Effects of a novel formulation of fluocinonide 0.1% cream on skin barrier function in atopic dermatitis.

OBJECTIVE: To determine the effect a novel formulation of fluocinonide cream on skin barrier function in subjects with atopic dermatitis. DESIGN: The authors performed an open-label, investigator-blinded, side-by-side, controlled trial examining skin barrier function before and after a two-week course of a class I, super-potent topical steroid. SETTING: Outpatient university-based dermatology clinic in Portland, OR. SUBJECTS: Twenty-five subjects aged 12 or older with a diagnosis of moderate, severe, or very severe AD were recruited for this study. INTERVENTION: Fluocinonide 0.1% cream, a novel formulation of a class I super-potent topical steroid was applied to all affected areas, except a control site, once daily for two weeks or until clear. The control target site was treated with the vehicle once daily. MAIN OUTCOME MEASURE(S): The study's primary outcome was change in skin barrier function as measured by basal transepidermal water loss (TEWL) in acute lesional skin from baseline as measured at two weeks. RESULTS: TEWL readings significantly decreased (reflecting improved barrier function) in both the active and control target sites. The active target site decreased 14.35+/-16 mg/cm2 per hour; 95 percent confidence interval, P<0.001. The control target site decreased 8.75+/-11.80 mg/cm2 per hour in 25 subjects; 95 percent confidence interval, P<0.001. Skin electrical capacitance also improved significantly, reflecting improved stratum corneum hydration with therapy. Pruritus, clinical severity, and quality of life scores all showed significant improvement by the end of the study. CONCLUSION: The authors have shown that short-term treatment with a novel formulation of 0.1% fluocinonide led to significantly improved barrier function as measured by basal TEWL in subjects with active moderate to severe AD. These data suggest short-term treatment with AD with a super-potent corticosteroid improves skin barrier function.

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.

Patients preferences for different corticosteroid vehicles are highly variable.

Introduction: Topical corticosteroids, available in an array of vehicles are used to control a variety of inflammatory skin diseases. Patients preferences for different vehicles may affect their willingness to use treatment. We assess corticosteroid vehicle preference and potential impact of topical characteristics on adherence and quality of life in patients with psoriasis.Methods: Subjects with psoriasis were recruited from Wake Forest University Dermatology Clinic. Subjects sampled desoximetasone 0.25% spray, betamethasone valerate 0.1% cream, triamcinolone acetonide 0.1% ointment, fluocinonide 0.05% gel, betamethasone valerate 0.1% lotion, clobetasol propionate 0.05% foam, and fluocinonide 0.05% solution in a predetermined randomized order. Subjects completed a Vehicle Preference Measure, Determinants of Adherence Measure, and a Determinants of Quality of Life Measure.Results: Patients preferences for the various products were highly variable. Regarding Determinants of Adherence, patients perception of absorption of the medication was ranked as 'quite important/extremely important' by 85% of total subjects. A majority of patients rated medication side effects as 'quite important/extremely important' when asked to consider topical characteristics effect on quality of life.Discussion: There was wide variation in patient preference for topical medication vehicles used for treating psoriasis. Several vehicle characteristics were considered important to adherence. Given the marked variation in vehicle preference, topical treatment should be individualized according to patients preferences.

Case report: Fluocinonide-induced perioral dermatitis in a patient with psoriasis.

Topical corticosteroids are the primary treatment for psoriasis. A patient with psoriasis being treated with topical fluocinonide for lesions on the extremities developed an erythematous facial eruption consistent with perioral dermatitis. When topical agents are applied, they often end up in unintended areas. The potential for drug-induced perioral dermatitis should be considered in psoriasis patients treated with potent topical corticosteroids.

Central serous retinopathy associated with topical oral corticosteroid use: a case report.

BACKGROUND: Oral topical corticosteroid gels are widely used in dental medicine. Case studies of central serous retinopathy have been reported following administration of corticosteroids, but none so far coinciding with the use of topical fluocinonide gel. This case report further contributes to the database of potential risks of corticosteroid use. CASE PRESENTATION: A 40-year-old South Asian woman presented with decreased vision, pigment epithelial detachments, and serous retinal detachments in both eyes 1 month after starting treatment with topical fluocinonide 0.05%, a topical oral corticosteroid gel. Her condition resolved 6 months after discontinuing the use of the steroid. CONCLUSIONS: To the best of our knowledge, this is the first case of idiopathic central serous retinopathy associated with the use of oral fluocinonide gel. Discontinuing the use of the steroid may result in resolution of the serous retinal detachment and improvement of visual symptoms. Patients and their doctors who prescribe this medication should be aware of this association.

