, multicenter, interventional, open-label study, eligible patients received one of four energy-based therapies (potassium titanyl phosphate laser, intense pulsed light therapy, pulsed-dye laser Vbeam Perfecta, or pulsed-dye laser Cynergy) on day 1 and day 29 and once-daily application of oxymetazoline on days 3 through 27 and days 31 through 56. Improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment-emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA) were assessed. Data were summarized using descriptive statistics. RESULTS: A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy-based therapies in addition to oxymetazoline. All patients demonstrated an improvement from baseline in CEA during the study with 39 of 43 evaluable patients (90.7%) demonstrating an improvement 6 hours posttreatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study. All TEAEs were mild or moderate in severity. Some patients experienced worsening in dermal tolerability assessment symptoms (range: 4-21 patients; 8.7-45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study. CONCLUSIONS: Treatment with oxymetazoline as adjunctive therapy with energy-based therapy was safe, well tolerated, and reduced facial erythema in patients with moderate to severe persistent facial erythema associated with rosacea. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

[Comparative study of the efficacy of combined nasal topical drug and topical decongestants in the treatment of acute rhinosinusitis]. / Sravnitel'noe issledovanie effektivnosti kombinirovannykh nazal'nykh topicheskikh preparatov i topicheskikh dekongestantov v lechenii ostrykh rinosinusitov.

OBJECTIVE: To evaluate the efficacy of the drug Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) comparison with Rinostop Extra (nasal spray oxymetazoline 0.05%) in relation to nasal symptoms of rhinosinusitis, evaluated on rating scales, when using these drugs intranasally for 7 days in patients with acute viral and post-viral rhinosinusitis of mild (VAS 0-3) and moderate (VAS 3-7). PATIENTS AND METHODS: The randomized open-label study included 60 ambulatory patients (men and women aged 18 to 60 years) with a verified diagnosis of acute rhinosinusitis (ARS) lasting no more than 120 hours. 1 group of patients took Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) for 2 sprays per each nostril 3 times a day for 7 days; 2 group - Rinostop Extra (nasal spray oxymetazoline 0.05%) at the same dose and the therapy regimen. We evaluated 3 visits (day 1, day 3, and day 7) with an ENT examination on each of them; questionnaires on the 1st and 3rd visits of nasal symptoms (nasal obstruction, rhinorrhea, hyposmia) on the visual analog scale (VAS) and Clinical Global Impression Scale-CGI. Active anterior rhinomanometry (AAR) was performed on the 1st, 2nd and 3rd visits using the PTS-14P-01 rhinomanometer Rinolan before and 20 minutes after the use of the drugs Frinozol and oxymetazoline 0.05%.

Microvascular Effects of Pulsed Dye Laser in Combination With Oxymetazoline.

BACKGROUND AND OBJECTIVE: Oxymetazoline, an α-1A agonist, is approved by the United States Food and Drug Administration (FDA) for treatment of persistent facial erythema associated with rosacea and induces vasoconstriction by interacting with α receptors. The objective of our study was to study the microvascular effects of oxymetazoline and pulsed dye laser (PDL). MATERIALS AND METHODS: A dorsal window chamber was surgically installed on 20 mice. Each animal was assigned to one of four experimental groups: saline alone, oxymetazoline alone (10 µl applied once daily × 7 days), saline + PDL (saline applied 5 minutes before PDL irradiation [10 mm spot, 1.5 ms pulse duration, 7 J/cm2 delivered to epidermis]), or oxymetazoline + PDL (10 µl oxymetazoline applied 5 minutes before PDL and then once daily × 7 days). Brightfield and laser speckle imaging were performed for 7 days to monitor vascular architectural and functional changes. RESULTS: We observed persistent blood flow in all of the saline-only and oxymetazoline-only experiments. A higher rate of vascular shutdown was observed with oxymetazoline + PDL (66.7%) compared with saline + PDL alone (16.7%). Oxymetazoline application increased venule diameter at 5 minutes post-application and decreased both arteriole and venule diameters at 60 minutes post-application. CONCLUSION: The combination protocol of oxymetazoline + PDL induces persistent vascular shutdown observed 7 days after irradiation. This result may be associated with the acute vascular effects of oxymetazoline. Oxymetazoline + PDL should be evaluated as a treatment for cutaneous vascular disease, including rosacea and port wine birthmarks. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Treatment of Erythematotelangiectatic Rosacea With Pulsed-Dye Laser and Oxymetazoline 1.0% Cream: A Retrospective Study.

