Topical Corticosteroid Usage Research Articles

Effect of Corticosteroid Phobia on Treatment Adherence and Outcome in Women With Lichen Sclerosus: A Prospective Study.

The phenomenon of topical corticosteroid (TC) phobia (TCP) poses a challenge to the adherence of patients requiring prolonged treatments, particularly those with conditions like atopic dermatitis. Nonadherence to treatment significantly contributes to the inadequate control of diseases. This study aimed to evaluate TCP among women suffering from vulvar lichen sclerosus (VLS) and its potential impact on treatment adherence and therapeutic outcomes. This observational, prospective study involved adult patients who received their first histological diagnosis of VLS and underwent a 12-week corticosteroid treatment regimen at our Vulva Unit between June 2022 and September 2023. All participants completed the validated TOPICOP questionnaire, which assesses concerns, worries, and beliefs regarding TC usage. Baseline and 12-week control visit assessments were conducted to evaluate subjective and objective parameters of VLS. Patient adherence to treatment was monitored through diary entries. Among the 50 patients included (with a mean age of 64.9 ± 13.5 years), more than half (58%) had prior experience with TC treatments and 10.3% had used corticosteroids for vulvar symptoms without a precise diagnosis. The median global TOPICOP score was 19.4% (interquartile range = 5.6-36.1), with a corresponding median value of 7.0 (interquartile range = 2.0-13.0). A total of 41 patients (82.2%) adhered to the study treatment, which proved highly effective in alleviating symptoms and improving signs of VLS. Multivariate analysis revealed that neither treatment adherence nor effectiveness were significantly associated with the level of TCP. Among our VLS patients, TCP was relatively low and did not negatively impact treatment adherence to corticosteroids. Moreover, TCP did not influence the effectiveness of TC therapy, as it did not affect adherence.

Topical Prescription Management.

With recent advances in topical therapies for atopic dermatitis (AD), steroid-sparing options like calcineurin inhibitors, Janus kinase (JAK) inhibitors, and phosphodiesterase-4 (PDE-4) inhibitors are becoming mainstays in therapy, underscoring the importance of careful selection and usage of topical corticosteroids (TCSs) to minimize side effects. Alongside the necessity of emollient use, these steroid-sparing alternatives offer rapid itch relief and efficacy in improving disease severity. While TCSs still hold a prominent role in AD management, promising novel topical treatments like tapinarof and live biotherapeutics to modulate the skin microbiome are also discussed. Overall, the recent addition of novel topical therapies offers diverse options for AD management and underscores the importance of topical treatments in the management of AD.

CLINICO-EPIDEMIOLOGICAL STUDY OF TOPICAL STEROID DAMAGED FACE IN A TERTIARY CARE HOSPITAL

Objectives- The aim of the study was to determine the clinical features, extent, and dermographics of topical corticosteroid usage on the face in patients who were seen in the dermatology outpatient department. Materials and Methods: Between August 2022 and August 2023, a questionnaire-based analysis of patients attending the dermatology outpatient department of a tertiary care hospital was conducted. The study was comprised of 200 subjects who applied topical steroid on their face for more than 6 weeks and they were enquired regarding their history. Clinical assessment, and lesion photography was also done. Results: 200 patients with topical steroid damaged face were examined in the study. The most prevalent age range for topical steroid use was between 18 and 30 years which comprised 42% of total patients in the study. Out of 200 patients 149 were women [74.5%]. The average time between commencing the topical steroid regimen and the appearance of symptoms was six months. 74 [39.5%] used topical steroids to treat dermatophyte infections and the remaining subjects used them for miscellaneous reasons. In this study population, cream-based betamethasone valerate was the most frequently misused steroid. The most frequent adverse effect was hyperpigmentation (27%) followed by acneiform eruptions (25%) facial erythema (18%), hypertrichosis (12%), perioral dermatitis (4%) and skin atrophy (5%), hypopigmentation(9%). Conclusion: Topical steroid damaged face is a dermatological concern. The public must be made aware of the possible danger of topical steroid abuse to stop its indiscriminate use.

