Nanoemulgel for Improved Topical Delivery of Desonide: Formulation Design and Characterization.

This research aimed to develop a novel drug delivery system to improve treatment of skin disorders. The system is comprised of a Carbopol 980-based nanoemulgel (NE-gel) containing a desonide (DES; 0.05%, w/w) nanoemulsion (NE), which has a small particle size, high encapsulation efficiency, good thermodynamic stability, good permeation ability, and high skin retention. DES-loaded NE (DES-NE) was prepared by high-pressure homogenization. The developed formulation was characterized by differential scanning calorimetry (DSC), X-ray diffraction, drug release, skin permeation, and drug retention. DES in vitro release and skin permeation studies with different formulations of artificial membrane and rat abdominal skin were performed with the Franz diffusion cell system. Confocal laser scanning microscopy (CLSM) was used to detect the localization and permeation pathways of drugs in the skin. Compared with commercially available gel (CA-gel) and NE, the NE-gel release process conformed to the Higuchi release model (R2 = 0.9813). NE-gel prolonged the drug release time and allowed for reduced administration dose and frequency. The unit cumulative permeation of NE and NE-gel through the skin for 12 h was 63.13 ± 2.78 and 42.53 ± 2.06 µg/cm2, respectively, values significantly higher (p < 0.01) than that of the CA-gel (30.65 ± 1.25 µg/cm2) and CA-cream (15.21 ± 0.97 µg/cm2). The DES-NE and DES NE-gel skin drug retention was significantly higher than commercially available formulations (p < 0.01). Hence, the prepared NE-gel is a potential vehicle for improved topical DES delivery for better treatment of skin disorders.

Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study.

BACKGROUND: Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing. METHODS: A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared. RESULTS: Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001). CONCLUSIONS: The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.

Topical Treatment for the Management of Atopic Dermatitis

Atopic dermatitis affects up to 20% of children and continues to increase in prevalence. Effective disease control is aimed at decreasing symptoms and reducing the frequency of flares, which may be complicated by secondary bacterial infections. Although recent advances have produced a number of non-systemic treatment options, topical corticosteroids remain a fundamental component of treatment algorithms. J Drugs Dermatol. 2019;18(2 Suppl):s112-116.

The triad of pruritus, xanthomas, and cholestasis: Two cases and a brief review of the literature.

When encountered in children, xanthomas are most commonly associated with a group of disorders known as familial hyperlipidemias. Aside from cosmetic concerns, these xanthomas are typically asymptomatic, but when generalized pruritus is a prominent associated symptom, clinicians should consider a different set of diagnoses that includes cholestasis of the liver. In this article we present two illustrative cases of children with cholestatic disease, pruritus, and xanthomas and discuss other disorders that may include this triad.

The effect of desonide hydrogel on pruritis associated with atopic dermatitis.

Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most AD patients. Instead, anti-inflammatory agents are used to reduce inflammation and therefore improve associated itch. Studies confirm that long-term use of corticosteroids can lead to a reduction in pruritus. A pilot study was designed to assess the effects of one week of twice-daily application of desonide hydrogel 0.05% for the treatment of atopic dermatitis. Active treatment was associated with significant improvements in IGA scores at day 3 and day 7 (mean score 0.55, 75.83% improvement from Baseline; P <.0001) and pruritus VAS scores at day 3 and day 7 (mean 6.35-point, 86.61% reduction in VAS scores; P <.0001). Treatment with the convenient, hydrating hydrogel formulation is effective and associated with an improvement in subjects' quality of life.

Allergic contact dermatitis to a laptop computer in a child.

This report details the case of an 11-year-old boy with a history of atopic dermatitis who developed a widespread dermatitis 1 month after receiving a laptop for Christmas. Allergic contact dermatitis to nickel in the laptop was determined as the cause.

The importance of vehicle properties to patients with atopic dermatitis.

