Efficacy of itraconazole in the prophylactic treatment of pityriasis (tinea) versicolor.

BACKGROUND: Pityriasis (tinea) versicolor has a high tendency to recur after being treated successfully. Prophylactic treatment to reduce recurrence is needed. OBJECTIVE: To determine whether recurrence of pityriasis versicolor could be prevented by prophylactic itraconazole treatment. DESIGN: Open treatment followed by a randomized, double-blind, placebo-controlled phase. SETTING: Multinational outpatient centers. PATIENTS: A total of 239 consecutive patients were included; 238 started open treatment. A total of 209 patients started prophylactic treatment: 106 in the itraconazole group and 103 in the placebo group. INTERVENTIONS: Open treatment: itraconazole, 200 mg once daily for 7 days. Prophylactic treatment: itraconazole, 200 mg, or placebo twice daily 1 day per month for 6 consecutive months. MAIN OUTCOME MEASURES: Mycological cure rates at the end of open treatment and at the end of prophylactic treatment. RESULTS: Mycological cure at the end of open treatment was 92% (205/223). At the prophylactic treatment end point (6 months), mycological cure was 88% (90/102) in the itraconazole group and 57% (56/99) in the placebo group (P<.001). In open treatment, 11 patients were not able to be evaluated for efficacy. In prophylactic treatment, 4 patients in the itraconazole group and 4 in the placebo group were not able to be evaluated. Adverse events were reported during open treatment by 26 patients (11%) and during prophylactic treatment by 17 (16%) in the itraconazole group and 14 (14%) in the placebo group. No patients experienced any serious adverse events. CONCLUSIONS: Prophylactic itraconazole treatment is efficacious for pityriasis versicolor after 6 months, as is itraconazole in the treatment of pityriasis versicolor.     

Italian multicentre study with oral itraconazole in recurrent pityriasis versicolor, Preliminary report

Pityriasis versicolor is a common mycosis, characterized by frequent recurrences. Oral itraconazole is very effective in the treatment of this infection but there are no published studies on its prophylactic use. The purpose of our study was to assess further the efficacy of itraconazole in the treatment of recurrent pityriasis versicolor and to investigate its role in prophylaxis. In this ongoing study, 270 patients with recurrent pityriasis versicolor receive 200 mg itraconazole once daily for seven days. Those who experience clinical and mycological cure, sustained one month after the end of treatment, then enter the prophylactic phase of the study and receive either 200 mg itraconazole or two placebo capsules once a month for five months. Of the 48 patients who so far have received the full seven days' treatment with itraconazole, 31 have completed the first phase of the study. Complete clinical cure was achieved in 30(96%) and residual lesions persisted in one. Mycological cure was achieved in all. No adverse events were reported. Nine patients have now entered the prophylactic phase (five taking itraconazole and four placebo). No symptoms so far have reappeared in any of them. Oral itraconazole is a highly effective and well-tolerated treatment for recurrent pityriasis versicolor. The role of itraconazole in prophylaxis is still undetermined pending completion of the study.     

Itraconazole, a new orally active antifungal, in the treatment of pityriasis versicolor

Itraconazole, a new orally active triazole antifungal, has been tested in patients with pityriasis versicolor. A comparison of different dose schedules was carried out in 73 patients. A regime of 100 mg itraconazole daily for 15 days gave a 100% response rate; 200 mg daily for 5 days gave an 80% response rate. Two patients, who had received 50 mg itraconazole for 14 days, relapsed within 2 months of finishing treatment. Only two patients reported minor side-effects.     

Oral itraconazole therapy for pityriasis versicolor

The therapeutic efficacy and safely of oral itraconazole (200 mg/day for 7 days) was assessed in an open trial in 50 patients with pityriasis versicolor. At the end of the I-week therapy complete remission and marked improvement were observed in 44% and 48% of the treated patients, respectively: 8% of the patients who showed no response were treated for 1 more week and also revealed a complete remission by the end of she 3-week follow-up (50/50). Headache and/or nausea occurred in 6% of the patients, whereas, the haematological and biochemical investigations revealed no abnormalities. The results of the present study clearly indicate that oral itraconazole is a highly efficacious and safe treatment for pityriasis versicolor.     