An Analysis of Literature on Topical Steroid Withdrawal in Dermatology

Topical steroids have been used to treat a variety of dermatological conditions and are one of the most commonly prescribed drugs in dermatology. These are Food and Drug Administration (FDA)-approved medications for treating diseases such as eczema, vitiligo, atopic dermatitis, discoid lupus erythematosus, and more. The mechanism of action of topical corticosteroids consists of anti-inflammatory, anti-mitotic, and immunosuppressive effects. Patients on topical corticosteroid treatments must be monitored carefully as there is a potential for adverse effects, especially in treatments lasting longer than several weeks. While when properly prescribed and monitored topical corticosteroid usage is considered safe, there have been growing concerns surrounding topical corticosteroid abuse, phobia, and withdrawal. Current research has focused on new therapeutic strategies and management protocols to improve long-term patient outcomes and mitigate the adverse effects of these drugs. In this narrative review, we describe the recent findings of clinical manifestations, patient perspectives in the literature, current knowledge, and misinformation and abuse pertaining to topical steroids.

A Prospective Prescription Audit of Topical Corticosteroid usage at Skin OPD in a Tertiary Care Centre

Introduction: Topical corticosteroids are used for various conditions in dermatology like vitiligo, eczema and psoriasis. They should be used rationally to minimize the side effects. The present study is done to document and improve the pattern of prescribing topical steroids among patients attending Skin OPD at tertiary care centre. Material & Methods: The study was a prospective audit of 100 prescriptions issued to the patients in skin OPD. The data was collected for age and sex of patients, dermatosis for which it is prescribed, number and molecule of drugs, with its dose, site, duration, strength, quantity and frequency of administration. Descriptive statistics was used for analysis. Results: Present study is an audit of 100 prescriptions. Sixty two patients were males and 49% were in 13-40 years of age group. Most common skin condition for which topical steroid prescribed was eczema in 34%. Average 3-6 drugs were prescribed in majority (82%) of prescriptions. The potent corticosteroids was the most frequently prescribed group in 46% prescriptions and most common molecule prescribed was betamethasone valerate in 27%. In 73% prescriptions twice daily application was advised. Maximum 50% prescriptions of TCS were for 7-15 days and site of application was mentioned in 70%. Generic and brand names were mentioned in all prescriptions with quantity of drug. Fingertip unit application was mentioned in 3% of prescriptions. Conclusion: The most common indication for prescribing topical steroids was eczema and the most common molecule prescribed was betamethasone valerate. Generic and brand names for drugs were used in all prescription, but advice about Finger tip method application was not a routine practice.

Topical cannabidiol (CBD) in skin pathology - A comprehensive review and prospects for new therapeutic opportunities.

Humans have utilised cannabis products in various forms throughout the recorded history. To date, more than 500 biologically active components have been identified in the plants of the Cannabis genus, amongst which more than 100 were classified as phytocannabinoids (exocannabinoids). The plant genus Cannabis is a member of the plant family Cannabaceae, and there are three primary cannabis species which vary in their biochemical constituents: Cannabis sativa, Cannabis indica and Cannabis ruderalis. There has been a growing level of interest in research on the topical usage of a cannabis-based extract as a safer and more effective alternative to the usage of topical corticosteroids in treating some dermatoses. Together with the discovery of the cannabinoid receptors on the skin, it has been further illustrated that topical cannabis has anti-inflammatory, anti-itching, analgesics, wound healing and anti-proliferative effects on the skin.

Frequent Versus Infrequent Bathing in Pediatric Atopic Dermatitis: A Randomized Clinical Trial

Studies evaluating bathing frequency in pediatric atopic dermatitis (AD) are limited. Parents of children with AD often receive conflicting information, leading to frustration and confusion. To evaluate efficacy of twice-daily soaking baths, followed by immediate application of an occlusive moisturizer (ie, soak-and-seal [SS]), versus twice-weekly SS baths, in the acute management of pediatric AD. We conducted a randomized, single-blind, crossover-controlled trial comparing frequent versus infrequent SS baths, in children 6 months to 11 years of age with moderate-to-severe AD. Children were randomized 1:1 into 2 groups: group 1 underwent twice-weekly SS baths, for 10 minutes or less, over 2 weeks ("dry method" [DM]) followed by twice-daily SS baths, for 15 to 20 minutes, over 2 weeks ("wet method" [WM]). Group 2 did the inverse. Patients received the same moisturizer, cleanser, and low-potency topical corticosteroid (TCS). Primary outcome was AD severity evaluated using the SCORing Atopic Dermatitis (SCORAD) index. Caregiver assessment of AD severity (Atopic Dermatitis Quickscore [ADQ]), quality of life, Staphylococcal aureus colonization, skin hydration, moisturizer, and TCS usage were assessed. Of the 63 children screened, 42 fulfilled inclusion criteria and were randomized. Forty (95%) completed the study. WM decreased SCORAD by 21.2 compared with DM (95% confidence interval [CI], 14.9-27.6; P < .0001). Secondary analysis showed a greater than 30% SCORAD improvement for WM versus DM (McNemar's χ2= 8.83, df= 1, P= .0030). SCORAD correlated with ADQ (r= 0.66), and ADQ also showed significant improvement with WM decreasing ADQ by 5.8 (95% CI, 1.8-9.7). No other secondary endpoints showed significance. As an acute treatment intervention, WM is superior to DM at improving disease severity in moderate-to-severe pediatric AD.

