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Medical device repairing emollient creams (MDRECs) are designed to repair and protect the skin barrier. In this study, we examined the added clinical benefit and tolerability of a MDREC when used in association with a moderately potent topical corticosteroid (TCS) for adults with atopic dermatitis (AD). This was an intra-individual randomized controlled trial in adults with moderate to severe AD (EudraCT no. 2014-002,194-10). Symmetrical lesions on each arm of the subjects were randomized to treatment for 10 days with twice-daily TCS (desonide) cream alone or with combined TCS + MDREC. Subjects were then included in a following 2-week maintenance phase if the AD on at least one test area had sufficiently improved so that the treatment was no longer needed. During the maintenance phase, treatment with the TCS cream was stopped, but twice-daily application of the MDREC was continued on the same test area previously assigned to receive it. The primary outcome measure was the change in local Scoring Atopic Dermatitis (SCORAD) index between day 1 and 3 based on investigators’ assessment. Secondary measures of lesion severity included changes in the local patient-oriented SCORAD index, pruritus intensity according to subjects’ assessments, and global assessments by subjects and investigators. The study included 54 subjects. The change in investigator-observed local SCORAD index between day 1 and 3 was − 14.4% with TCS alone and − 24.5% for TCS + MDREC (p = 0.0005). Between baseline and the end of the treatment phase, all secondary measures of lesion severity decreased more with the combined TCS + MDREC treatment than with the TCS cream alone. The MDREC also reduced the relapse of AD lesions during the maintenance phase. Tolerability was very good, and the product was well accepted by subjects. These results support using the MDREC in association with TCS during AD flares and as a maintenance therapy after treatment with TCS has stopped. Laboratoires Dermatologiques Ducray, Pierre Fabre.

In order to investigate the effect of daily emollient treatment on infantile atopic dermatitis (AD) during the maintenance period, a total of 309 children younger than 2 years with moderate AD (155 and 154 in the treatment and control groups, respectively) were enrolled in this multicenter, randomized, parallel controlled clinical trial. Subjects were topically treated with desonide cream and emollients in Prinsepia utilis Royle for 2-4 weeks before entering the maintenance period and then differentially treated with either emollients for treatment or none for control. The cumulative maintenance rate, time to flare and improvement of eczema area and severity index (EASI) and infant's dermatitis quality of life index (IDQOL) were evaluated. Results showed that the cumulative maintenance rate of the treatment group (60.5%, 95% CI 50.0-69.4%) was significantly higher than that of the control group (23.5%, 95% CI 15.2-33.0%) (p < .001). The median time to flare in the treatment group was 90 days (interquartile range, IQR 28-90), which was significantly longer than that in the control group (28 days [IQR 18-67]) (p < .001). At Week 4 in the maintenance period, the EASI and IDQOL scores of the treatment group were lower than those of the control group. In conclusion, the application of emollients during the maintenance period of infantile AD can significantly reduce the risk of AD flares, prolong the time to flare and improve the clinical symptoms.

We report two pediatric patients with a history of chronic lichenified atopic dermatitis (AD) who subsequently developed eruptive lentigines at sites of resolved AD. The occurrence of this phenomenon in eczematous dermatoses in the absence of topical calcineurin inhibitor (TCI) use is rarely reported in the literature.

Corticosteroids are first-line therapies for the treatment of many inflammatory dermatoses, including atopic dermatitis, contact dermatitis, psoriasis and seborrheic dermatitis. Desonide, a low-potency corticosteroid, has been formulated in a moisturizing hydrogel that has been US FDA approved for mild-to-moderate atopic dermatitis in patients as young as 3 months of age. This new formulation represents a safe and effective option for atopic dermatitis patients and provides the benefits of a novel hydrogel vehicle that is both a well-tolerated and a cosmetically elegant alternative to traditional vehicles.

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.