伊曲康唑巩固疗法降低花斑癣复发率的临床研究

目的:探讨一种能够降低花斑癣复发率的有效治疗方案。方法:将初诊的花斑癣患者按就诊时间分为两组,均口服伊曲康唑0.2g,每日1次,连续服药7d。7d后对照组停药观察,试验组则继续服用伊曲康唑,每月口服0.2g1次,共6个月。两组患者皆每月复诊1次,共6次。结果:试验组99例患者复发率为1.01%,治愈率为85.86%。对照组95例患者复发率为17.89%,治愈率为64.21%。经卡方检验两组患者的复发率及治愈率相比,差异均有极显著性(χ2=16.4195,P=0.0001和χ2=12.2013,P=0.0005)。结论:巩固治疗方案能在近期内降低花斑癣复发率,同时提高花斑癣的治愈率。     

Short term treatment of pityrosporum folliculitis with itraconazole

We compared the efficacy and safely of short-term itraconazole with that of placebo in 26 patients of pityrosporum folliculitis. Twenty-six patients of mycologically proven pityrosporum folliculitis entered a double-blind placebo-controlled trial. Patients were randomly assigned to 7 days of treatment with either itraconazole, 200 mg once daily, or placebo. A global clinical assessment and mycological examination (KOH and smear examination) were performed at baseline and at 4 weeks after treatment. In this study, itraconazole in a dose of 200 mg for 7 days produced a distinct and statistically significant improvement over placebo (p<0.01). 84.6% of itraconazole treated patients were considered to be healed or markedly improved at the study's end point compared with 8.3% of placebo treated group (p<0.01). Eighty-four percent of patients receiving active treatment showed negative mycological examination as compared to 8.3% of placebo-treated group (p<0.01). Short-term treatment with itraconazole is effective and well tolerated in the management of pityrosporum folliculitis.     

Double-Blind Comparison of Itraconazole with Griseofulvin in the Treatment of Tinea Corporis and Tinea Cruris

Seventy-eight patients with tinea corporis or tinea cruris participated in a double-blind study with either 100 mg itraconazole or 500 mg ultramicronized griseofulvin for 15 consecutive days. Clinical outcome was significantly in favor of itraconazole at completion of treatment (72% response rate vs. 51%) and at the follow-up visit (91% response vs. 64%). The most important difference between both treatments was the mycologic outcome, for which itraconazole showed a cure rate of 87% compared to 57% for griseofulvin 2 weeks after completion of therapy. It is suggested that 100 mg of itraconazole orally once daily is significantly more effective than 500 mg of griseofulvin once daily for 15 days in the treatment of glabrous skin infections. Both drugs were well tolerated.     

Fluconazole and itraconazole in pityriasis versicolor

Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species. It has a high incidence and prevalence in tropical climates. Although it responds well to treatment, relapses and recurrences are frequent. In the present study the therapeutic response of single dose fluconazole (400 mg) with itraconazole (100mg twice daily ? 7 days) was compared in sixty patients of pityriasis versicolor. No significant statistical difference (p>0.05%) was observed between efficacy of two drugs. Therapy with fluconazole is preferable in view of single dose administration and lesser cost as compared to itraconazole.     

Itraconazole compared with griseofulvin in the treatment of tinea corporis/cruris and tinea pedis/manus: an interpretation of the clinical results of all completed double-blind studies with respect to the pharmacokinetic profile.