Medication use in patients with chronic rhinosinusitis in Germany - a large retrospective patient-based study.

The aim of the present study was to provide an insight into medical treatment practices among patients with chronic rhinosinusitis (CRS) in Germany. An investigation of ICD codes and ATC classes of CRS patients in general and otolaryngology offices in Germany should reveal the prevalent treatment behaviors of German physicians. The present study used data from the Disease Analyzer database (IQVIA). The study sample included patients from 940 general (GP) and 106 otolaryngology (ENT) practices who were coded as having chronic sinusitis (ICD-10: J32) or nasal polyps (ICD-10: J33) in 2015 (index date). The primary outcome measures were the number of patients with these diagnoses per practice as well as the proportion of patients with prescriptions for topical corticosteroids, systemic corticosteroids, antibiotics, antihistamines, and local decongestants within 365 days after the first diagnosis. This retrospective study included 26,768 patients with coding for chronic sinusitis (ICD-10: J32) and 516 patients for nasal polyps (ICD-10: J33) in 940 GP practices and 19,826 patients with coding for chronic sinusitis (ICD-10: J32) and 1,773 patients for nasal polyps (ICD-10: J33) in 106 ENT practices. In patients coded as having chronic sinusitis (ICD-10: J32), topical corticosteroids were prescribed at a low rate (GP: 12.3%, ENT: 34.3%). In patients coded as having nasal polyps (ICD-10: J33), topical corticosteroid usage was higher in GP practices (27.3%) and in ENT practices (71.2%). Topical corticosteroid usage in CRS patients in GP practices in Germany is as low as in other Western countries. Increased usage of topical corticosteroids in CRS patients with polyposis should be encouraged in GP and ENT practices.

Topical steroid abuse on face: a prospective study from a tertiary care centre of north India

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Topical corticosteroids (TCS) are widely misused on face which is associated with significant adverse effects and poor awareness of these effects. The aim of this study was to assess the frequency of misuse of topical corticosteroids, the causes behind it and the most common adverse events resulting from it and to make aware the people about it&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This study was conducted at Dermatology Department of Govt. Medical College, Kota during period of one year from July 2015 to June 2016. A total of 670 patients using topical steroids over face were enrolled in the study. Details about the usage of topical corticosteroids and their side effects were recorded.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; Majority of the patients were females (72.68%). The most common reason for misuse was melasma (57. 91%) followed by use as a fairness cream (22.38%). Most of the patient used topical steroid cream for duration of 3-6 months (33.13%). Most common age group was 21-30 years (48.20%). Acne form eruption (38.05%) and rebound erythema (28.20%) were the most common adverse effects noted. Patients were ignorant of the ingredients and their side effects.&lt;/p&gt;&lt;p class="Default"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Steroids have been misused by patients on their own or by pharmacist and non-dermatologist physicians for various reasons. Topical steroid should not be used on the face unless it is under strict dermatological supervision. &lt;/p&gt;

Association of Moisturization and Topical Corticosteroid Usage During and After Whole-Breast Radiation Therapy: A Post Hoc Analysis of a Randomized Controlled Trial

Association of Moisturization and Topical Corticosteroid Usage During and After Whole-Breast Radiation Therapy: A Post Hoc Analysis of a Randomized Controlled Trial

Topical corticosteroid abuse on the face: a prospective, study on outpatients of dermatology

Introduction: Topical corticosteroids (TCS) are widely misused. Uncontrolled use of steroids can cause undesirable adverse effects especially on face. Aim: The aim of this study was to assess the skin manifestations of TCS misuse over the face in the patients attending dermatology outpatient and to analyze various factors contributing to such misuse. Methods and Methods: A total of 200 patients with facial dermatoses using topical steroids over face for minimum period of 1 month, reported between June 2010 and May 2011 were enrolled in the study. Details about the usage of topical corticosteroids and their side effects were recorded. The patients were educated about the misuse. Results: Majority of the patients were females (71%). The most common reason for misuse was acne (61%) followed by use as a fairness cream (23%). The average duration of usage was 6 months to 1 year, longest being 8 years. The drug most commonly misused was Betamethaone Valerate (71%). The commonest side effect noted was acne form eruptions (52%) followed by steroid dependent face (SDF) (36%). There were no cases of allergic contact dermatitis or perioral dermatitis. The exacerbation of the lesions on stoppage of steroid cream (90%) fairness effect (10%) were the reasons for continued use. (100%) were unaware of side effects of topical steroids. Conclusions: Steroids have been misused by patients on their own or by doctors for various reasons. Hence the awareness about their correct usage is essential.

