Comparison of mometasone furoate 0.1% cream and hydrocortisone 1.0% cream in the treatment of childhood atopic dermatitis

We conducted a 6-week randomized, blinded study that compared mometasone furoate 0.1% cream, applied once daily, and hydrocortisone 1.0% cream, applied twice daily, in 48 children with moderate to severe atopic dermatitis. Mometasone furoate, a moderate-potency steroid, produced significantly greater improvement than the low-potency hydrocortisone used twice daily. The difference in therapeutic response was particularly evident in patients with involvement of more than 25% of their body surface area. Morning plasma cortisol levels were assayed before treatment, after 1 week of therapy, and at the end of the clinical trial. Plasma cortisol levels were transiently suppressed in one child who was treated with hydrocortisone and in none of the children treated with mometasone.     

Prednicarbate emollient cream 0.1% in pediatric patients with atopic dermatitis

Atopic dermatitis, common among infants and children, is an intensely pruritic, chronic, inflammatory dermatosis that is traditionally treated with emollients for dry skin and topical corticosteroids for inflamed areas. A multicenter, 3-week, open-label study evaluated prednicarbate emollient cream 0.1%, a nonhalogenated midpotency corticosteroid, in 55 patients aged 4 months to 12 years who were diagnosed with atopic dermatitis. No suppression of the hypothalamic-pituitary-adrenal (HPA) axis was evidenced by serum cortisol levels obtained before and after intravenous injection of 250 mg of cosyntropin on days 1 and 22, and biochemical tests detected no other systemic effects. Adverse events were few and within the expected range. Prednicarbate resulted in improvements based on global evaluations and sign/symptom scores. In conclusion, this study found prednicarbate emollient cream 0.1% to be safe and effective for the treatment of atopic dermatitis in pediatric patients for up to 3 weeks.     

Use of adapalene in alopecia areata: Efficacy and safety of mometasone furoate 0.1% cream versus combination of mometasone furoate 0.1% cream and adapalene 0.1% gel in alopecia areata

Alopecia areata (AA) is an autoimmune disease characterized by non‐cicatricial hair loss. No definitive therapy currently exists for AA. To compared the efficacy and safety of the mometasone furoate 0.1% cream alone with the mometasone furoate 0.1% cream plus adapalene 0.1% gel in treatment of AA. Twenty patients with AA and with mean age of 27.4 ± 9.2 years were enrolled. Patches with a diameter of < 5 cm were treated with mometasone furate 0.1% cream (M), and patches with a diameter of ≥5 cm were treated with mometasone furate 0.1% cream plus adapalene 0.1% gel (M + D) for a period of 12 weeks. Hair regrowth was evaluated using a Re‐growth score (RGS). Mean RGSs of M + D group were higher than M group for 4th week (2.60 vs. 1.45); 8th week (3.85 vs. 2.40) and 12th week (4.40 vs. 3.30). Mean percentages of hair re‐growth in M + D group were statistically higher than M group for 4th (50.2% vs. 23.5%), 8th (78.5% vs. 50.7%), and 12th week (90.5% vs. 71%). Study revealed the efficacy and safety of adapalene and mometasone furoate combination in AA. Adapalene can be used as a new therapeutic modality in AA.     

Adherence to clocortolone pivalate cream 0.1% in a pediatric population with atopic dermatitis

Topical corticosteroids are first-line treatments for atopic dermatitis (AD) and their efficacy is well-established in randomized controlled clinical trials. When corticosteroids fail in clinical practice, it often is attributed to nonresponse. However, poor adherence also should be considered. With the advent of electronic monitoring systems, objective data on adherence can be obtained. The purpose of this study was to determine both self-reported and actual adherence to clocortolone pivalate cream 0.1% in the treatment of AD in a pediatric population. Six participants completed the 4-week study. Self-reported adherence was significantly higher than objectively measured adherence (P = .01). In general, adherence was best during the first week of treatment and tapered off thereafter. Clocortolone pivalate cream 0.1% was generally effective, with rapid improvement over the first week of treatment, even when adherence was limited. This study was limited by the small sample size and the failure of 2 participants to complete the study. Patients overestimate their adherence behavior. While some patients are adherent to treatment, others rapidly discontinue their use of medication over time. Midpotency topical corticosteroids such as clocortolone pivalate cream 0.1% are highly effective treatments for AD. Poor adherence should be considered when AD is not responding to topical corticosteroid treatment.     