Itraconazole is an orally active triazole antifungal which has been compared to griseofulvin in a number of double-blind trials. In dermatophytosis with a non-fixed treatment regimen for a maximum of 3 months, itraconazole 100 mg o.d. has produced a 100% mycological cure rate as compared with a 67% rate with griseofulvin 500 mg o.d. (p less than 0.01). Based on the pharmacokinetic profile, 100 mg itraconazole daily was then compared with 500 mg ultramicronized griseofulvin daily using a fixed treatment schedule of 15 days in tinea corporis and/or cruris and 30 days in tinea pedis and/or manus. In all studies in tinea corporis/cruris (n = 277), the superiority of itraconazole was shown for the clinical outcome at the last follow-up visit 2 weeks post-therapy (88 vs. 69%, p less than 0.01) and in the mycological outcome at the last follow-up visit (81 vs. 65%, p less than 0.05). In tinea pedis/manus (n = 210), the clinical response was virtually the same for the two treatment groups, but the most important finding was the mycological outcome with a significantly better result in favor of itraconazole at the end of treatment (77 vs. 61%, p less than 0.05) even more pronounced at the follow-up visit (85 vs. 48%, p less than 0.01). We conclude that itraconazole 100 mg daily in the treatment of tinea corporis/cruris and in tinea pedis/manus is significantly more effective than 500 mg griseofulvin daily when fixed treatment regimens are used. Furthermore, the best results are obtained with itraconazole 2-3 weeks after the end of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)     

Single-dose fluconazole versus itraconazole in pityriasis versicolor

BACKGROUND: The new antifungal triazoles itraconazole and fluconazole have revolutionized the treatment of pityriasis versicolor. Both drugs have shown promising results in different dose schedules. OBJECTIVE: To compare the efficacy and safety of single oral dose treatment with fluconazole versus itraconazole in patients with pityriasis versicolor. METHODS: A total of 40 patients with pityriasis versicolor were allocated randomly to group A and group B. A single dose of fluconazole (400 mg) or itraconazole (400 mg) was given orally to group A or group B patients, respectively. Patients were assessed mycologically by KOH and culture. Culture was done from lesional and perilesional skin to quantify growth and to observe the effect of these drugs and the persistence/reappearance of the fungus in relation to relapse at 2 and 8 weeks. Relapse was defined as reappearance or worsening of clinical signs and symptoms or positive KOH/culture after initial improvement. RESULTS: Thirteen (65%) patients in the fluconazole group and 4 (20%) patients in the itraconazole group became culture negative at the end of 8 weeks. Relapse was found to be higher in the itraconazole group compared to the fluconazole group (60 vs. 35%). A direct correlation was found between the relapse rate and positivity of perilesional skin for Malassezia furfur. CONCLUSION: In the same dosing, fluconazole was found to be more effective than itraconazole; however, both drugs were found to be safe.     

Short course ketoconazole therapy in pityriasis versicolor

Treatment regimes for pityriasis versicolor consisting of 5, 15 or 25 days of ketoconazole (200 mg daily) were compared in a blind study. There were no differences in the cure or relapse rates with these treatment regimes. Overall cure rates 6 weeks after therapy ranged from 78% to 90%. Treatment with a daily 200 mg tablet of ketoconazole for 5 days can be used for most cases of pityriasis versicolor with longer periods of oral therapy being reserved for resistant cases. Short course ketoconazole will need to be compared against alternative topical forms of antifungal therapy.     

A randomized, double-blind, placebo-controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis

BACKGROUND: Several modalities have been used for the treatment of cutaneous leishmaniasis (CL) with various results. In vitro and in vivo studies have shown inhibitory effects of azole drugs on Leishmania parasites. OBJECTIVES: To evaluate the efficacy and tolerability of oral itraconazole in the treatment of CL caused by L. major. METHODS: A total of 200 patients with parasitologically confirmed CL with a duration of less than 45 days from a well known L. major endemic area were included in a randomized, double-blind, placebo-controlled clinical trial. The patients received either itraconazole 200 mg daily (100 patients) or placebo (100 patients) for 8 weeks. The primary outcome measures were clinical cure (complete re-epithelization of all lesions) and parasitological cure at the end of the treatment. RESULTS: Eighty-three patients in the itraconazole and 75 patients in the placebo group completed the treatment course. After 8 weeks of treatment, clinical cure was observed in 59% and 53% and parasitological cure was observed in 83% and 76% of patients in the itraconazole and placebo groups, respectively, which were not significantly different. There was no difference in the rate of adverse events. CONCLUSIONS: An 8-week course of oral itraconazole was not more effective than placebo in the treatment of CL.     