Topical Corticosteroid Usage in Dermatology OPD in a Medical Teaching Hospital

Topical corticosteroids constitute the most commonly prescribed drugs in the treatment of dermatological conditions. Self medication and erratic use of these agents by patients can increase the risk of developing local and systemic side effects. To find out the trend and outcome of topical corticosteroid usage in a Tertiary Care Hospital a retrospective analysis of the prescriptions in the Department of Dermatology was done for a period of six months. Data on age, sex, diagnosis, steroids and their combinations used, delivery vehicle, potency, frequency of application, duration of treatment and adverse effects were recorded on a pre-designed proforma and analyzed. Mid potency topical steroids were commonly used followed by high, low and very high potency preparations. Age range varied from 5-65 years. Mid and high potency steroids were used in combination with antimicrobials and salicylic acid. Cream based preparations were commonly used and duration of treatment was appropriate and rational. Adverse effects were seen only in four cases and no irrational prescriptions were noted.

Paradoxical use of oral and topical steroids in steroid-phobic patients resorting to traditional Chinese medicines

Childhood-onset eczema is a common condition associated with pruritus, sleep disturbance and disrupted quality of life. The mainstay of treatment is usage of emollients and topical corticosteroid (CS). Nevertheless, many steroid-phobic parents are very skeptical about western medicine that may contain CS. Furthermore, complementary and alternative medicine (CAM) is popular among Chinese patients in Asia and many citizens idolize CAM and believe that traditional Chinese medicine and herbs are without any side effects. Pressed by public's quest for efficacious and safe treatment, and lucrative profits, CAM practitioners may take the risks of prescribing steroids and "western medicine" in the name of traditional Chinese herbal medicine. We report a series of illustrative cases of uninformed systemic and topical corticosteroid usage for eczema by steroid-phobic parents to alert the public of this risk. The drugs were detected by high-performance liquid chromatography with diode-array detection, liquid chromatography-tandem mass spectrometry, gas chromatography mass spectrometry, or liquid chromatography ion trap time-of-flight mass spectrometry. Five cases of uninformed corticosteroid usage for moderate-to-severe eczema by steroid-phobic parents were reported. The physician caring for children with skin disease should also be aware that even steroid-phobic parents might indeed be using potent CS without awareness. The patient usually suffers chronic relapsing eczema of moderate-to-severe degree. The steroid-phobic parent is usually non-compliant in following advice on usage of emollient, topical CS, and avoidance of triggers in accordance with western doctors. The CAM practitioner, when confronted by an anxious steroidophobic parent who demands efficacious topical and/or systemic treatment, may knowingly or unknowingly be forced into prescribing potent albeit illegal products containing corticosteroids in the name of traditional Chinese herbal medicine.

Clinical Efficacy of Blue Light Full Body Irradiation as Treatment Option for Severe Atopic Dermatitis

BackgroundTherapy of atopic dermatitis (AD) relies on immunosuppression and/or UV irradiation. Here, we assessed clinical efficacy and histopathological alterations induced by blue light-treatment of AD within an observational, non-interventional study.Methodology/Principal Findings36 patients with severe, chronic AD resisting long term disease control with local corticosteroids were included. Treatment consisted of one cycle of 5 consecutive blue light-irradiations (28.9 J/cm2). Patients were instructed to ask for treatment upon disease exacerbation despite interval therapy with topical corticosteroids. The majority of patients noted first improvements after 2–3 cycles. The EASI score was improved by 41% and 54% after 3 and 6 months, respectively (p≤0.005, and p≤0.002). Significant improvement of pruritus, sleep and life quality was noted especially after 6 months. Also, frequency and intensity of disease exacerbations and the usage of topical corticosteroids was reduced. Finally, immunohistochemistry of skin biopsies obtained at baseline and after 5 and 15 days revealed that, unlike UV light, blue light-treatment did not induce Langerhans cell or T cell depletion from skin.Conclusions/SignificanceBlue light-irradiation may represent a suitable treatment option for AD providing long term control of disease. Future studies with larger patient cohorts within a randomized, placebo-controlled clinical trial are required to confirm this observation.

