A comparison of the efficacy and tolerability of topical agents used in facial Demodex treatment.

BACKGROUND: Demodex spp. is the most common ectoparasite in humans. This parasite is believed to play a role in the etiology of many dermatological and ocular disorders. AIM: The aim of this study was to compare the efficacy and tolerability of the sulfur-sodium sulfacetamide combination, crotamiton, and permethrin, which are three topical agents commonly used in Demodex treatment. METHODS: A total of 28 patients with primary demodicosis and 44 patients with Rosacea + Demodex were included in the study. The pretreatment and post-treatment Demodex spp. counts, patient satisfaction, and erythema decrease rates were compared. RESULTS: Analysis of the efficacy of these topical agents on Demodex revealed that all three significantly decreased the number of parasites. The patient satisfaction was higher in the sodium acetamide group than the 10% crotamiton and 5% permethrin groups, and clinical evaluation (erythema/ papulopustules and white plugs) was better in the sodium acetamide group than the other groups but no statistically significant difference was found in terms of patient satisfaction and clinical evaluation. CONCLUSION: The sulfur-sodium combination, crotamiton, and permethrin are the three agents commonly used in the treatment of Demodex spp. and all significantly decreased the Demodex count. The three agents were similar in terms of tolerability. Our study needs to be supported with others on larger patient series.

The use of sodium sulfacetamide in dermatology.

Sodium sulfacetamide is effective in the management of a variety of inflammatory facial dermatoses and often is used in combination with sulfur for a synergistic effect. Adverse effects from sodium sulfacetamide are rare and generally are limited to mild application-site reactions. This agent is contraindicated in any patient with known hypersensitivity to sulfonamides.

Rosacea: update on management and emerging therapies.

Rosacea is a common chronic skin disorder that has significant impact on the self-esteem and quality of life of affected individuals. Currently understood as an inflammatory condition that occurs in the context of an altered innate immune response, the available topical and systemic therapies function as immunomodulators to restore cutaneous homeostasis. The goals of therapy include reduction of papules, pustules, erythema and physical discomfort with improvement in quality of life. Standard topical treatments include metronidazole and azelaic acid, although many other agents and regimens have been presented. Subantimicrobial/antiinflammatory dose oral doxycycline was US FDA approved in 2006 for the management of rosacea, but Health Canada clearance was only recently granted for this indication. Furthermore, renewed research interest has led to the development of other emerging therapies including topical ivermectin, brimonidine and oxymetazoline that hold promise for patients suffering from this condition.

Comparison of the efficacy of topical N-acetyl-cysteine and a topical steroid-antibiotic combination therapy in the treatment of meibomian gland dysfunction.

PURPOSE: This study aimed to compare the efficacy of topical N-acetyl-cysteine (NAC) with a topical steroid-antibiotic combination, betamethasone-sulfacetamide sodium therapy in patients with meibomian gland dysfunction (MGD). METHODS: Twenty patients with MGD were prospectively randomized and assigned into 2 groups. The patients were instructed to use either NAC 5% or a topical steroid-antibiotic combination, betamethasone 0.1%-sulfacetamide sodium 10%, topically 4 times a day for a month. All patients were instructed to apply lid hygiene once daily. RESULTS: One month of topical therapy provided statistically significant improvements in fluorescein break-up time and Schirmer scores as compared with the initial study visit in both groups (P≤0.001). Significant improvements for the symptoms of ocular burning, itching, and intermittent filmy or blurred vision were noted in both groups at 1 month as compared with 1 day (P<0.05). Considering these rates, there was no significant difference between the groups (P>0.05). None of the patients developed an allergic reaction to the medications, and intraocular pressure measurements were within the normal limits in both groups. CONCLUSION: When used in conjunction with eyelid hygiene, topical administration of NAC appears to be as effective as a topical steroid-antibiotic combination, betamethasone-sulfacetamide sodium therapy in patients with MGD.

The multifunctionality of 10% sodium sulfacetamide, 5% sulfur emollient foam in the treatment of inflammatory facial dermatoses.

Prior to 1962, some of the most versatile drugs in dermatology were approved by the U.S. Food and Drug Administration (FDA) solely on the basis of safety. One of these is the combination 10% sodium sulfacetamide and 5% sulfur. Sodium sulfacetamide possesses anti-inflammatory and antibacterial properties while sulfur is a nonspecific antibacterial and antifungal. A new emollient foam formulation of 10% sodium sulfacetamide and 5% sulfur allows a thinner application film and leaves behind no residue on hair bearing or non-hair bearing skin. The sulfur smell is also more quickly dissipated with reduced irritation. This uncontrolled, observational, prospective, open-label, single site, eight-week study enrolled 24 subjects (eight with rosacea, eight with seborrheic dermatitis, eight with acne vulgaris) to evaluate the safety and efficacy of this novel foam formulation. At eight weeks, statistically significant improvement was seen in inflammatory rosacea lesion counts and the signs of seborrheic dermatitis. A 50% reduction was noted in the total acne lesion counts. These findings confirm the versatility of an emollient 10% sodium sulfacetamide and 5% sulfur foam.

Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing topical regimens for the treatment of papulopustular rosacea: results from a community-based trial.

Rosacea is a prevalent inflammatory skin disorder that affects approximately 16 million individuals in the United States. Although its exact etiology is unknown, basic science, histologic evidence, and clinical evidence suggest that it is inflammatory in nature. In this 12-week, open-label, multicenter, community-based, phase 4 trial, we evaluated the anti-inflammatory effects of once daily subantimicrobial-dose doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) in participants with papulopustular rosacea (PPR) who were receiving topical therapy (metronidazole, azelaic acid, and/ or sodium sulfacetamide-sulfur) at the time of the study entry but whose rosacea symptoms were still present. The primary outcome measure was the change in the investigator global assessment (IGA) score from baseline to end of study (week 12). Secondary outcome measures were changes from baseline to end of study in the clinician erythema assessment (CEA) score, treatment responders (IGA score of clear, near clear), and safety. After week 12, 75.7% of participants in the per-protocol (PP) population had IGA scores of clear or near clear. In addition, there were significant differences in the distribution of baseline and week 12 IGA scores in the PP group (P = .0012). At week 12, most participants (63.6%) had mild CEA scores; the distribution was significantly different from baseline (P = .0407). Only 7% of participants had treatment-related adverse events (AEs), mostly mild or moderate in severity. Thus the 40-mg formulation of doxycycline proved to be effective and well-tolerated in a real-world setting in participants with rosacea who were receiving topical therapy but still experiencing symptoms.

Sulfacetamide loaded Eudragit® RL100 nanosuspension with potential for ocular delivery.

PURPOSE: Polymeric nanosuspension was prepared from an inert polymer resin (Eudragit® RL100) with the aim of improving the availability of sulfacetamide at the intraocular level to combat bacterial infections. METHODS: Nanosuspensions were prepared by the solvent displacement method using acetone and Pluronic® F108 solution. Drug to polymer ratio was selected as formulation variable. Characterization of the nanosupension was performed by measuring particle size, zeta potential, Fourier Transform infrared spectra (FTIR), Differential Scanning Calorimetry (DSC), Powder X-Ray Diffraction (PXRD), drug entrapment efficiency and in vitro release. In addition, freeze drying, redispersibility and short term stability study at room temperature and at 4(0)C were performed. RESULTS: Spherical, uniform particles (size below 500 nm) with positive zeta potential were obtained. No significant chemical interactions between drug and polymer were observed in the solid state characterization of the freeze dried nanosuspension (FDN). Drug entrapment efficiency of the selected batch was increased by changing the pH of the external phase and addition of polymethyl methacrylate in the formulation. The prepared nanosuspension exhibited good stability after storage at room temperature and at 4(0)C. Sucrose and Mannitol were used as cryoprotectants and exhibited good water redispersibility of the FDN. CONCLUSION: The results indicate that the formulation of sulfacetamide in Eudragit® RL100 nanosuspension could be utilized as potential delivery system for treating ocular bacterial infections.

Interaction of topical sulfacetamide and topical dapsone with benzoyl peroxide.

BACKGROUND: A recent study demonstrated evidence of a yellow-orange discoloration of the skin and hair when topical dapsone gel was combined with benzoyl peroxide. This phenomenon had previously been observed by one of us (A.B.F.) when sulfasalazine was combined with benzoyl peroxide. To investigate these interaction phenomena, topical dapsone gel and sulfacetamide sodium lotion were combined with various topical acne treatments, including benzoyl peroxides, clindamycin phosphate, and retinoids. OBSERVATIONS: Products containing benzoyl peroxide produced an orange-brown discoloration when mixed with either sulfacetamide or dapsone. CONCLUSIONS: Knowledge of the chemical reaction between benzoyl peroxide and sulfacetamide and dapsone will help minimize the occurrence of this interaction on our patients' skin.

Treatment of papulopustular rosacea with sodium sulfacetamide 10%/sulfur 5% emollient foam.