In vivo determination of the skin atrophy potential of the super-high-potency topical corticosteroid fluocinonide 0.1% cream compared with clobetasol propionate 0.05% cream and foam, and a vehicle.

PURPOSE: Prolonged topical corticosteroid use is often associated with atrophic skin changes. This trial compared signs of skin atrophy related to 3 super-high-potency corticosteroids: fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, and 0.05% foam. PATIENTS AND METHODS: The test treatments were applied to the forearms 10 females twice daily for 21 days. Skin characteristics were assessed pretreatment and posttreatment for atrophic changes. Further punch biopsies obtained from 5 subjects were assessed histologically. RESULTS: Clobetasol foam produced mild changes in noninvasive tests, but stained skin biopsies revealed structural changes nearly comparable to clobetasol cream, which showed substantial atrophic changes. Fluocinonide cream was the least atrophogenic, producing no or only mild effects that were slightly greater than vehicle. CONCLUSIONS: Fluocinonide cream has a lower potential to produce atrophic changes of the skin than either clobetasol cream or clobetasol propionate foam.

A single-center, double-blind, randomized trial of the atrophogenic effects of fluocinonide cream 0.1% versus clobetasol propionate cream 0.05% in participants with corticosteroid-responsive dermatoses.

To compare the atrophogenic effects of fluocinonide cream 0.1% versus clobetasol propionate cream 0.05%, 20 participants with corticosteroid-responsive dermatoses were randomly assigned to receive fluocinonide cream 0.1% on one arm and clobetasol propionate cream 0.05% on the other arm. Study medications were applied to disease-free target areas on the inner arms twice daily for 2 weeks. The epidermal thickness of pretreatment and posttreatment punch biopsy specimens was measured. Skin examinations were performed evaluating clinical signs of atrophy. No significant reduction in epidermal thickness was observed in the fluocinonide-treated sites (mean, -0.0318 mm; standard deviation, 0.0239; P=.1991). A significant reduction in epidermal thickness was seen in the clobetasol-treated sites (mean, -0.1825 mm; standard deviation, 0.0239; P<.0001). This reduction was significantly greater than results from sites treated with fluocinonide cream 0.1% (difference, -0.1507; standard deviation, 0.0131; P<.0001). Although topical corticosteroids often are the first-line treatment for patients with various dermatoses, a side effect of continuous use is cutaneous atrophy. Our study demonstrated that clobetasol propionate cream 0.05% caused a significantly greater reduction in epidermal thickness compared with fluocinonide cream 0.1% when used twice daily for 2 weeks (P<.001). However, neither drug caused significant clinical signs of atrophy.

Transient band-like keratopathy after treatment for seborrheic dermatitis.

PURPOSE: To describe a case of transient band-like keratopathy after ocular exposure to fluocinonide cream and ketoconazole shampoo. DESIGN: Observational case report. RESULTS: A 40-year-old patient presented with acute pain, photophobia, lacrimation, and redness in 1 eye. The symptoms began while using fluocinonide cream and ketoconazole shampoo as treatment of seborrheic dermatitis of the scalp. Examination revealed white clumpy deposits in a horizontal band across the inferocentral corneal epithelium and conjunctival hyperemia. Corneal scrapings revealed no cells or organisms, and culture was negative. The lipophilic deposits dissolved during slide fixation and processing. With conservative treatment the deposits resolved in 3 days. CONCLUSION: We present a case of transient band-like corneal deposit, a novel complication of fluocinonide and ketoconazole exposure.

Steroid rosacea in children.

Steroid rosacea is a facial dermatitis clinically resembling acne rosacea. Fluorinated topical steroids have been implicated as the cause or precipitating factor in previous case reports mainly involving an adult population. Four cases of pediatric acne rosacea associated with the use of topical fluorinated glucocorticosteroids are described. The process worsened during the two weeks following steroid cessation. We recommend that fluorinated glucocorticosteroids should not be used on the face of infants and children.

Comparative efficacy of halcinonide and fluocinonide creams in psoriasis and eszematous dermatoses.

