A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne.

BACKGROUND: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. OBJECTIVE: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. METHODS: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. RESULTS: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. CONCLUSION: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne.

Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin.

BACKGROUND: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. OBJECTIVE: The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). METHODS: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. RESULTS: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. CONCLUSION: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

Treatment of severe atopic dermatitis by topical immune modulation using dinitrochlorobenzene.

We present the results of a small uncontrolled pilot trial which suggest that contact sensitization to dinitrochlorobenzene and repeated weekly applications significantly improve the clinical status of severe atopic dermatitis in adults. Although no changes were noted in circulating levels of either lymphocyte subset populations or the serum cytokines assayed in this trial, our observations may be due to topical immune modulation by dinitrochlorobenzene. Larger controlled studies of dinitrochlorobenzene treatment in atopic dermatitis are warranted.

Seizures.

Seizures are one of the most common neurologic emergencies. This article reviews the emergency evaluation and treatment of seizures, including status epilepticus. Pseudoseizures related to drugs, alcohol, and pregnancy are also discussed.

Knowledge of New English vocabulary in amnesia: an examination of premorbidly acquired semantic memory.

To assess if amnesics have intact remote memory for general semantic information, we examined memory for vocabulary words with known dates of entry into the language between 1955 and 1989. Amnesics of mixed etiology with acute onset performed normally on both a recall and a recognition task. Korsakoff patients, in contrast, were impaired on both tasks and demonstrated a gradient such that their knowledge of words acquired during more recent time periods was worse than that of words acquired during more remote time periods. The improvement in performance associated with recognition testing was larger for Korsakoff patients than for control subjects and correlated significantly with a composite measure of frontal dysfunction. These findings suggest a deficit in the controlled search and retrieval of semantic information in Korsakoff patients. The implications of the differential performance of Korsakoff and mixed etiology amnesics for explanations of temporally graded retrograde amnesia are discussed.

Cetirizine and astemizole therapy for chronic idiopathic urticaria: a double-blind, placebo-controlled, comparative trial.

BACKGROUND: Cetirizine and astemizole have been shown to be safe and effective in the treatment of patients with chronic idiopathic urticaria. Cetirizine brings about clinical benefit more rapidly. OBJECTIVE: The purpose of this study was to compare the efficacy of single daily doses of cetirizine and astemizole in relieving the symptoms of chronic idiopathic urticaria, with particular emphasis on the commencement of action. METHODS: Patients with chronic idiopathic urticaria were randomly assigned to relieve either 10 mg of cetirizine, 10 mg of astemizole, or placebo for 4 weeks in a multicenter double-blind trial. Patients rated symptom severity each night, and investigators rated symptoms weekly. RESULTS: One hundred eighty-seven patients were enrolled in the trial; 180 were included in the safety analysis and 177 were included in at least one efficacy analysis. Both cetirizine and astemizole were significantly superior to placebo in relieving symptoms of chronic idiopathic urticaria. Both patients' and investigators' ratings indicated that cetirizine acted more rapidly. Both active treatments were well tolerated, and the incidence of somnolence did not differ statistically between cetirizine (14.5%) and astemizole (10.3%). CONCLUSION: Both cetirizine and astemizole provide effective relief of the symptoms of chronic idiopathic urticaria with similar side-effect profiles. However, clinical benefit occurs significantly more rapidly with cetirizine.

Ciclopirox olamine lotion 1%: bioequivalence to ciclopirox olamine cream 1% and clinical efficacy in tinea pedis.