The properties of vehicle formulations may influence drug delivery, efficacy, and tolerance profiles of topical medications. Patient preferences vary and the importance of certain aesthetic attributes depend on the disease state, the site of application, and the length and extent of treatment, among other factors. Formulations that offer aesthetic advantages over traditional vehicles may improve patients' willingness to apply therapy as directed and therefore may affect the outcome of treatment. A participant preference study was conducted to determine if an aqueous gel (hydrogel) formulation of desonide would appeal to patients with atopic dermatitis (AD). Before treatment adult participants with AD completed a questionnaire to assess their AD history and prior topical treatments and to rate the importance of topical vehicle attributes. Each participant then applied desonide hydrogel 0.05% to affected areas twice daily for 4 weeks. At the end of the treatment, participants were queried on the attributes of desonide hydrogel and how it compared with other vehicles previously used. Twenty-two participants with mild to moderate AD completed the study; 100% (22/22) of participants found desonide hydrogel to be easy to apply/use/spread, easy to use on hair-bearing skin, comfortable to use under makeup and/or cosmetics, suitable for use on multiple body areas, and stain free. Most participants reported that the product was soothing (82% [18/22]), did not dry the skin (96% [21/22]), disappeared quickly (82% [18/22]), was comfortable to wear under clothes (91% [20/22]), and was not greasy or shiny on skin (96% [21/22]).

Self-reported participant experience with desonide hydrogel in the treatment of mild to moderate atopic dermatitis.

The objective of this study was to evaluate patients' real-world experiences with desonide hydrogel for the treatment of mild to moderate atopic dermatitis (AD). Physicians who participated in this patient-experience program identified eligible participants (age range, < 3 months to 91 years) for treatment with desonide hydrogel 0.05%. The medication was prescribed by each participant's physician according to his/her practice guidelines and was provided to the participant at no charge. Patients (or their parents/guardians) voluntarily participated by providing consent and completing 2 surveys: one at baseline (pretreatment) and the other approximately 3 weeks after initiation of desonide hydrogel treatment (posttreatment). The pretreatment survey included questions about prior topical medication use for AD and satisfaction with prior treatments. The second survey assessed compliance with desonide hydrogel, satisfaction with treatment, characteristics of desonide hydrogel, intent to continue treatment, and willingness to recommend desonide hydrogel to others. A total of 1185 participants completed both the pretreatment and posttreatment surveys. Participant satisfaction with desonide hydrogel was 95% greater than satisfaction with prior topical medications for AD (P < .01). Adherence to treatment with desonide hydrogel was more than 80% based on reports from participants. Eighty-nine percent of participants reported that they would continue to use the medication for their condition if needed and 85% would recommend desonide hydrogel to others. Prescribing physicians received individual summaries of survey responses reported by each of his/her participating patients, which provided valuable feedback regarding participants' perceptions of treatment. Participants reported favorable experiences after treatment with desonide hydrogel compared with prior topical therapies. Desonide is widely prescribed for the treatment of AD.

Moisturizing advantages of desonide hydrogel in treating atopic dermatitis.

The stratum corneum typically is compromised in patients with atopic dermatitis (AD). Beneficial AD treatments should provide moisture to the skin as well as restore impaired barrier function. Traditional treatments involve ointments or creams. A clinical study was conducted to determine if desonide in a hydrogel vehicle (HGV) could improve the moisture content and barrier function of the stratum corneum in adults with mild to moderate AD. Participants applied desonide hydrogel 0.05% twice daily for 4 weeks to areas of both lesional and nonlesional skin. Corneometry and transepidermal water loss (TEWL) were measured at baseline and weeks 1, 2, and 4. Statistically significant improvements in corneometry and TEWL measurements on lesional skin were observed at all study visits compared with baseline (all P < or = .002 and P < or = .04, respectively).

Rhabdomyomatous mesenchymal hamartoma: clinical overview and report of a case with spontaneous regression.

A case of cutaneous rhabdomyomatous mesenchymal hamartoma in a 6-year-old Afro-Caribbean girl is reported with review of the literature. The lesions were fine, located on the central face and became inapparent after six months. Spontaneous regression of these lesions has not been previously reported. Although rare, continued reporting will facilitate the elucidation of the clinical features and natural history of these lesions and the relationship to disordered embryogenesis.