An open-label adrenal suppression study of 0.1% fluocinonide cream in pediatric patients with atopic dermatitis

OBJECTIVE: To assess the potential of a superhigh-potency 0.1% fluocinonide cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis in pediatric patients with atopic dermatitis. DESIGN: A multicenter, multiple-dose, open-label safety study in 4 age cohorts with 0.1% fluocinonide cream applied once or twice daily for 2 weeks. SETTING: Clinical outpatient setting. PATIENTS: Patients with moderate to severe atopic dermatitis with 20% or more of the body surface area involved were included in the study. Each cohort began only after evaluation of the preceding cohort: ages 12 to younger than 18 years (cohort 1); 6 to younger than 12 years (cohort 2); 2 to younger than 6 years (cohort 3); and 3 months to younger than 2 years (cohort 4). MAIN OUTCOME MEASURES: Assessment of HPA axis suppression, local and systemic adverse events, and change in disease status from baseline. RESULTS: Suppression of the HPA axis was not observed in any patient treated once daily for the 2 youngest cohorts. Suppression was observed in 1 (7%) of 15 and 2 (12%) of 16 patients in the fluocinonide twice-daily group in cohorts 1 and 2, respectively. In all 4 cohorts, more than 90% of patients in the fluocinonide once-daily and twice-daily groups showed improvement in their disease status. CONCLUSIONS: Once-daily treatment with 0.1% fluocinonide cream for 2 weeks does not result in HPA axis suppression under the conditions of this study. Once-daily applications provided similar or better efficacy as twice-daily applications with a lower risk of HPA axis suppression. The frequency of HPA axis suppression is no greater in younger children than in older children. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN71227633.     

Clocortolone pivalate cream 0.1% used concomitantly with tacrolimus ointment 0.1% in atopic dermatitis

This study was designed to evaluate the safety and efficacy of concomitant therapy with the corticosteroid clocortolone pivalate cream 0.1% (Cloderm Cream 0.1%) and the topical immunosuppressive agent tacrolimus ointment 0.1% (Protopic Ointment 0.1%) and to compare each drug alone for the treatment of atopic dermatitis in adolescents and adults. Concomitant therapy may minimize the potential adverse effects of both treatments taken alone and may potentially improve overall response. In this 21-day study with 57 patients with atopic dermatitis, groups of 19 patients were randomized to 1 of 3 treatments: concomitant treatment with clocortolone pivalate cream 0.1% and tacrolimus ointment 0.1% (CPC+ TO), monotherapy with clocortolone pivalate cream 0.1% (CPC), or monotherapy with tacrolimus ointment 0.1% (TO). CPC+ TO was statistically superior to TO alone in the percentage change for dermatologic sum score at days 14 (P = .024) and 21 (P = .033), excoriation at day 21 (P = .028), induration at day 21 (P = .033), and erythema at day 14 (P = .048). The dual therapy was also superior to CPC alone in excoriation at days 7 (P = .045) and 14 (P = .037), oozing or crusting at days 3 (P = .034) and 7 (P = .012), and lichenification at day 3 (P = .031). In addition, unlike the 2 single-therapy treatment groups, percentage reductions from baseline in scores for the sensation of transient pruritus and burning or stinging were statistically significant for the concomitant treatment at days 14 (P = .016) and 21 (P = .016).     

A double-blind trial of treatment of seborrhoeic dermatitis with 2% ketoconazole cream compared with 1% hydrocortisone cream

Fifty patients with seborrhoeic dermatitis were treated with 2% ketoconazole cream (n = 24) or with 1% hydrocortisone cream (n = 26) for 4 weeks in a double-blind comparative study. These twice daily applications resulted in 87.2% symptomatic improvement for hydrocortisone vs. 81.6% for ketoconazole. The number of P. ovale yeasts was significantly reduced after the application of ketoconazole compared with hydrocortisone. The incidence of side-effects was low in both groups.     