Summary A double-blind, randomized trial was conducted to determine the influence of topical steroid therapy on atopic skin flora. The bacteriological and clinical effects of desonide (Locapred®), compared with those of its excipient, were studied in 40 children. Clinical scoring and bacteriological sampling were performed before the start of the trial and after 7 days of once-daily topical treatment. Before treatment, no differences in clinical score or Staphylococcus aureus colonization were noted between the two groups. After treatment, the clinical score improved (P

The differences between topical corticosteroids are based mainly on their potency, safety and patient acceptability. The aim of this study was to evaluate a mild- to mid-potent topical corticosteroid, desonide 0.05%, on these three parameters in an Australian cohort of patients with facial seborrhoeic or atopic dermatitis. Eighty-one adult patients were randomized to receive desonide 0.05% lotion or its vehicle, applied twice daily for 3 weeks under double-blind conditions. In the active treatment group, 88% of patients had their skin condition cleared or almost cleared and only two patients experienced cutaneous adverse events (rash and pruritus). The acceptability of the lotion was high; 95% of patients stated they would use this topical corticosteroid again. These data support the short-term use of desonide 0.05% lotion as a suitable agent for the short-term treatment of facial dermatitis.

Dear Editor: The acidic pH of the stratum corneum (SC) is important to the protective functions of the skin, including permeability barrier homeostasis1,2, SC integrity and cohesion1,2, antimicrobial defense2,3, and primary cytokine activation. The pH of the SC increases in inflamed skin4 such as in atopic dermatitis (AD). Therefore, the reversal of pH abnormality may be a possible preventive or therapeutic strategy for these problems5. Acidification of the SC improves permeability barrier homeostasis by increasing the activity of the two key ceramide-generating enzymes such as β-glucocerebrosidase and acidic sphingomyelinase6, and reinforces SC integrity and cohesion by decreasing the activity of serine proteases. Many alternative treatment modalities have been suggested for refractory AD. In Japan, bathing in acidic hot spring water is one of the treatment options for refractory AD. Acidic water has been known to have an antibacterial effect against Staphylococcus aureus, which densely colonize in the eczematous skin of AD7. We conducted a clinical study in patients with refractory AD by using acidic water bathing. We compared the efficacy of acidic water bathing to that of wet-wrap dressing which has already been shown to be highly effective for severe or refractory AD3,8. The experiment was performed after obtaining approval from the Institutional Review Board (2011-49) of Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine. Eighteen patients with AD were recruited. Their eczema area and severity index (EASI) scores ranged from 11.4 to 59.6 (mean±standard deviation, 26.9±12.7). All patients had refractory AD that required long-term maintainence with cyclosporine to control their atopic eczema. Eight patients (positive control group) were treated with wet-wrap dressing and ten patients (treatment group) were treated with acidic water bathing (Table 1). The mean EASI scores of the wet-wrap dressing group and the acidic water bathing group were 28.69 and 25.36, respectively. No statistical difference was observed (p-value=0.67). Table 1 Summary of atopic dermatitis patients Patients in the acidic water bathing group were instructed to take a 40-minute warm bath with a pH of 3.0 twice daily for 2 days, pat with a towel, and thoroughly apply moisturizers immediately after getting out of the bath. The acidic water was made by dissolving citric acid (Fuso Chemical Co., Qingdao, China) in tap water until the bath water had a pH of 3.0. The wet-wrap dressing group took a 5-minute tepid bath or shower, applied moisturizer (Cellbrick; Barummedi, Seoul, Korea) thoroughly on the whole body after patting gently, and wore clinging wet dressings soaked with warm and clean water with a raincoat over the dressings. For the first and/or second treatment, 1:3 diluted topical 0.05% desonide lotion (Desowen; Galderma Pharma SA, Lausanne, Switzerland) and moisturizer were used. For the third and fourth treatments, only moisturizer was used. After 40 minutes, the patients took off the wet dressings and applied moisturizer again. Both patient groups were told not to use any additional medications other than the moisturizers and corticosteroids used in the treatment. Every patient filled in a questionnaire and was given an EASI score on the first visit. To evaluate epidermal permeability barrier function, basal transepidermal water loss (TEWL) and SC hydration (SCH) were measured with a Tewameter (Courage & Khazaka, Cologne, Germany), and a Corneometer (Courage & Khazaka) from lesion-free and lesional sites at the patients' forearms before and after each treatment. Skin evaluation was performed 12 hours after the last treatment. On the third day, 12 hours after the end of 4 sessions of treatments, the patients were asked about their satisfaction and any side effects. Improvement of EASI score, referred to as Δ EASI, was compared between the acidic water bathing group and the wet-wrap dressing group. The Δ EASI of the group treated with acidic water bathing was over 30%. There was no difference compared to the group treated with wet-wrap dressing (Fig. 1). The effect of acidic water bathing on epidermal permeability barrier function was assessed by comparing Δ TEWL and Δ SC hydration measured from the lesion-free skin and lesional skin of the patients in each group. No significant differences were found in non-lesional skin or lesional skin between the two groups (Fig. 2). The satisfaction of patients in the acid water bathing group was nearly the same as that of patients in the wet-wrap dressing group. No side effects were reported except for an initial, rapidly subsiding, and mild tingling sensation in two patients in the acidic water bathing group. Recently, the efficacy of SC acidification in the treatment of developmentally impaired skin has been studied. Hyper-acidification was revealed to normalize the impaired barrier function of neonatal and aged human and rodent skin in which SC acidification was impaired. Maintenance of SC acidity by topical acidic application was demonstrated to prevent the emergence of AD9 and even the occurrence of respiratory allergic inflammation10. In Japan, bathing in acidic hot springs (around pH 2.5) located near a dormant volcano is known to be effective for severe or refractory AD. However, Korea has no hot water springs. To mimic the effects of these hot springs for patients with AD, we used artificially acidified water, which costs a small amount. Improvements of the eczema lesions measured by EASI scores and the permeability barrier function measured by TEWL and SC hydration were not significantly different between patients with AD treated with acidic water bathing and those treated with wet-wrap dressing, the latter being an already widely accepted treatment for refractory AD. Patient satisfaction with the two treatments was similar, and side effects were negligible. Fig. 1 The improvement in eczema area and severity index (EASI) score indicated by Δ EASI (%) in the patient group treated with acidic water bathing was not significantly different from that seen in the wet-wrap dressing group. Results are shown as the ... Fig. 2 Improvement in skin barrier function indicated by Δ TEWL (%) and Δ SCH (%) in the acidic water bathing group was comparable to that in the wet-wrap dressing group. There were no differences between the two groups in either lesion-free ... The present clinical experiments in humans showed that acidic water bathing was as effective for severe or refractory AD as was wet-wrap dressing. However, we could not select subjects by age because of the limited number of enrolled patients. Furthermore, a blind study could not be performed. We surmise that acidic water bathing can be an alternative and safe therapeutic modality for severe or refractory AD.

