Biophysical assessment of atopic dermatitis skin and effects of a moisturizer

BACKGROUND: The mechanisms of the skin barrier impairment in patients with atopic dermatitis (AD) are still unknown and need further studying. OBJECTIVE: We evaluated the skin of healthy subjects and of patients having atopic dermatitis with an instrument measuring electrical impedance and other noninvasive methods (transepidermal water loss, capacitance) and studied the effects of a new emollient [Proderm (Pro-Q in the USA)]. METHODS: After a 2-week washout period, we treated clinically noneczematous skin on the forearm of 24 patients with AD and assessed the effects with the noninvasive methods. 22 healthy subjects were used as controls. RESULTS: The findings indicate that barrier function and hydration, and certain patterns of electrical impedance of AD skin are abnormal compared with normal skin. Moreover, there was an increase in hydration in patients' skin after treatment and a reversal of certain impedance indices towards normal. CONCLUSIONS: Our findings demonstrate that the moisturizer we used changes some biophysical parameters when applied to atopic skin. In addition, a technique based on electrical impedance seems to give valuable information in atopic skin studies, especially the effects of moisturizers.     

A double-blind study of tolerance and efficacy of a new urea-containing moisturizer in patients with atopic dermatitis

Background  Atopic dermatitis patients almost all use moisturizers to prevent and treat their skin disease. However, the safety and efficacy of moisturizers are rarely studied in this patient population.
Aims  To evaluate the efficacy and tolerability of urea-containing moisturizers in subjects with atopic dermatitis.
Methods  One hundred subjects with atopic dermatitis were randomized to apply either a new 5% urea moisturizer or a commercially available 10% urea lotion twice a day for 42 days. Scoring Atopic Dermatitis severity index (SCORAD) was performed at Day 0 and Day 42. Cosmetic acceptability questionnaires, adverse events, and a 5-point tolerance evaluation were administered or performed at Day 42.
Results  Both study products were very well tolerated by subjects and only three subjects discontinued their participation in the study due to adverse events. Mean SCORAD significantly decreased between Day 0 and Day 42 by 19.76% and 19.23%, respectively, for subjects treated with the new 5% urea moisturizer or the 10% urea lotion ( P  < 0.001). There was no difference between the two products in SCORAD reduction; however, significantly more subjects preferred using the new 5% urea moisturizer as compared with the 10% urea lotion.
Conclusions  Both the new 5% urea moisturizer and the 10% urea lotion improved atopic dermatitis and were very well tolerated. However, the cosmetic acceptability questionnaire showed that subjects preferred using the new 5% urea moisturizer over the 10% urea lotion.     

The steroid-sparing effect of an emollient therapy in infants with atopic dermatitis: a randomized controlled study

BACKGROUND: No study has clearly demonstrated the steroid-sparing effect of emollients in the treatment of atopic dermatitis (AD). AIM: Evaluating the effect of an emollient containing oat extracts on the amount of topical corticosteroids used in infants with moderate to severe AD. STUDY DESIGN: During 6 weeks, 173 infants under 12 months old treated for inflammatory lesions by moderate- and/or high-potency topical corticosteroids randomly received the emollient or not (control group). METHODS: Evaluation of corticosteroid consumption by weighing the tubes, disease severity by the Scoring Atopic Dermatitis Index (SCORAD), and infants' and parents' quality of life by Infant's Dermatitis Quality of Life Index and Dermatitis Family Impact scores at D0, D21 and D42. RESULTS: Compared to the control group, the amount of moderate- and high-potency corticosteroids used in 6 weeks decreased by 7.5% (not significant) and 42% (p < 0.05), respectively, in the emollient group. The SCORAD index, and infants' and parents' quality of life significantly improved (p < 0.0001) in both groups. CONCLUSION: The emollient treatment significantly reduced the high-potency topical corticosteroid consumption in infants with AD.     

Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study

Background Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2 years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2 years at start of treatment. Methods Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24‐month open‐label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment. Results Mean ± SD Eczema Area and Severity Index (EASI) score improved, from 11.2 ± 10.5 baseline to 2.6 ± 4.1 at endpoint (24 months); mean affected body surface area decreased from 25.2 ± 21.1% to 5.1 ± 9.0%, with improvement on all items of the Physicians’ Assessment of Individual Signs. The Physicians’ Global Evaluation of Clinical Response showed a result of “cleared”/“excellent” for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as “much better.” Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application‐site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0 ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250 ng/ml). Conclusions Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.     