Crusted scabies mimicking an acrodermatitis continua of Hallopeau.

Background: Crusted scabies (CS) is an uncommon, highly contagious, variant of classic scabies. Elevated concentrations of the mite Sarcoptes scabiei var. hominis are found in the skin lesions, which lead to a more exaggerated clinical picture than in classic scabies. This disease is mainly observed in patients with any kind of immunosuppression and relates to Down syndrome. Case report: A pediatric female patient with Down syndrome, who presented a crusty white plaque associated with nail dystrophy and subungual hyperkeratosis affecting the distal portion of the fingers is described. Because of these findings, the diagnosis of acrodermatitis continua of Hallopeau was considered. A punch biopsy was performed, attaining the diagnosis of CS. She received systemic treatment with oral ivermectin, topical treatment with emollient cream and desonide 0.1%. Notorious clinical improvement was observed two weeks after finalizing treatment. Conclusions: CS is variant of scabies prevalent in immunocompromised patients and Down syndrome that can be easily confused with inflammatory pathologies with abnormal epidermal keratinization. This case is considered as an atypical presentation of the disease because of local affection of the fingers and nail dystrophy. The histopathological study was necessary to obtain the diagnosis and rule out differential diagnosis.

Introducción: La escabiasis costrosa (EC) es una variante poco común de sarcoptiosis clásica, altamente contagiosa. Las lesiones poseen una elevada concentración del ácaro Sarcoptes scabiei var hominis, lo que conlleva a un cuadro clínico más extenso que en la escabiasis clásica. Se observa principalmente en pacientes con algún tipo de inmunocompromiso y se relaciona con el síndrome de Down. Caso clínico: Se describe una paciente pediátrica con síndrome de Down quien presentó placas escamosas que afectaron la porción distal de los dedos, asociadas con distrofia ungueal e hiperqueratosis subungueal, por lo que se consideró acrodermatitis continua de Hallopeau como diagnóstico diferencial. Se realizó una biopsia tipo punch con lo que se llegó al diagnóstico de EC. La paciente recibió tratamiento sistémico con ivermectina vía oral y tratamiento tópico con crema hidratante y desonida al 0.1%. Mostró mejoría clínica notoria dos semanas después de finalizar el tratamiento. Conclusiones: La EC es una variante prevalente en pacientes inmunocomprometidos y con síndrome de Down que fácilmente puede confundirse con patologías inflamatorias con alteración de la queratinización epidérmica. Este caso se considera una presentación atípica debido a la afección localizada en los dedos de las manos asociada con distrofia ungueal. El estudio histopatológico fue necesario para realizar el diagnóstico y descartar diagnósticos diferenciales.

Nephrotic state as a risk factor for developing posterior reversible encephalopathy syndrome in paediatric patients with nephrotic syndrome.

BACKGROUND: Posterior reversible encephalopathy syndrome (PRES) is a distinctive and potentially serious complication of the nephrotic syndrome. The objective of the present study is to characterize the factors predisposing the development of PRES in paediatric patients with nephrotic syndrome. METHODS: We investigated paediatric patients with idiopathic nephrotic syndrome who developed PRES between 1999 and 2005 in our institution. Patients with steroid-sensitive nephrotic syndrome and those with steroid-resistant nephrotic syndrome that were proven to be idiopathic were eligible. RESULTS: In total, seven patients ranging in age from 1.5 to 15.1 years old were analysed. At the onset of PRES, six of the seven patients were in a nephrotic state. Various degrees of acute renal insufficiency were shown in four patients. The re-administration of cyclosporine after the episodes of PRES was carried out in four patients. During the observation for 17-51 months after the re-administration, the recurrence of PRES did not develop in these patients. CONCLUSIONS: The development of PRES occurred at the time of moderate to severe nephrotic state in most of our paediatric patients with nephrotic syndrome. Besides the administration of cyclosporine and having hypertension, there appear to be several additive factors predisposing the development of PRES in these patients, namely low serum albumin level, generalized oedema, increase in vascular permeability, unstable fluid status and renal insufficiency. The re-administration of cyclosporine to those patients with anamnesis of PRES may be considered after the management and close monitoring of these factors as well as hypertension.