BACKGROUND AND OBJECTIVES: Pulsed-dye laser (PDL) and oxymetazoline 1.0% cream are each used for the treatment of erythematotelangiectatic (ET) rosacea. PDL targets oxyhemoglobin and can reduce facial erythema and telangiectasias. Oxymetazoline 1.0% cream is an α adrenergic agonist, which has shown to reduce facial erythema. The aim of this study was to determine the degree of erythema improvement and telangiectasia clearance after combination treatment with PDL plus oxymetazoline 1.0% cream. STUDY DESIGN/MATERIALS AND METHODS: This retrospective study was conducted at two sites. Pre- and post-treatment cross-polarized images from subjects on combination treatment with PDL and oxymetazoline 1.0% cream were graded by a board-certified dermatologist at each practice. Blinded images were analyzed using the Clinical Erythema Assessment (CEA) Scale (0 = clear and 4 = severe). Unblinded images were analyzed using the five-point Telangiectasia Scale to determine the degree of improvement post-treatment compared with baseline (1 = <5% clearance and 5 = 75-100% clearance). RESULTS: Thirty-one subjects (20 females, 11 males) of age 51 ± 13 years (mean ± standard deviation) were included in the study after an average of 4 months (range: 1-13) of daily oxymetazoline 1.0% cream and two (range: 1-4) PDL treatments. At baseline, 87% of subjects had CEA Grade 2 (mild erythema) or higher. For erythema, 55% of subjects improved by at least one CEA grade and 13% achieved two grades of improvement post-treatment. For telangiectasias, 90% of subjects achieved at least a two-point clearance (5-25%), 62% at least a three-point clearance (25-50%), and 41% at least a four-point clearance (50-75%) post-treatment. Compared with subjects with baseline CEA Grade 1-2 (almost clear to mild erythema), significantly more subjects with baseline CEA Grade 3-4 (moderate to severe erythema) achieved at least one CEA grade of improvement (P = 0.021) and two grades of CEA improvement (P = 0.041). A higher percentage of baseline CEA Grade 3-4 subjects achieved at least a two-point clearance in telangiectasias (P = 0.055). CONCLUSIONS: Combination treatment with PDL and daily oxymetazoline 1.0% cream can safely and effectively reduce erythema and telangiectasias. Limitations include the retrospective design of the study, small sample size, and lack of a control group. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

The effects of nasal decongestion on obstructive sleep apnoea.

BACKGROUND: Many studies have indicated associations between impaired nasal breathing and sleep disorders. However, the precise nature of the relationship between nasal patency and sleep remains unclear. PURPOSE: We analysed the effects of nasal patency on sleep architecture and breath in nasal obstruction-predominant obstructive sleep apnoea (NO-OSA) patients by applying nasal decongestant. MATERIAL AND METHODS: A randomized, placebo-controlled double-blind crossover study was performed in OSA patients with chronic nasal obstruction and without obvious pharyngeal narrowing. All OSA patients (confirmed by polysomnography) were recruited and completed 2 overnight studies (randomly applying oxymetazoline or placebo). Data collected after oxymetazoline or placebo treatments were compared. The ClinicalTrials.gov identifier is NCT03506178. RESULTS: Compared with placebo, oxymetazoline resulted in significant increase in rapid eye movement sleep (p = 0.027) and reduction of stage 1 sleep (p = 0.004), as well as arousal index (p = 0.002). Moreover, great improvements in apnoea/hypopnea index (AHI) were observed (p < 0.001); AHI in the supine position was significantly reduced (p = 0.001). Oxygen saturation during sleep was increased significantly [mean oxygen saturation (p = 0.005) and lowest oxygen saturation (p = 0.024)]. Oxygen desaturation index was significantly reduced (p < 0.001). CONCLUSIONS: Improving nasal patency by decongestant could improve sleep quality, AHI, and oxygen saturation level during sleep.

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

BACKGROUND: Topical α-agonists contract the internal anal sphincter muscle; therefore, they may serve as treatment for fecal incontinence. OBJECTIVES: 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. DESIGN: This was a double-blind, crossover study. Before randomization, all patients underwent a 1-day, open-label anal manometry and pharmacokinetic study. SETTINGS: The study was conducted at the Department of Internal Medicine, Semmelweis University, Hungary. PATIENTS: 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. MAIN OUTCOME MEASURES: The primary outcome measured was the number of fecal incontinence episodes in the 8 and 12 hours after drug administration. RESULTS: 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. LIMITATIONS: The study was limited by the small number of participants. CONCLUSIONS: 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.

Topical Oxymetazoline Cream 1.0% for Persistent Facial Erythema Associated With Rosacea: Pooled Analysis of the Two Phase 3, 29-Day, Randomized, Controlled REVEAL Trials

Background: Rosacea is a chronic dermatologic condition with limited treatment options. Methods: Data were pooled from two identically designed phase 3 trials. Patients with moderate to severe persistent erythema of rosacea were randomized to receive oxymetazoline cream 1.0% or vehicle once daily for 29 days and were followed for 28 days posttreatment. The primary efficacy outcome was the proportion of patients with ≥2-grade improvement from baseline on both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) at 3, 6, 9, and 12 hours postdose, day 29. Results: The pooled population included 885 patients (78.8% female); 85.8% and 91.2% had moderate erythema based on CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline than vehicle group (P<0.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P<0.001). The incidence of treatment-emergent adverse events was low (oxymetazoline, 16.4%; vehicle, 11.8%). No clinically relevant erythema worsening (based on CEA and SSA) was observed during the 28-day posttreatment follow-up period (oxymetazoline, 1.7%; vehicle, 0.6%). Conclusion: Oxymetazoline effectively reduced moderate to severe persistent facial erythema of rosacea and was well tolerated. J Drugs Dermatol. 2018;17(11):1201-1208.