Blood concentrations, tolerability and efficacy of pimecrolimus cream 1% in Japanese infants and children with atopic dermatitis

Pimecrolimus cream 1% is a topical calcineurin inhibitor for the treatment of atopic dermatitis. Minimal systemic exposure to pimecrolimus has been previously observed in Caucasian pediatric patients treated with the cream twice daily for up to 1 year. The objective of this open-label, non-comparative, multicenter study was to assess the systemic exposure, tolerability and efficacy of pimecrolimus cream 1% when used twice daily for 3 weeks in pediatric patients of Japanese background. The patient cohort consisted of 17 Japanese infants and children (age range, 3.6 months to 11.6 years) with atopic dermatitis of at least mild severity affecting >or=10% of the total body surface area (range, 10-48%). Pimecrolimus cream 1% was applied twice daily for 3 weeks. Blood levels of pimecrolimus were determined on days 1, 10 and 22. Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, physical condition and vital signs. Efficacy parameters included the Eczema Area and Severity Index, the Investigators' Global Assessment and the pruritus score. The median exposure to pimecrolimus cream 1% was 22 treatment days (range, 9-29 treatment days). Pimecrolimus blood concentrations were <0.5 ng/mL in 94% of samples on day 1, in 93% of samples on day 10 and in 100% of samples on day 22, with no indication of an increase with increasing body surface area treated (up to 48% of the total body surface area). No drug-related systemic adverse events or serious adverse events were reported. Treatment was effective according to all efficacy parameters. The findings of this study indicate that the use of pimecrolimus cream 1% results in minimal systemic absorption of the active ingredient in pediatric patients of Japanese background with extensive disease.     

Comparative trial of moisturizer containing licochalcone A vs. hydrocortisone lotion in the treatment of childhood atopic dermatitis: a pilot study

Background Although moisturizer usage has been considered a mainstay of treatment for atopic dermatitis (AD) patients, few clinical studies have been investigated. Recently, moisturizers containing non‐steroidal anti‐inflammatory agents, such as licochalcone A (LA) and vitamin B₁₂ are of emerging interest. Objective To compare the effectiveness of moisturizer containing LA with hydrocortisone (HC) lotion in treatment of childhood AD. Methods The randomized, controlled, investigator‐blinded 6‐week study was conducted. Patients were administered with twice‐daily application of LA lotion on one side of the body and HC lotion on the opposite side. The clinical outcome was assessed by the scoring of atopic dermatitis (SCORAD) index. The relapse rate was comparatively analysed by survival analysis. Results From 30 patients enrolled, 26 patients completed the protocol. The mean age of the children was 5.8 years. The average baseline SCORAD score is about 28 on both sides. The response rates of both agents were equal to 73.33%. There is no statistical significant group difference in reduction of SCORAD score. Although we observed more rapid resolution of oedema and erythema in areas treated with HC lotion, both agents exhibited no significant difference. The relapse rate of HC group was higher than in LA group; however, there was no significant difference. No side‐effect was observed from both agents. Conclusion The effectiveness of LA lotion is equal to that of HC lotion. It was suggested that moisturizer containing LA could be used both for treatment of acute and maintenance phase in mild‐to‐moderate childhood AD.     

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.     

A randomized half-body,double blind,controlled trial on the effects of a pH-modified moisturizer vs. standard moisturizer in mild to moderate atopic dermatitis

BackgroundHigher skin pH in atopic dermatitis contributes to impaired epidermal barrier. A moisturizer compatible with physiological pH could improve atopic dermatitis.ObjectiveTo determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.MethodsA randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.ResultsA total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p = 0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p = 0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p = 0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p = 0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p = 0.046). SCORAD improved from 14.1 ± 12.75 to 10.5 ± 13.25 to 7 ± 12.25, p = 0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p = 0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p = 0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p = 0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p = 0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p = 0.80). SCORAD improved from 14.2 ± 9.1 to 10.9 ± 10.65 to 10.5 ± 11, p = 0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.Study limitationSkin hydration was not evaluated.ConclusionMoisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.     