Topical steroids are used for the treatment of primary atopic dermatitis (AD); however, their associated risk of serious complications is great due to the presence of vulnerable lesions in young children with AD. Topical calcineurin inhibitors (TCIs) are steroid-free, anti-inflammatory agents used for topical AD therapy. However, their use is prohibited in infants

Treatment goals for atopic dermatitis consist of attempting to eliminate inflammation and infection, hydrating the skin, controlling pruritus, and avoiding exacerbative factors. The aim of this study was to evaluate the effects of adding a moisturizing regimen to a low-potency topical corticosteroid lotion regimen in the treatment of atopic dermatitis. This controlled, randomized, investigator-masked 3-week study was undertaken to compare twice-daily applications of desonide lotion 0.05% alone with twice-daily applications of desonide lotion 0.05% plus three-times-daily applications of a moisturizing cream. The efficacy variables assessed included erythema, dryness or scaling, pruritus, excoriations, lichenification, oozing or crusting, and induration or papules. Administration of desonide lotion alone created statistically significant improvement in total sign and symptom scores. The addition of a moisturizer to the treatment regimen produced additional statistically significant improvement in total sign and symptom scores, physicians' global assessments of improvement, and most of the individual efficacy variables. Results of this study suggest that the addition of a moisturizer to a low-potency corticosteroid lotion in separate regimens was effective in treating the signs and symptoms of mild-to-moderate atopic dermatitis.

