Isoconazole nitrate: a unique broad-spectrum antimicrobial azole effective in the treatment of dermatomycoses, both as monotherapy and in combination with corticosteroids.

Fungal skin infections, or dermatomycoses, are associated with a broad range of pathogens. Involvement of gram-positive bacteria is often suspected in dermatomycoses. Inflammation plays an important role in dermatomycoses, displaying a close association between frequent inflammation and reduced skin-related quality of life. Isoconazole nitrate (ISN) is a broad-spectrum antimicrobial agent with a highly effective antimycotic and gram-positive antibacterial activity, a rapid rate of absorption and low systemic exposure potential. ISN is effective against pathogens involved in dermatomycoses, with minimum inhibitory concentrations well below the concentration of ISN in skin and hair follicles. The combination of the corticosteroid diflucortolone valerate with ISN (Travocort) increases the local bioavailability of ISN. Compared with ISN monotherapy, Travocort has a faster onset of antimycotic action, faster relief of itch and other inflammatory symptoms, improved overall therapeutic benefits and earlier mycological cure rate. Travocort is effective in the treatment of inflammatory mycotic infections, and also in the eradication of accompanied gram-positive bacterial infections. The rapid improvement observed with Travocort treatment, combined with favourable safety and tolerability, results in higher patient satisfaction, and therefore, can be an effective tool to increase treatment adherence in patients with dermatomycoses accompanied by inflammatory signs and symptoms.

Isoconazole nitrate vs isoconazole nitrate and diflucortolone valerate in the treatment of tinea inguinalis: results of a multicenter retrospective study.

BACKGROUND AND OBJECTIVE: Many tinea inguinalis infections are characterized by pronounced inflammatory lesions and pruritus. Therefore, a therapy with a topical corticosteroid in addition to a topical antimycotic agent might be beneficial. In this multicenter, retrospective study, we compared the mycological and clinical efficacy and tolerability of isoconazole nitrate alone vs isoconazole nitrate and diflucortolone valerate in 58 adult patients with tinea inguinalis. PATIENTS AND METHODS: Treatment duration was three weeks. The efficacy of the treatment was based on the assessment of several signs and symptoms, which were collected on a 4-point scale. All patients were examined clinically before the beginning of the treatment, one week later, two weeks later, and at the end of the treatment. Mycological examinations were performed before the beginning of the treatment and at the end of the study. RESULTS: Treatment results with the combination of isoconazole nitrate and diflucortolone valerate were superior regarding erythema and pruritus. Both erythema and pruritus resolved in a larger percentage of patients and more quickly. Both regimens were well tolerated. Mycological cure rates were similar in both groups of patients. CONCLUSIONS: Combination therapy with isoconazole nitrate and diflucortolone valerate is an effective and well-tolerated regimen in adult patients with tinea inguinalis.

Cushing's syndrome and adrenocortical insufficiency caused by topical steroids: misuse or abuse?

BACKGROUND: Prolonged application of topical steroids transiently suppresses the hypothalamic-pituitary-adrenal axis (HPA). Infants who are exposed to topical corticosteroids have greater risk for Cushing's syndrome or adrenocortical insufficiency caused by suppression of the HPA axis because glucocorticoids are highly absorbed through the diaper area. Here, we report six infants (four girls, two boys) aged between 3 and 8 months who were exposed to potent topical corticosteroids (clobetasol propionate and diflucortolone valerate) by the mother's application without prescription. METHODS: We examined the HPA axis and other side effects of the potent glucocorticoid therapy in these infants. After stopping the topical corticosteroid, serum AST, ALT, lipids, morning cortisol and ACTH levels were measured. A low dose ACTH stimulation test was carried out. Hydrocortisone was started for the prevention of glucocorticoid withdrawal syndrome and the dose was gradually decreased. Abdominal ultrasonography was performed to investigate hepatosteatosis. RESULTS: The ACTH stimulation test showed suppression of the HPA axis in these infants. Hepatomegaly was found in all infants and three of them had hepatosteatosis. Liver transaminase levels were elevated in five infants. Five patients have been followed for 6-14 months. One infant died due to generalized Cytomegalovirus infection. CONCLUSION: We emphasize that physicians should be alert for the dangerous side-effects of topical steroids and they should avoid long-term use. Furthermore, parents should be informed about the side-effects when topical steroid treatment is chosen.

Dorsal skin reactions of hairless dogs to topical treatment with corticosteroids.

Dorsal skin reactions to continuous topical treatment with different types of corticosteroids were histologically investigated in hairless descendants of Mexican hairless dogs. The preparations tested were prednisolone (ST-1; weak), fluocinolone acetonide (ST-2; moderate), diflucortolone valrerate (ST-3; strong), and mometasone furoate (ST-4; very strong). Grossly, the sites treated with ST-3 and ST-4 showed moderate inflammatory reactions. After completion of the corticosteroid treatment, both sites were less pigmented and had a thin texture. The severity of histologic changes in the skin was dependent on the efficacy of the corticosteroids. The epidermis was prominently thinned from 1 wk after treatment with the corticosteroids, resulting in a flat dermis-epidermis junction. By the end of the corticosteroid treatment, these lesions became progressively more severe. At 2 wk after completion of topical treatment, the epidermal thickness in the sites treated with ST-1 and ST-2 began to return to normal values, whereas the epidermis of the skin treated with ST-3 and ST-4 became thinner. At 3-4 wk after topical treatment with ST-3 and ST-4, the dermis showed hyalinization of collagen bundles. These dermatologic findings in hairless dogs are in accordance with steroid-induced skin atrophy of human beings. These results suggest that the skin of hairless dogs responds sensitively to topical corticosteroids and that these animals are a useful model for investigating the efficacy and adverse effects of cutaneous topical corticosteroids.

A double-blind, multicenter, parallel-group trial with 0.05% halobetasol propionate ointment versus 0.1% diflucortolone valerate ointment in patients with severe, chronic atopic dermatitis or lichen simplex chronicus.

In a double-blind, parallel-group, multicenter, comparative trial in 120 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, the success rate (described as "healed" and "marked improvement") was 91.5% in patients treated with halobetasol propionate ointment and 83.6% in those in the diflucortolone valerate treatment group. Of patients treated with halobetasol propionate ointment, 40.7% reported healing within 17 days, whereas of those in the diflucortolone valerate treatment group, 32.8% reported healing within that time. Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those treated with diflucortolone valerate ointment (70% versus 59%). Adverse effects at the site of application were less frequently reported in patients belonging to the halobetasol propionate treatment group than in those treated with diflucortolone valerate ointment (3% versus 8%).