The clinical efficacy of halcinonide and fluocinonide creams was compared in the treatment of 392 patients with corticosteroid-responsive dermatoses, including psoriasis, and various eczematous dermatoses such as atopic dermatitis, eczematous dermatitis, and neurodermatitis. The severity of the condition treated was moderate or severe in most of the patients. Usually, the creams were applied three times daily for two to three weeks. In psoriasis, halcinonide was superior to fluocinonide (P less than 0.05). There was no significant difference between halcinonide and fluocinonide in the treatment of the eczematous dermatoses. Both creams were well tolerated, each being associated with local side effects (such as burning sensation, dryness, erythema, and pruritus) in 4.9 per cent of patients.

A controlled clinical trial of a new formulation of betamethasone dipropionate cream in once-daily treatment of psoriasis.

In a multicenter, evaluator-blind, parallel group study of 244 patients with moderate to severe psoriasis, a once-daily application of a new formulation of beta-methasone dipropionate 0.05% cream, augmented formulation (AF), and a twice-daily application of fluocinonide 0.05% cream were compared, with respect to safety and efficacy. Results significantly favored betamethasone dipropionate AF over fluocinonide, as indicated by improvements in signs of erythema, induration, and scaling, as well as the physicians' and patients' global evaluations of response after 14 days of treatment. As a result of adverse experiences, treatment had to be discontinued in three patients on fluocinonide. No patient on betamethasone dipropionate AF had to discontinue treatment.

Multicenter study comparing 0.05% gel formulations of desoximetasone and fluocinonide in patients with scalp psoriasis.

A double-blind, multicenter study was conducted to evaluate and compare the safety and efficacy of desoximetasone gel 0.05% and fluocinonide gel 0.05% in patients with scalp psoriasis. One hundred twenty-five patients were enrolled in this randomized, parallel-group trial. Responses based on clinical assessment in 123 patients showed that the desoximetasone gel formulation is a safe and effective treatment for psoriasis of the scalp. Although efficacy appears equivalent to that of fluocinonide gel 0.05% in treating psoriasis of the scalp, desoximetasone appears to be slightly better tolerated and better accepted cosmetically.

Risks of unoccluded topical steroids in clinical trials.

Data were reviewed on the beneficial responses and adverse reactions among 2,849 patients in 14 paired-comparison studies with eight unoccluded topical corticosteroids in six steroid-responsive dermatoses. Adverse reactions were found to be mild, transient, and, for the most part, rare. Of 5,698 treatment exposures, 249 (4.39%) adverse reactions were reported, including irritation (1.3%), itching (0.95%), burning (0.81%), dryness (0.46%), scaling (0.30%), and vesicle formation (0.16%). Other reactions occurred in less than one in 1,000 treatment exposures. No severe reactions were observed. Five subjects (0.17%) terminated treatment early because of adverse reactions. The incidence of adverse reactions to vehicle alone was 6.7%. The benefit-risk ratio for mild reactions was 17:1. Therefore, long lists of adverse reactions are inappropriate in written consent forms for prospective volunteers for clinical trials. Al alternative warning statement is proposed.

Corticosteroid-induced cutaneous atrophy and telangiectasia. Experimental production associated with weight loss in rats.

A bioassay for the evaluation of certain adverse effects of various corticosteroids was performed. Twenty-eight daily topical applications of corticosteroids to young rats produced reduction in body-weight gain, atrophy of the skin as determined by double skin-fold thickness micrometer measurement, and mild to severe telangiectasia. This animal model demonstrates corticosteroid-induced skin atrophy and telangiectasia and the correlation of the degree of atrophy and telangiectasia to body-weight change. Nine corticosteroids were evaluated by this method and are listed in terms of increasing severity of side-effects as follows: 1.0% hydrocortisone cream, 0.1% betamethasone valerate cream, 0.025% betamethasone benzoate cream, 0.05% flurandrenolide cream, 0.05% fluocinonide cream, 0.1% dexamethasone cream, and 0.03% flumethasone pivalate cream. Triamcinolone acetonide cream, 0.5%, and 0.2% fluocinolone acetonide cream resulted in death of the animals prior to completion of 28 days of topical application.

Clinical comparison of desonide cream with fluocinonide cream in steroid-responsive dermatologic disorders.