Hand, foot, and mouth disease (HFMD) is a common childhood viral illness characterized by vesicles in the mouth, hands, feet, and sometimes the buttocks. HFMD has a predilection for the summer and autumn seasons, and historically has been treated with supportive care. Coxsackievirus A16 and enterovirus 71 are the most commonly reported viruses responsible for HFMD. Coxsackievirus A6 (CVA6), however, has been associated with more widespread skin lesions and profound tissue destruction. Recently, the term eczema coxsackium (EC) was coined to describe patients with underlying atopic dermatitis who present with an eczema herpeticum-like eruption caused by CVA6 with vesicles and erosions in pre-existing areas of eczema. Enteroviral infections, particularly CVA6, should be on the clinicians’ differential diagnosis of children who present with extensive erosions and vesicles, and with a history of eczema. We present the first case, to our knowledge, that documents wet wrap therapy (WWT) as a viable treatment option for CVA6 EC, a condition that previously has only been treated with supportive measures. Our patients were 8-month-old former 36-week fraternal twin boys with medical histories significant for eczema. A few days before their January admission, the eczema of both patients were noted to be worsening and not responding to step-up therapy. The primary care physician had escalated therapy from daily moisturizing, as needed over-the-counter class VII topical corticosteroids (TCS), and twice a week diluted bleach baths, to a class V TCS, Hydrocortisone Valerate 0.2% cream (Perrigo Pharmaceuticals, Bronx, New York, New York). The patients were presented to the emergency department with rapid progression of a vesiculobullous rash that involved the face, particularly the perioral area, upper and lower extremities, and trunk. Of note, twin B was diagnosed with otitis media on the day before presentation to the hospital, for which his pediatrician started him on cefdinir. The infants were referred for admission because of worsening skin lesions, fussiness, and dehydration. Laboratory evaluation included a complete blood cell count with differential, comprehensive metabolic panel, and blood cultures. Vesicular fluid was aspirated and sent for herpes PCR, enterovirus PCR, and viral cultures. Intravenous acyclovir and ceftriaxone were started for empiric treatment of herpes and possible bacterial superinfection. Differential diagnosis included eczema herpeticum, varicella, EC from HFMD, and a severe eczema flare with secondary bacterial infection. Complete blood cell count and comprehensive metabolic panel results were within normal limits. Results of herpes PCR, viral cultures, and blood cultures were negative. The enteroviral PCR results were positive. Further testing by the Centers for Disease Control and Prevention confirmed CVA6. Ceftriaxone and acyclovir were stopped when blood cultures and erpes simplex virus PCR results were negative, and WWT and low-potency Class VI TCS (desonide 0.05% ointment, Taro Pharmaceuticals Inc., Brampton, Ontario, Canada) were started. Although it is well known that WWT, in conjunction with TCS, is an effective and safe treatment for severe flares of atopic dermatitis refractory to increased TCS strength, to our knowledge there is no literature that mentions the use of WWT for treatment of EC. The benefits of WWT include an occlusive barrier that prevents scratch-induced skin trauma, increased skin hydration, decreased pruritus and inflammation by cooling of the skin, and increased penetration of the TCS. Complications, such as maceration of the skin or secondary skin infections, are possible but have been shown to be uncommon with proper application of WWT. Because standard skin therapy was unsuccessful for these patients before admission and because results of enteroviral PCR were positive, which raised our suspicion that this was a possible EC case, we considered the risks and benefits of increasing the potency of the TCS further, commensurate with the severity of the flare, versus implementing WWT with a low-potency TCS. Although there have been no reported complications with patients with CVA6 EC, there are no studies that evaluated whether the use of TCS, or occlusion from WWT, increases the risk of complication. Furthermore, there are no studies that evaluated whether the use of TCS, or occlusion from WWT, increases the risk of worsening the cutaneous findings of EC by immunosuppression and leads to more disseminated viral growth. When considering the large body surface area involved, and balancing the uncertainty of the theoretical risks of higher-potency corticosteroids inCVA6ECwith the knownbenefits ofWWTand TCS, we chose to continue treatment with a low-potency TCS with the addition of WWT. Systemic adverse effects from WWT with corticosteroid use were considered; however, prolonged suppression of the hypothalamic-pituitary-adrenal axis has not been reported after short-term treatment with WWT and TCS. Therefore, we pursued only short-term use of combined WWT and low-dose TCS for 3 days. Wet wraps were applied 3 times a day, with the morning and evening wraps to include Aquafor (Beiersdorf, Hamburg, Germany) to unaffected areas and desonide 0.05% ointment to the affected areas, and the mid day wrap included Aquafor head to toe. The morning and mid day wraps wereworn for an hour, and the eveningwrapswereworn overnight. Within 24 hours, the patients demonstrated significant clinical improvement, and were discharged after extensive family education to continue the same WWT regimen at home. Twin B also was discharged on cefdinir for the previously diagnosed otitis media. By day 3 after discharge, the patients had improved dramatically, and WWT was discontinued. The twins were seen for follow-up 5 days after discharge and were noted to have had an