Comparative efficacy of hydrocortisone valerate 0.2 percent ointment in the treatment of atopic dermatitis

Evaluations of the comparative efficacy and safety of a newly developed emollient ointment formulation of hydrocortisone valerate 0.2 percent were made in two double-blind, multicenter trials involving 145 patients with atopic dermatitis. Data are presented which indicate that hydrocortisone valerate 0.2 percent ointment is effective in the treatment of mild to moderate atopic dermatitis, has efficacy comparable to that of other intermediate potency corticosteroid ointments, and, moreover, that it is readily accepted by patients.     

Fluticasone propionate 0.05% cream in the treatment of atopic eczema: a multicentre study comparing once-daily treatment and once-daily vehicle cream application versus twice-daily treatment

Summary The aim of this study was to compare the efficacy and safety of once-daily with twice-daily application of a 0.05% cream formulation of fluticasone propionate in the treatment of atopic eczema in adults and children.
Two hundred and seventy patients with moderate to severe atopic eczema were enrolled in the study, and randomized to receive either once-daily or twice-daily fluticasone propionate 0.05% cream for 4 weeks. Patients randomized to the once-daily group also received the vehicle cream to ensure that the study remained blinded. The clinical response of a preselected target area of affected skin was assessed by investigators at weekly intervals, and compared with the baseline. Analysis of the investigators' overall assessment of the response of the target area for both the'intent-to-treat population and the per protocol population showed that 79.85% of patients were judged a clinical success. For both populations, there was no statistically significant difference between the response to once-daily and twice-daily active treatment (intent-to-treat; P= 0.35; 95% confidence interval for difference -14.2 to +5.0 percentage points: per protocol; P = O.42; 95% confidence interval for difference -14.7 to +6.2 percentage points.)
The improvement in the signs and symptoms was judged a success in 95–97% of patients. There was an equal reduction in severity scores for disease activity in both groups, and the speed of symptom relief was similar.
This study shows that a regimen of once-daily application of fluticasone propionate 0.05% cream and once-daily vehicle cream is equivalent in efficacy and safety to twice-daily treatment with fluticasone propionate O.05% cream when used over a 4-week treatment period in patients with moderate to severe atopic eczema.     

The effectiveness of wet wrap dressings using 0.1% mometasone furoate and 0.005% fluticasone proprionate ointments in the treatment of moderate to severe atopic dermatitis in children

Various types of dressings have been used successfully in the treatment of atopic dermatitis. In this study we looked at the efficacy of two of the newer topical steroids when applied under wet wrap dressings for the treatment of refractory atopic dermatitis in children. Forty children with moderate to severe disease were randomized to receive either one-tenth-strength diluted 0.1% mometasone furoate ointment or one-tenth-strength diluted 0.005% fluticasone proprionate ointment. These were applied once a day over a 4-week period without wet wraps, or for 2 weeks without wet wraps followed by 2 weeks of application under wet wraps. There was a 2-week period for all patients when the topical treatment was standardized. At weekly follow-ups, patients were assessed by a single, blinded observer and objectively scored for disease extent and severity. A subjective score was also given for the impact of eczema on daily living. There was significant improvement in the disease severity from baseline during the first 2 weeks of the open application arm (p=0.043), however, additional beneficial effects were limited after week 2. Wet wraps further improved the disease severity and extent after week 2 (p < 0.05), and were well tolerated. We concluded that both 0.1% mometasone furoate and 0.005% fluticasone proprionate ointments are effective in the treatment of atopic dermatitis, and that wet wraps are useful in further improving refractory disease in children.     

An open study of efficacy and safety of long-term treatment with mometasone furoate fatty cream in the treatment of adult patients with atopic dermatitis.