Desonide, a nonfluorinated topical corticosteriod, was compared with fluocinonide, a potent fluorinated steroid, in identical concentrations, in the treatment of various steroid-responsive dermatologic disorders. In treatment comparisons, the group treated with desonide showed significantly (p less than 0.05) better erythema and scaling scores after the first week than did those in the fluocinonide group, but the two week scores were not significantly different. Although 5 percent of patients treated with fluocinonide had adverse reactions, no such reactions were observed in the desonide-treated group.

Oral lichen planus: patient profile, disease progression and treatment responses.

BACKGROUND: Oral lichen planus, or OLP, is a common mucocutaneous immunological disease. The objective of this study was to describe the patient profile, disease progression and treatment responses. METHODS: The authors conducted a retrospective, descriptive study using information from patient records at a tertiary referral center. The study included 229 patients with OLP who were seen in the oral medicine clinic at the University of California, San Francisco, between September 1996 and August 2000, for the first time or for a follow-up visit. Signs and symptoms at various clinic visits were quantified. Responses to treatment and disease progression were determined by comparing scores with baseline scores. RESULTS: The mean age at onset of the disease was 55 years, and 154 (67 percent) of the patients were female. Symptoms generally correlated directly with the severity of OLP forms, which ranged from reticular to erosive. Corticosteroids were effective in reducing symptoms, healing ulcers and reducing erythema. At last follow-up, 65 percent of the patients had the same type of OLP seen initially or the disease had progressed to a more severe type, while 35 percent of patients had less-severe forms than that seen at the initial visit. Four patients (1.7 percent) developed oral squamous-cell carcinoma during the follow-up period. CONCLUSIONS: OLP is a chronic disease with no known cure. Symptoms can improve with corticosteroids; however, the lack of long-term (that is, lifetime) treatment compliance and the adverse side effects of the drugs limit optimal results. CLINICAL IMPLICATIONS: Patients with OLP should be treated if symptoms are significant. Follow-up--including supervision of medication use and monitoring of side effects, as well as periodic examinations for possible malignant transformation--is necessary.

What's your assessment? Psoriasis with steroid atrophy.

The "What's Your Assessment?" series includes a short case presentation and differential diagnosis. It is followed by a discussion of the disease or condition and the rationale used in each step of the assessment.

[The topical treatment of atrophic-erosive oral lichen planus with fluocinonide in a bioadhesive gel, chlorhexidine and miconazole gel. A totally open trial]. / Il trattamento topico del lichen planus orale atrofico-erosivo con fluocinonide in gel bioadesivo, clorexidina e miconazolo gel. Un trial tutto aperto.

To evaluate the efficacy and long-term course of topical steroids treatment in oral lichen planus (OLP), an open trial has been carried out in 30 patients with atrophic-erosive or symptomatic varieties of OLP confirmed histologically with relative contraindications for systemic steroid treatment (namely, liver disease, peptic ulcer, diabetes, blood hypertension or osteoporosis). The treatment was the following: Fluocinonide (Topsyn) 0.025% in 4% idrossiethylcellulose gel applied 3 times/daily for two months, 2 times/daily for the next 2 months and 1 times/daily for other 2 months. Moreover, chlorhexidine (Plakout) 0.12%, 3 mouthwashes/daily and miconazole gel (Micotef) applied 1 times/daily were used for the entire period of the steroid therapy as antimycotics. The clinical evaluation of signs and symptoms was assessed on a scale of 0 to 5 and of 0 to 3, respectively. Twenty patients concluded the entire therapeutical scheme, whereas 5 (17%) interrupted the treatment for the appearance of side-effects (namely, gastroesophageal disturbances, mucosal bleeding and pruritus), 1 interrupted voluntarily the treatment and 4 cases did not present at the controls. No cases of oral candidiasis were seen. Eighteen patients (90%) had improvements of oral lesions with significant statically reductions in the scores of signs (p < 0.002) and of symptoms (p < 0.02) (Wilcoxon test). We emphasize also that in 61% of the responders the oral conditions were stable after 6 months of follow-up. In conclusion our results suggest the following: a) fluocinonide is an effective and safe drug for the treatment of OLP, especially in addition with chlorehixidine and miconazole; b) the stability of our results demonstrates that probably an adequate steroid therapeutical scheme is more useful than continuous steroid administration in the treatment of OLP.