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

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Open-label,single-arm,single-center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol-rich composition in children with mild to moderate atopic dermatitis

Background

Little is known about antioxidant efficacy of topical vitamin E on atopic dermatitis (AD) due to lack of controlled clinical studies.

Aim

The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.

Methods

We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).

Results

Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p < 0.05). There was also a significant decreased in pruritus intensity (46%, p < 0.05). Similarly at week-12, Infant's Dermatitis Quality of Life Index and Children's Dermatology Life Quality Index were found to improve significantly compared to baseline (p < 0.05). Instrumental assessment revealed improvement in TEWL and erythema index, 49.7% and 17.4%, respectively. No adverse reaction was observed. 95% of patients were satisfied with the moisturizer and 90% perceived it to be better than the one in the market. There was a 55.07% reduction in the use of hydrocortisone 1% cream toward the end of the study (p < 0.05).

Conclusions

The results suggested that tocotrienol-rich moisturizer is safe and effective in the management of AD in young children.     

Case study: enhancing compliance in an adolescent with atopic dermatitis.

Compliance in the adolescent with atopic dermatitis can be a challenge to the dermatology nurse. Compliance can be enhanced through education and followup with the patient, his/her family, school, and other health care professionals.     

Frequency of contact allergy in children with atopic dermatitis: results of a prospective study of 137 cases

The aim of our study was the evaluation of contact sensitization in pediatric patients with atopic dermatitis (AD). It seems that the frequency of contact allergies in the course of AD, and also the frequency of contact allergies in children, is underestimated in general. Our study has been performed by investigating 137 children with AD. The childrens' history was taken according standardized consultation guidelines and followed by a physical examination. Patch testing was performed systematically, including the European standard series, together with tixocortol pivalate, budesonide and the applied emollient. If necessary, optional patch tests were performed according to the child's history. The results demonstrate contact sensitization in 43% of all children tested. The most frequent contact allergens are: metals (19.3%), fragrance (4.4%), balsam of Peru (2.6%), lanolin (4.4%), neomycin (2.6%) and emollients (2.6%). No contact sensitization to corticosteroids nor any induction of active sensitization were seen. Statistical analysis demonstrates that the risk of developing a contact allergy is significantly elevated in children after the age of 5 years. Female sex is a risk factor only for nickel. Age of onset of AD or its severity is not associated with the development of contact allergy. In conclusion, the results indicate the necessity of performing systematic patch testing in the investigation of allergies in children with AD. Preventive measures from an early age are suggested to avoid exposure to the most frequent contact allergens.     

Efficacy and tolerability of a Chinese herbal medicine concoction for treatment of atopic dermatitis: a randomized, double-blind, placebo-controlled study

BACKGROUND: There has been considerable interest in traditional Chinese herbal medicine (TCHM) as a treatment for atopic dermatitis (AD). A twice-daily concoction of an ancestral formula containing five herbs has been found to be beneficial in an open study. OBJECTIVES:To assess the efficacy and tolerability of the concoction in children with AD. METHODS: Following a 2-week run-in period, children with long-standing moderate-to-severe AD were randomized to receive a 12-week treatment with twice-daily dosing of three capsules of either TCHM or placebo. The SCORing of Atopic Dermatitis (SCORAD) score, Children's Dermatology Life Quality Index (CDLQI), allergic rhinitis score, and requirement for topical corticosteroid and oral antihistamine were assessed before and at weeks 4, 8, 12 and 16 after treatment. Adverse events, tolerability, haematological and biochemical parameters were monitored during the study. RESULTS: Eighty-five children with AD were recruited. Over 12 weeks, the mean SCORAD score fell from 58.3 to 49.7 in the TCHM group (n = 42; P = 0.003) and from 56.9 to 46.9 in the placebo group (n = 43; P = 0.001). However, there was no significant difference in the scores at the corresponding time points between the two groups. The CDLQI in TCHM-treated patients was significantly improved compared with patients receiving placebo at the end of the 3-month treatment and 4 weeks after stopping therapy (P = 0.008 and 0.059, respectively). The total amount of topical corticosteroid used was also significantly reduced by one-third in the TCHM group (P = 0.024). No serious adverse effects were observed between the groups. CONCLUSIONS: The TCHM concoction is efficacious in improving quality of life and reducing topical corticosteroid use in children with moderate-to-severe AD. The formulation was palatable and well tolerated.