BACKGROUND: Atopic dermatitis is a severe chronic skin disease often deteriorated by the presence of microorganisms and often responds well to treatment with potent corticosteroids. However, the long-term use of potent topical corticosteroids are accompanied by side-effects such as skin atrophy. OBJECTIVE: To study the effect and safety of prophylactic treatment with mometasone furoate fatty cream (contains hexylene glycol) for 6 months in patients with atopic dermatitis. RESULTS: Sixty-one of 68 (90%) patients were still free of their disease after 6 months of twice weekly treatment and only one showed possible treatment related signs of skin atrophy. The number of Staphylococcus aureus and Pityrosporum ovale were significantly reduced in cleared patients. CONCLUSIONS: Mometasone furoate fatty cream is effective and safe both for treatment and as a prophylaxis in patients with atopic dermatitis.     

A pilot study on the efficacy of mometasone furoate fatty cream on clinical parameters, time to relapse and microbial flora in atopic dermatitis

Aim To study the antimicrobial effect in vitro of hexylene glycol and mometasone furoate fatly cream (contains 12% hexylene glycol) and to study the effect of mometasone furoate fatty cream on clinical parameters and microbial flora in patients with atopic dermatitis. Methods The effect of hexylene glycol and mometasone furoate fatty cream against Staphylococcus aureus, S. epidermidis, Pityrosporum ovule and Candida albicans was studied in vitro. Twenty patients with moderate to severe atopic dermatitis were treated with mometasone furoate 0.1 % fatty cream once daily for 3 weeks and then intermittently for 3 weeks. Quantitative cultures for bacteria and fungi were taken at baseline, during treatment and 4 weeks after end of treatment. Results Both hexylene glycol and mometasone furoate fatty cream were effective in vitro against the studied microorganisms. Thirteen of 18 patients who returned for control were cleared after 3 weeks of treatment and 15/18 patients or 83% were cleared after 6 weeks. Four weeks after end of treatment only one patient remained cleared. However, 11/14 patients who returned for this control were still improved compared to baseline. S aureus was cultured in 16/20 patients at baseline but in only 7/18 patients after 6 weeks of treatment. The number of S. aureus dropped significantly but increased two-fold 4 weeks after end of treatment. The number of cultured P. ovale was also significantly reduced after 6 weeks. Conclusion This study clearly demonstrate the good effect of mometasone furoate fatty cream, which contains 12% hexylene glycol, in the treatment of atopic dermatitis paralleled by a significant reduction in the number of S. aureus and P. ovale.     

Evaluation of adrenal suppression of a lipid enhanced, topical emollient cream formulation of hydrocortisone butyrate 0.1% in treating children with atopic dermatitis

Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety concern. Twenty boys and girls, 5-12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% for up to 4 weeks. At the conclusion of the 4-week treatment period, cosyntropin injection stimulation testing showed no evidence of adrenal suppression. In addition, the therapy was noted to be highly efficacious, with a clinical success rate of 80% (Physician Global Score of (0) clear or (1) almost clear). No local side effects associated with prolonged use of topical corticosteroids were reported. In summary, this study supports the contention that this lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% was a well-tolerated and beneficial treatment for atopic dermatitis, demonstrating no adrenal suppression in the pediatric population aged 5-12 years. The relevance of these findings for children below 5 years of age, because of difference in body mass/surface area ratios, remains to be determined.     

Topical tacrolimus 0.1% ointment (protopic) reverses nickel contact dermatitis elicited by allergen challenge to a similar degree to mometasone furoate 0.1% with greater suppression of late erythema

The aim of this study was to evaluate the ability of topical tacrolimus 0.1% under occlusion for 48 h to suppress nickel-elicited allergic contact dermatitis in a randomized, petrolatum- and mometasone furoate 0.1% ointment-controlled double-blind, intra-individual study which included 28 women volunteers. 3 closed patch tests (Finn Chambers on Scanpor, Epitest Ltd Oy, Tuusula, Finland) containing 0.1 ml of 5% nickel sulfate in petrolatum were applied on day 0. After removal on day 2, the study compounds were applied under occlusion for 48 h. The eczema reaction and the degree of erythema were evaluated clinically and by reflectance spectrophotometry at days 4 and 7, respectively. Mean visual scores corresponding to petrolatum-treated sites were significantly higher than those corresponding to both mometasone furoate and tacrolimus at days 4 (P < 0.001) and 7 (P < 0.001). In both tacrolimus- and mometasone furoate-treated sites, there was a significant decrease in visual scores with time (P < 0.001) from day 2 to day 7, and the corresponding mean decreases in scores were 0.73 and 1.04, respectively. The difference between both was 0.30 in favour of tacrolimus (95% confidence intervals, -0.04 and 0.65), although this did not reach statistical significance (P = 0.084). Mean erythema index values were similar at day 2. Significant differences among treatment sites were seen at days 4 (P < 0.001) and 7 (P < 0.001). The decrease was significantly more pronounced on day 7 in patches where tacrolimus had been supplied (P < 0.5). This method might provide useful means to compare different concentrations and/or presentations of tacrolimus or other calcineurin inhibitors and topical anti-inflammatory agents.     