Desonide foam 0.05%: safety in children as young as 3 months.

BACKGROUND: Desonide 0.05% was recently developed in an emulsion foam formulation. OBJECTIVE: The safety of desonide foam 0.05% in children aged 3 months to 17 years was evaluated in two phase II studies and one phase III study. METHODS: A phase II open-label study of the effect of desonide foam 0.05% on the hypothalamic-pituitary-adrenal axis was evaluated in pediatric and adolescent participants with mild-to-moderate atopic dermatitis. The phase II and III clinical efficacy studies evaluated adverse events. RESULTS: At the end of the 4-week treatment in the phase II study, 4% (3 of 75) of participants experienced mild, reversible hypothalamic-pituitary-adrenal-axis suppression. The combined safety data from the phase II and III studies revealed 6% of participants in the desonide foam group and 14% in the vehicle foam group reported adverse events (P = .0002), with application site burning as the most commonly reported adverse event (3% in the desonide foam group vs 7% in the vehicle foam group; P = .004). LIMITATIONS: The studies evaluated short-term use only. CONCLUSION: Desonide foam was safe and well tolerated in participants as young as 3 months.

Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis.

Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most prevalent in the younger pediatric population and is chronic in nature, safety is of particular concern especially for children under 2 years of age. A novel desonide (0.05%) formulation was developed in a nonirritating and moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. The safety and efficacy of this new class VI low potency topical steroid was substantiated in 2 phase III clinical trials in mild to moderate AD subjects aged 3 months to 18 years (mean age 6.7 years and 30% under 3 years). A total of 425 subjects were treated with desonide hydrogel and 157 subjects with the hydrogel vehicle. Desonide hydrogel 0.05% was extremely well-tolerated and provided statistically significant improvements in all primary (P < .001) and secondary (P < .006) efficacy endpoints in both studies. This novel desonide formulation represents an advancement in the treatment of AD.

Periorbital cutaneous neonatal lupus.

The authors report 3 infant girls with a similar periorbital eruption. A 5-month-old infant girl presented with a 3-month history of a photosensitive facial eruption that had failed to respond to topical 1% hydrocortisone cream. The otherwise healthy infant was the product of a term pregnancy. The 25-year-old mother was in good health except for occasional arthralgias. She had 2 other healthy children. Physical examination revealed a well-developed, well-nourished infant with annular, polycyclic, erythematous scaly plaques involving the cheeks and periorbital region (Figure 1). Potassium hydroxide scraping from the face was negative for dermatophyte and yeast. Laboratory studies revealed normal complete blood cell count, normal liver function tests, strongly positive anti-SSA antibody at 118 units (>80 units, strongly positive), and a negative anti-SSB antibody. Cardiac examination and electrocardiogram (ECG) were also normal. Laboratory evaluation of the mother revealed a positive anti-SSA at 158 units and mild anemia, but anti-SSB, anti-Smith, U1RNP, and anti-Scl-70 antibodies were all negative. Within 4 months the facial eruption cleared completely with the use of desonide cream 0.05% applied twice a day and sun protection. A 6-month-old girl was referred for dermatitis that began on the trunk and face at about 2 months of age. Although the truncal component resolved after 2 months, the facial dermatitis persisted. The infant was in good health and was the first-born child. The mother was known to have Sjögren syndrome. Physical examination revealed the characteristic erythematous, annular, scaling, polycyclic plaques along the forehead, periorbital cheeks, and eyelids (Figure 2). Laboratory evaluation of the infant revealed normal complete blood cell count, liver function tests, and chemistry profile. Anti-SSA antibody was positive at >6 units (reference, <1 unit) and anti-SSB antibody was positive at 2.84 units (reference, <1 unit). U1RNP antibody was negative. Cardiac examination and ECG were normal. The skin abnormalities cleared completely in 6 weeks with the topical application of tacrolimus 0.03% ointment and sun protection. A 5-month-old girl presented with a 2-month history of a persistent facial dermatitis. The infant was in good health and was the product of a healthy first pregnancy and delivery. The mother was in good health. Physical examination of the infant revealed erythematous, annular, polycyclic periorbital patches (Figure 3). Laboratory evaluation revealed positive SSA and SSB antibodies (units unavailable) and normal complete blood cell count, liver function tests, and chemistry profile. Cardiac examination and ECG were normal. The mother's laboratory results were also positive for anti-SSA and anti-SSB antibodies (units unavailable). The infant's facial eruption resolved without specific treatment.