Acne rosacea is a chronic cutaneous disorder affecting as many as 14 million Americans. Papulopustular rosacea is the classic form of rosacea characterized by papules, pustules, and erythema. The skin barrier deficiency and vascular hyperactivity characteristic of papulopustular rosacea increase skin dryness and irritation, which can be further exacerbated by medications commonly used to treat rosacea. Sodium sulfacetamide 10%/sulfur 5% emollient foam (SSSE foam) is formulated for topical administration and is fragrance free and alcohol free. This nonrandomized, noncontrolled, open-label, prospective case series was designed to evaluate the efficacy and safety of a SSSE foam for the treatment of papulopustular rosacea in 8 patients. Patients experienced clinically significant improvements in the severity of rosacea with a favorable safety profile, and reported of an improved quality of life. The high patient satisfaction ratings for SSSE foam suggest that the product may improve long-term compliance rates, with the potential to yield more favorable clinical outcomes.

Rosacea and its topical management.

Many options exist for the treatment of rosacea, including topical and systemic therapies, laser and light-based therapies, and surgical procedures. A classification system for rosacea identifies 4 subtypes (i.e., erythematotelangiectatic, papulopustular, phymatous, and ocular), which may help guide therapeutic decision-making. The goals of therapy include reduction of papules, pustules, erythema, physical discomfort, and an improvement in quality of life. Standard topical treatment agents include metronidazole, azelaic acid, and sodium sulfacetamide-sulfur. Second line therapies include benzoyl peroxide, clindamycin, calcineurin inhibitors, and permethrin.

Bioadhesive sulfacetamide sodium microspheres: evaluation of their effectiveness in the treatment of bacterial keratitis caused by Staphylococcus aureus and Pseudomonas aeruginosa in a rabbit model.

The aim of this study was to prepare bioadhesive sulfacetamide sodium (SA) microspheres to increase their residence time on the ocular surface and to enhance their treatment efficacy on ocular keratitis. Microspheres were fabricated by spray drying method using mixture of polymers such as pectin, polycarbophil and hydroxypropylmethyl cellulose (HPMC) at different ratios. The particle size and distribution, morphological characteristics, thermal behavior, encapsulation efficiency, mucoadhesion and in vitro drug release studies on formulations have been investigated. After optimisation studies, SA-loaded polycarbophil microsphere formulation with polymer:drug ratio of 2:1 was found to be the most suitable for ocular application and used in in vivo studies. In vivo studies were carried out on New Zealand male rabbit eyes with keratitis caused by Pseudomonas aeruginosa and Staphylococcus aureus. Sterile microsphere suspension in light mineral oil was applied to infected eyes twice a day. Plain SA suspension was used as a positive control. On 3rd and 6th days of the antimicrobial therapy, the eyes were examined in respect to clinical signs of infection (blepharitis, conjunctivitis, iritis, corneal oedema and corneal infiltrates) which are the main symptoms of bacterial keratitis and then cornea samples were counted microbiologically. The rabbit eyes treated with microspheres demonstrated significantly lower clinical scores than those treated with SA alone. A significant decrease in the number of viable bacteria in eyes treated with microspheres was observed in both infection models when compared to those treated with SA alone. In conclusion, in vitro and in vivo studies showed that SA-loaded microspheres were proven to be highly effective in the treatment of ocular keratitis.

Pilot investigation of the hydrating effects of topical acne medications.

Topical therapies are effective in managing acne vulgaris but are associated with local adverse effects such as irritation and dryness. This 4-week pilot study compared skin hydration in 36 healthy adult women randomized to treatment with 1 of 4 topical therapies: 2 different (jar and tube) clindamycin 1%/benzoyl peroxide 5% gels, sodium sulfacetamide 10% lotion, or over-the-counter (OTC) moisturizing cream. Subjects treated with OTC moisturizer or sodium sulfacetamide exhibited decreased water loss, increased water retention, similar or improved levels of skin hydration, and decreased desorption rates. In contrast, subjects treated with jar or tube clindamycin/benzoyl peroxide had increased water loss, decreased water retention, decreased hydration, and increased desorption rates. Skin dryness decreased slightly in the moisturizer group. No serious adverse events occurred. Overall, the OTC moisturizer had the best skin hydration profile. Sodium sulfacetamide demonstrated some moisturizing characteristics, and no clinically relevant differences were noted between jar and tube clindamycin/benzoyl peroxide gels.

Topical therapies for rosacea.

Therapeutic options for rosacea include topical agents, oral therapies, laser and light treatments, and surgical procedures. Topical therapies play a critical role in the treatment of patients with papulopustular rosacea and erythematotelangiectatic rosacea, and have the ability to effectively minimize certain manifestations of the disease, including papules, pustules, and erythema. The 3 primary agents for the topical treatment of rosacea are metronidazole, azelaic acid, and sodium sulfacetamide-sulfur. Each of these therapies is approved for the treatment of rosacea and has been validated by multiple studies. Additional topical therapies including benzoyl peroxide, clindamycin, retinoids, topical steroids, calcineurin inhibitors, and permethrin are not approved for the treatment of rosacea and play variable roles in the management of this condition.