Improvement in treatment adherence with a 3-day course of fluocinonide cream 0.1% for atopic dermatitis

Variations in adherence may cause variations in treatment outcomes with topical corticosteroid therapy for atopic dermatitis. An intensive short course of outpatient treatment may promote good adherence and provide a high level of efficacy. The purpose of this study was to assess the efficacy, tolerability, and adherence to short-term treatment with fluocinonide cream 0.1% in the treatment of atopic dermatitis. Twenty participants with mild to severe atopic dermatitis were instructed to use fluocinonide cream 0.1% twice daily for 3 consecutive days for a total of 6 doses. Disease severity was assessed at baseline, day 3, day 7, and day 14. Electronic monitoring was used to measure adherence to treatment. Median adherence to treatment over the 3-day period was 100%. By day 14, the median visual analog scale (VAS) of pruritus and eczema area and severity index (EASI) scores improved from baseline by 79% and 76%, respectively. By the end of the study period, 11 participants had investigator global assessment (IGA) scores of clear or almost clear. The absolute degree of improvement was proportional to baseline disease severity. Short-term treatment with fluocinonide cream 0.1% for atopic dermatitis was well-tolerated and resulted in significant disease improvement (P < .001). Participants were highly adherent to the 3-day treatment regimen. Efforts to improve adherence may be valuable approaches for treating recalcitrant atopic dermatitis.     

Evaluation of the atrophogenic potential of hydrocortisone 1% cream and pimecrolimus 1% cream in uninvolved forehead skin of patients with atopic dermatitis using optical coherence tomography

Topical corticosteroids are widely used to treat atopic dermatitis (AD), but their anti‐inflammatory mode of action can be accompanied by several unwanted side effects including skin atrophy and telangiectasia. In this 8‐week, investigator‐blinded, intraindividual right‐left comparison study with patients with mild‐to‐moderate AD, hydrocortisone 1% cream (HCT) was applied twice daily for 4 weeks on one side of forehead skin without clinical signs of AD and pimecrolimus 1% cream (PIM) on the other. Epidermal and dermal thickness were assessed by optical coherence tomography (OCT) and high‐frequency ultrasound, respectively. Skin atrophy and telangiectasia were assessed by contact dermatoscopic photography (Dermaphot^®). Treatment with HCT leads to a significant decrease in epidermal thickness after only 2 weeks of treatment, while the decrease in PIM‐treated sites was less pronounced and was not statistically significant. By 4 weeks after the end of treatment, epidermal thickness returned to baseline values. No dermal thinning or development of telangiectasia could be observed by means of ultrasound or Dermaphot^®, respectively. In summary, this study indicates that a 2‐week single course of topical treatment with a mildly potent steroid can cause transient epidermal thinning, an effect not seen in the PIM group. The slight decrease with PIM – although not significant – could be due to normalization of the increased skin thickness caused by a subclinical inflammation in AD. This study suggests that PIM may be safer for treatment of AD in sensitive skin areas like the face, especially when repeated application is required.     

A new formulation of 0.1% hydrocortisone cream with vasoconstrictor activity and clinical effectiveness

A new formulation of hydrocortisone with vasoconstrictor activity has been shown to be effective clinically and was more effective in a 0.1% concentration than 1.0% Hydrocortisone Cream BPC. Its use should obviate the adverse effects of fluorinated steroids.