Desonide, a low potency corticosteroid, has been used widely as a topical treatment for inflammatory dermatoses for over 30 years. A recent formulation advance has enabled the development of desonide 0.05% into a novel moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. This multicenter, open-label study evaluated the hypothalamic-pituitary-adrenal axis suppression potential, tolerability, and efficacy of this new Class VI topical steroid formulation in pediatric subjects with moderate-to-severe atopic dermatitis (mean body surface area = 51%). Forty children, aged 6 months to 6 years were enrolled and treated twice daily for 4 weeks. Desonide hydrogel 0.05% was well tolerated and no treatment-related adverse events were reported. No suppression of adrenal function was observed in subjects who completed the study without protocol violations related to cosyntropin administration or cortisol testing (n=34). Of the subjects who completed the study with complications in cortisol testing (n=3), there was one subject (1/37=3%) who had a low poststimulation cortisol level at week 4. Efficacy was demonstrated by marked improvement in overall disease state and in the signs and symptoms of atopic dermatitis. This study validates the systemic safety of a novel desonide hydrogel formulation in young pediatric patients and confirms the longstanding tolerability and efficacy profile of desonide.

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.

Background: Desonide, a class 6 nonfluorinated topical corticosteroid, has been available for more than two decades. Hydrocortisone is widely used in the treatment of dermatoses in children. Objective: Our purpose was to compare the safety and efficacy of desonide ointment and 1.0% hydrocortisone ointment in children with atopic dermatitis. Methods: One hundred thirteen children (mean age, 4.8 years) with mild to moderate atopic dermatitis were enrolled in a multicenter, randomized, investigator-masked, parallel-group study. Treatments were applied twice daily for 5 weeks and extended to 6 months in 36 of the patients. Signs of atrophy were evaluated. Efficacy was determined by measuring global improvement, erythema, lichenification, excoriations, oozing or crusting, pruritus, and induration. Results: No differences in safety were observed between hydrocortisone and desonide. The investigator's global assessment of improvement significantly favored desonide over hydrocortisone during 3 months of treatment ( p Conclusion: Desonide ointment showed greater efficacy, produced more rapid improvement, and demonstrated an equivalent cutaneous safety profile when compared with 1% hydrocortisone ointment for up to 6 months.

Desonide foam is a newly approved topical corticosteroid preparation of 0.05% desonide. It has been shown effective compared with vehicle placebo in the treatment of mild-to-moderate atopic dermatitis in both pediatric and adult populations. Given the favorable safety profile of all other desonide preparations and their utility as a low potency corticosteroid, desonide foam promises to be a useful addition to the armamentarium, when other desonide vehicles might be less acceptable.

Six groups of children suffering from widespread atopic dermatitis were treated once daily with six topical steroids of different potency. Systemic effects were measured by the morning estimation of plasma cortisol. A clear relationship was demonstrated between clinical efficacy of the steroid treatment and degree of reduced adrenal function. This study demonstrated that a rapid and marked therapeutic effect can be obtained with potent topical steroids applied once daily without occlusion, but in children is accompanied by a fall in plasma cortisol.

A randomized, double-blind, left-right study to compare the therapeutic efficacy and the cosmetic acceptability of the new hydrocortisone 17-butyrate (Locoid®) 0·1% fatty cream application form with desonide (Apolar®) 0·1% ointment was performed in thirty patients suffering from moderate to severe atopic dermatitis. The medications were applied to symmetrical, bilateral skin lesions twice daily for 4 weeks. Both treatments effected highly significant reductions of the score values for the severity of all clinical skin parameters assessed. Score reductions were, however, more pronounced on Locoid-treated sides than on Apolar-treated sides both after 2 and 4 weeks of therapy. It appeared further that clinical efficacy of treatment at completion of the study was also in favour of Locoid-treated sides, indicating that Locoid fatty cream is more effective than Apolar ointment. No serious side-effects were reported during the study. The expressed patient preferences with respect to cosmetic acceptability of treatments were significantly in favour of Locoid fatty cream, indicating that patients preferred the use of this new galenic formulation over an ointment formulation. It is concluded that the new application form of Locoid, a fatty cream, is a useful and beneficial addition to topical corticosteroid therapy, which will promote patient compliance in a wide range of corticosteroid-responsive skin diseases.