Studies were conducted to assess the bioequivalence of a new antimycotic formulation, ciclopirox olamine lotion 1%, to an established compound, ciclopirox olamine cream 1%. Results of in vitro studies, using skin samples from human cadavers and domestic pigs, demonstrated that the two formulations equally penetrate all layers of the stratum corneum and inhibit the growth of Trichophyton mentagrophytes and Candida albicans. In vivo studies in guinea pigs and in human volunteers demonstrated the comparable therapeutic efficacy of the lotion and the cream in experimental trichophytosis. In addition, a multicenter, double-blind clinical trial was undertaken to compare ciclopirox olamine lotion 1% with the vehicle alone in the treatment of patients with tinea pedis. Patients with plantar, interdigital, or vesicular tinea pedis were enrolled in the studies. Patients were treated for 28 days. Clinical and mycological responses were determined during treatment and two weeks posttreatment. Ciclopirox olamine lotion 1% was found to be significantly more effective than its vehicle in the treatment of patients with common tinea pedis. Minor localized side effects (pruritus, burning sensation) were reported in 2% of 89 patients treated with ciclopirox olamine lotion 1%. The results demonstrate the bioequivalence of ciclopirox olamine lotion 1% and ciclopirox olamine cream 1% and confirm the clinical effectiveness and safety of the lotion in the treatment of tinea pedis, a generally recalcitrant fungal infection. It is concluded that ciclopirox olamine lotion 1% can be used as an alternative to ciclopirox olamine cream 1% for treatment of tinea pedis, tinea versicolor, tinea cruris, tinea corporis, and cutaneous candidiasis when the convenience and/or cosmetic elegance of a lotion is desired.

Group psychotherapy as an aid in the medical treatment of eczema.

The ongoing management of severe adult eczema is often difficult and problematic for both patient and doctor. A group of ten adult eczema patients were given group psychotherapy as a supplement to their regular medical regimen. Five target symptoms were rated on a biweekly basis first to establish individual baselines of disease course and later to measure treatment effect. The psychologic treatment combined behavioral and cognitive interventions with relaxation training. Patients used multiple self-rating sheets to provide feedback with the goal of increasing their skills in the management of scratching behaviors. At the end of treatment all ten patients showed significant reduction in targeted symptoms.

Naftifine cream 1% versus econazole cream 1% in the treatment of tinea cruris and tinea corporis.

Data from 104 subjects with tinea cruris or tinea corporis were evaluated in this double-blind, randomized study. The subjects applied naftifine cream 1% or econazole nitrate cream 1% to affected areas twice daily for 4 weeks. After 1 week of treatment naftifine had an overall cure rate of 19% compared with 4% for econazole (p = 0.03). A difference in favor of naftifine, although not statistically significant after the first week, persisted throughout treatment. Two weeks after the end of treatment both medications had overall cure rates of approximately 80%. Three percent of the naftifine-treated subjects had side effects compared with 13% of the econazole-treated subjects. In two subjects using econazole, the side effects were severe enough to warrant discontinuation of treatment.

Antimigraine drug interactions with 5-hydroxytryptamine1A receptors.

The interactions of four antimigraine drugs with 5-hydroxytryptamine1A and beta-adrenergic receptors were analyzed in rat brain membranes. Methysergide, cyproheptadine, (-)propranolol, and pizotifen display similar affinities (IC50 values, 83 to 280 nM) for 5-hydroxytryptamine1A receptors labeled by [3H]8-hydroxy-N,N-dipropyl-2-aminotetralin. Cyproheptadine, pizotifen, and methysergide are essentially inactive at beta-adrenergic receptors labeled by [3H]dihydroalprenolol (IC50 values, 8,700 to 87,000 nM). By contrast, (-)propranolol is an extremely potent beta-adrenergic agent (IC50, 3 nM). These data indicate that the 5-hydroxytryptamine1A receptor is a common site of action for (-)propranolol and other antimigraine agents.

Hydrocortisone valerate. Double-blind comparison with two other topical steroids.

Hydrocortisone valerate cream (0.2 percent) was evaluated in three controlled clinical trials involving a total of sixty-eight patients with atopic dermatitis. This new nonfluorinated steroid was found to be as effective as the fluorinated beta-methasone valerate cream (0.1 percent) and significantly more effective than hydrocortisone cream (0.1 percent) and the placebo cream base. All studies were double-blind, paired comparisons, utilizing application of the medications three times a day for up to four weeks or until clearing occurred.