Prospective self-controlled trial of the efficacy and tolerability of a herbal syrup for young children with eczema

Objectives: Traditional Chinese medicine (TCM) is popular as an alternative medicine in children with atopic dermatitis (AD). A concoction of five herbs in a capsular preparation has been confirmed to be efficacious in improving the quality of life and sparing topical corticosteroid usage. We evaluated the clinical efficacy and tolerability of the same concoction in syrup form. Methods: This was a prospective self-controlled trial set in the pediatric dermatology clinic of a teaching hospital. Children aged 4–7 years with moderate-to-severe AD received 20 ml of TCM syrup daily. Clinical parameters and laboratory markers were measured before and at 2 weeks, 7 weeks and 12 weeks of treatment, and at 4 weeks after completion. Disease severity was evaluated by the SCORing Atopic Dermatitis (SCORAD) index and quality of life by the Children's Dermatology Life Quality Index (CDLQI). Blood was obtained for a complete blood count, total IgE, eosinophil count, and biochemical studies prior to and after 3 months of TCM usage. Results: Twenty-two patients participated in the study. There were significant improvements in the objective SCORAD, pruritus and CDLQI scores 4 weeks after study completion. There was no change in sleep score or amount of topical steroid consumption. No biochemical evidence of any adverse drug reaction was observed during the study period. The TCM syrup was generally palatable and well tolerated by the children. Adverse effects were generally mild but two patients with rash withdrew during the study. Conclusion: The palatability means that further evaluations and dosage studies of the concoction will be possible in young children.

What’s new in atopic eczema? An analysis of systematic reviews published in 2008 and 2009

This review summarizes clinically important findings from nine systematic reviews of the causes, treatment and prevention of atopic eczema (AE) published between August 2008 and August 2009. Two systematic reviews concluded that there is a strong and consistent association between filaggrin (FLG) mutations and development of eczema. The associations between FLG mutations and atopic sensitization, rhinitis and asthma are weaker than between FLG mutations and eczema, especially if those who also have eczema are excluded. The relationship between transforming growth factor levels in breast milk and eczema development is still unclear. A further systematic review found no strong evidence of a protective effect of exclusive breastfeeding for at least 3 months against eczema, even in those with a positive family history of atopy. Based on a systematic review and meta-analysis of six randomized controlled trials, supplementation with omega-3 and omega-6 oils is unlikely to play an important role in the primary prevention of eczema or allergic diseases in general. There is little evidence to support dietary restrictions of certain foods in unselected children with AE. There is also little evidence to suggest a clinically useful benefit from using probiotics in patients with established eczema. A systematic review of topical pimecrolimus and tacrolimus added little additional information to previous reviews, and did not provide any new data on long-term safety. Both of these drugs work in AE, and may reduce flares and usage of topical corticosteroids; however, there is still uncertainty about how they compare with topical corticosteroids.

The value of pimecrolimus in improving quality of life of children with severe eczema—an open non-randomised study

AbstractBackground: Atopic eczema is a common skin condition. It has the potential to severely impair quality of life in affected children. Pimecrolimus is currently registered for mild-moderate eczema but in clinical practice children with more severe disease are often treated with this therapy in an attempt to find a safe addition to long-term topical corticosteroid usage. The aim of this study was to test the value of pimecrolimus in improving quality of life in children with severe atopic eczema.Methods: This a single site, phase 4, non-randomised, open label trial of pimecrolimus use in children aged 4 months to 12 years living with moderate to very severe atopic eczema. The study was conducted at Steve Biko Academic Hospital. Patients with unsatisfactorily controlled disease despite conventional topical therapy, adequate use of emollients, allergen avoidance and non-pharmacological skin hygiene were enrolled. A Parent Index Quality of Life Questionnaire was completed by parents before and three mont...