Refractory Demodex folliculitis in five children with acute lymphoblastic leukemia.

We report five children with acute lymphocytic leukemia on maintenance chemotherapy who had Demodex folliculitis. None experienced complete clearing when treated with permethrin 5% cream. Topical metronidazole helped to lessen the eruption in four, but did not provide full clearing. The one child who was treated with sodium sulfacetamide 10%, sulfur 5% formulation had resolution of the eruption. We suggest that treatment of Demodex folliculitis in children with acute lymphocytic leukemia is more difficult than is suggested in the literature. Newer sodium sulfacetamide/sulfur formulations should be considered when treating this condition, particularly in children with acute lymphocytic leukemia.

Combination sodium sulfacetamide 10% and sulfur 5% cream with sunscreens versus metronidazole 0.75% cream for rosacea.

Topical metronidazole and combination sodium sulfacetamide and sulfur commonly are used to treat rosacea. Recently, the relative efficacy and safety of sodium sulfacetamide 10% and sulfur 5% cream with sunscreens (Rosac Cream) (n = 75) and metronidazole 0.75% cream (Metrocream) (n = 77) were compared in an investigator-blinded, randomized, parallel-group study at 6 sites. After 12 weeks of treatment with sodium sulfacetamide 10% and sulfur 5% cream with sunscreens, there was a significantly greater percentage reduction (80%) in inflammatory lesions compared with metronidazole 0.75% cream (72%)(P = .04), as well as a significantly greater percentage of subjects with improved erythema (69% vs 45%, respectively; P = .0007). In addition, the sodium sulfacetamide 10% and sulfur 5% cream with sunscreens group had a significantly greater proportion of subjects with success in global improvement at week 12 compared with the metronidazole 0.75% cream group (79% vs 59%, respectively; P = .01). There was no significant difference between treatment groups in the percentage of subjects with improvement in investigator global severity. Overall tolerance was good or excellent in 85% of subjects in the sodium sulfacetamide 10% and sulfur 5% cream with sunscreens group and in 97% of subjects in the metronidazole 0.75% cream group. Seven subjects had poor tolerance to the sodium sulfacetamide 10% and sulfur 5% cream with sunscreens, possibly caused by a sulfa drug allergy.

Topical metronidazole combination therapy in the clinical management of rosacea.

Metronidazole was the first topical agent approved by the U.S. Food and Drug Administration for the treatment of rosacea. Several controlled studies have confirmed the efficacy and safety of topical metronidazole 0.75% gel, lotion and cream and 1% cream for rosacea. At present, little data exists regarding the use of combination topical therapy in rosacea management, although anecdotal evidence and preliminary studies suggest at least some additive benefit when topical metronidazole is used in combination with sulfacetamide 10% /sulfur 5%. In this paper, the results of observational experience evaluating topical metronidazole 0.75% gel used in combination with other topical rosacea therapies and/or subantimicrobial dose doxycycline are reported.

Diagnosing and managing the patient with rosacea.

Rosacea is a common, chronic facial dermatosis that may present in varying manners. Subtypes of rosacea include erythematotelangiectatic, papulopustular, phymatous, and ocular. In this article, we discuss the diagnosis of these rosacea subtypes and focus on the therapeutics specific to each. Treatments include topical agents, oral antibiotics, laser therapies, surgical treatments, and the role of cosmetics and skin care.

The use of sulfur in dermatology.

Sulfur has antifungal, antibacterial, and keratolytic activity. In the past, its use was widespread in dermatological disorders such as acne vulgaris, rosacea, seborrheic dermatitis, dandruff, pityriasis versicolor, scabies, and warts. Adverse events associated with topically applied sulfur are rare and mainly involve mild application site reactions. Sulfur, used alone or in combination with agents such as sodium sulfacetamide or salicylic acid, has demonstrated efficacy in the treatment of many dermatological conditions.

A double-blind comparative study of sodium sulfacetamide lotion 10% versus selenium sulfide lotion 2.5% in the treatment of pityriasis (tinea) versicolor.

Pityriasis (tinea) versicolor, which consists of hyperpigmented and hypopigmented scaly patches, is often difficult to treat. A double-blind comparative study between once-a-day sodium sulfacetamide lotion and selenium sulfide lotion was undertaken. Both treatments were safe and efficacious. Selenium sulfide was statistically more efficacious (76.2% vs 47.8%, P=.013).