Topical Treatment of Facial Seborrheic Dermatitis: A Systematic Review.

BACKGROUND: Facial seborrheic dermatitis (SD), a chronic inflammatory skin condition, can impact quality of life, and relapses can be frequent. Three broad categories of agents are used to treat SD: antifungal agents, keratolytics, and corticosteroids. Topical therapies are the first line of defense in treating this condition. OBJECTIVE: Our objective was to critically review the published literature on topical treatments for facial SD. METHODS: We searched PubMed, Scopus, Clinicaltrials.gov, MEDLINE, Embase, and Cochrane library databases for original clinical studies evaluating topical treatments for SD. We then conducted both a critical analysis of the selected studies by grading the evidence and a qualitative comparison of results among and within studies. RESULTS: A total of 32 studies were eligible for inclusion, encompassing 18 topical treatments for facial SD. Pimecrolimus, the focus of seven of the 32 eligible studies, was the most commonly studied topical treatment. CONCLUSION: Promiseb®, desonide, mometasone furoate, and pimecrolimus were found to be effective topical treatments for facial SD, as they had the lowest recurrence rate, highest clearance rate, and the lowest severity scores (e.g., erythema, scaling, and pruritus), respectively. Ciclopirox olamine, ketoconazole, lithium (gluconate and succinate), and tacrolimus are also strongly recommended (level A recommendations) topical treatments for facial SD, as they are consistently effective across high-quality trials (randomized controlled trials).

Overview on desonide 0.05%: a clinical safety profile.

Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper provides information on its safety record, as determined from adverse event reports and published trial results. A pharmacovigilance program, initiated in 1992 for all countries where desonide is available, collected reports of adverse events associated with topical desonide over nine years. Published accounts of randomized, controlled trials of desonide in comparison with hydrocortisone were reviewed. Sixty-two reports have been collected; most were from consumers and were not medically substantiated. There were no serious reactions directly attributable to desonide treatment and the majority of events reported were classified as expected local reactions, generally mild in nature. This level of reporting is against a background of extensive prescribing of desonide; almost one million packs are dispensed per annum in the US alone. The excellent safety profile of desonide revealed by this pharmacovigilance program is supported by a review of published clinical trial results.

Effect of desonide ointment, 0.05%, on the hypothalamic-pituitary-adrenal axis of children with atopic dermatitis.

Desonide ointment has demonstrated a good safety and efficacy profile during the many years it has been used in treating dermatoses. However, there have been no controlled clinical trials to evaluate its systemic safety when used in treating children. Suppression of the hypothalamic-pituitary-adrenal (HPA) axis can occur after repeated application of topical corticosteroids. In general, the degree of suppression of the HPA axis function is related to the daily dosage of steroid given, the duration of its administration, the extent of body surface covered, and the potency of the corticosteroid. This study sought to determine the comparative effects of 0.05 percent desonide and 2.5 percent hydrocortisone ointments on the HPA axis of children with atopic dermatitis. There was no suppression of early morning cortisol in either treatment group. The ACTH-stimulated mean cortisol values after four weeks of treatment were not significantly different from the baseline values for either treatment group. We conclude that neither 0.05 percent desonide ointment nor 2.5 percent hydrocortisone ointment compromised the HPA axis of children with atopic dermatitis treated topically for four weeks.