Three Times Weekly Tacrolimus Ointment Reduces Relapse in Stabilized Atopic Dermatitis: A New Paradigm for Use

Long-term, safe and effective therapeutic options for managing the chronic relapsing nature of atopic dermatitis are essential for improving patient quality of life. To minimize the risks of continued topical corticosteroid usage and potentially reduce the incidence of flares, we tested the efficacy and safety of a rotational paradigm of initial brief application of topical corticosteroid followed by long-term intermittent application of non-steroidal tacrolimus ointment to previously inflamed sites of dermatitis. In this 2-phase study, patients who were 2 to 15 years of age and had moderate to severe atopic dermatitis were randomly assigned to 4 days of twice-daily double-blind therapy with either alclometasone ointment 0.05% or tacrolimus ointment 0.03% (Phase I acute), followed by up to 16 weeks of twice-daily open-label tacrolimus ointment 0.03% (Phase I short-term). Patients whose disease stabilized underwent new randomization to double-blind tacrolimus ointment 0.03% or vehicle applied once daily, 3 times per week to clinically normal-appearing skin for up to 40 weeks (Phase II). Corticosteroid use was prohibited. Of 206 randomly assigned patients, 152 completed Phase I; 105 of 152 were randomly assigned into Phase II (68 tacrolimus ointment and 37 vehicle). There were no differences in adverse events between alclometasone and tacrolimus (Phase I) or between tacrolimus and vehicle (Phase II). In the acute period, alclometasone-treated patients showed greater improvement in atopic dermatitis signs and symptoms; thereafter, when all patients applied tacrolimus ointment (short-term), there were no differences. In Phase II, tacrolimus-treated patients had significantly more disease-free days compared with vehicle, significantly longer time to first relapse, and significantly fewer disease relapse days. For patients with stabilized moderate to severe atopic dermatitis, long-term intermittent application of tacrolimus ointment to normal-appearing but previously affected skin was significantly more effective than vehicle at maintaining disease stabilization, with a safety profile similar to vehicle.

Tacrolimus ointment in the treatment of occupationally induced chronic hand dermatitis

Occupational hand dermatitis (OHD) is a common and often chronic condition. Usage of topical corticosteroids is limited in long-term therapy because of potential side-effects. New treatment options are highly appreciated. To study efficacy and safety of tacrolimus in patients suffering from OHD. In a prospective, open, multicentre study, 29 patients with OHD of predominantly mild-to-moderate severity were treated with tacrolimus ointment (Protopic 0.1%) during a 4-week active treatment period with twice daily application followed by a 2-month optional treatment period. Efficacy was evaluated by the use of a standardized hand eczema score and by clinical severity rating, conducted on all study visits (screening, baseline and weeks 2, 4, 6, and 12). Adverse events were recorded for safety evaluation. The hand eczema score declined significantly after 2 weeks of treatment compared with baseline and further declined until the end of the study. Finally, 12 (44%) patients were clear of hand eczema. Worsening of the dermatitis occurred in 2 patients (7%). Clinical grading indicated improvement too. Overall tolerability was good. Topical tacrolimus might be an efficacious treatment option for chronic OHD. Blinded and randomized controlled studies are necessary to confirm the results of this pilot study.

A double‐blind, placebo‐controlled trial of montelukast in adult atopic eczema

Montelukast is an antagonist of cys-leukotriene receptors used mainly in the treatment of asthma- and seasonal-allergic rhinitis. Initial reports concerning the use of montelukast in atopic dermatitis (AD) have been encouraging, although not consistent. We have undertaken a randomized, double-blind, parallel-group, placebo-controlled trial to investigate further the efficacy of montelukast in the treatment of atopic eczema. Following a screening visit, subjects received placebo treatment for 2 weeks in a single-blind phase, followed after visit 2 by an 8-week, double-blind period of treatment with montelukast 10 mg daily or placebo. Subjects were patients aged 16-60 years under our care for treatment of AD of moderate severity, defined by a six-area, six-sign atopic dermatitis (SASSAD) score in the range 12-50. Response to treatment was assessed by investigators and by subjects using a seven-point scale, with response defined as marked improvement or better. In addition, the SASSAD score was used to monitor the severity of clinical signs. The proportion of skin involved was estimated and visual analogue scales were used to record the severity of pruritus and sleep disturbance. Topical corticosteroid usage was recorded using a five-point scale. Adverse events were recorded. Sixty subjects were recruited and 54 completed the study. The treatment groups were well matched for disease severity at baseline (SASSAD scores were 25 and 29 in the montelukast and placebo groups, respectively). There were no significant differences between the treatment groups in any of the parameters used to assess treatment response. The improvement in mean SASSAD score from baseline (visit 2) to the end of treatment was marginally superior in the placebo group, 1.41 points on montelukast vs. 1.76 on placebo, a difference of 0.35 (95% confidence interval -6.1 to 6.8). Adverse events were generally of a mild nature except for a brief septicaemic illness in one subject receiving montelukast. The data do not support previous reports of efficacy of montelukast in treatment of AD.