Short course bifonazole therapy in pityriasis versicolor

Ninety patients were randomly assigned to one of three treatment regimens for pityriasis versicolor consisting of a once daily application of bifonazole 1% solution for a single day, 2 days (day one and day three) or 3 days (day one, day three and day six). Overall clinical cure rates 3 weeks after the end of therapy ranged from 69·9% to 89·9%. Statistical analysis showed a significant difference (p 0·04) in favour of three days therapy at the assessment three weeks and 90 days after the etui of therapy. Short-term therapy with three applications of bifonazol seems to be effective in most cases of pityriasis versicolor, and needs to be compared against alternative forms of antifungal therapy.     

Treatment of head and neck dermatitis comparing itraconazole 200 mg and 400 mg daily for 1 week with placebo

BACKGROUND: Head and neck dermatitis (HND) is a variant of atopic dermatitis often seen in young adults. A hypersensitivity to Malassezi antigens is considered to be of pathogenic importance. Previous mostly uncontrolled studies have shown that oral antimycotics might be of use in this condition. OBJECTIVE: To evaluate the efficacy of itraconazole in the treatment of HND in a randomized, double-blind, placebo-controlled trial. PATIENTS: Adult patients with HND were included. Systemic steroids and oral/topical antimycotics were avoided 1 and 2 months prior to the trial. Topical steroids were not allowed in the head and neck area within 2 weeks. Patients in generally good health were included and female patients had to have had a negative urine pregnancy test. The patients signed an informed consent. STUDY DESIGN: The study included a 7-day treatment period and a follow-up period of 105 days. Control visits were carried out on days 3, 7 and 14 and after 15 weeks. METHODS: The SCORAD index (one for the head and neck area and one for the remaining surface area) and global evaluations by patient and investigator were used for clinical evaluation at each visit. Prick tests with Malassezia antigens and Candida albicans antigen were carried out at the start of the trial and included positive and negative controls. The patients were randomized into three groups, which were treated with 400 mg itraconazole daily, 200 mg itraconazole daily or placebo, respectively, for 7 days. RESULTS: The number of patients included was 53: 18 had 200 mg itraconazole daily, 17 had 400 mg itraconazole daily and 18 placebo. At days 7 and 14, significant improvement was seen in the SCORAD of the head and neck area for the groups given 400 mg itraconazole daily (P = 0.0385 and P = 0.0134), and 200 mg daily (P = 0.0104 and P = 0.0006). Patients in the placebo group improved slightly (P = 0.0785). At day 14, comparison of improvement of SCORAD of the head and neck area between all three groups showed a significant difference in favour of the 200 mg itraconazole group compared to the placebo group (P = 0.0318). The prick test was positive for Pityrosporum ovale in 37% and negative for C. albicans in all patients. CONCLUSIONS: One week of treatment with 200 or 400 mg itraconazole as a single treatment has a significant effect on the head and neck area. Compared to placebo there was a significant improvement in SCORAD of the head and neck area in favour of the 200 mg itraconazole group after 14 days. The important observation seems to be that antifungal systemic treatment has a significant SCORAD reduction of atopic dermatitis, irrespective of the presence of allergy.     

Italian multicentre trial comparing itraconazole with griseofulvin in the treatment of dermatomycoses. Preliminary results

The results of previous international studies have suggested that itraconazole is significantly superior to griseofulvin in the treatment of tinea corporis/cruris. The aim of our study was to compare the efficacy and tolerability of the two agents in a larger number of patients with dermatomycoses. This study is ongoing in 46 Italian Centers of Dermatology. From this total of 46 Centers, the patients of 16 Centers have been included for the "ad interim" analysis. One hundred and thirty-four patients were randomized to treatment with either itraconazole 100 mg once daily for 15 days (73 patients) or griseofulvin 375–1000 mg daily for a mean of 17 days (61 patients). The patients were assessed clinically and mycologically before entering the trial, at the end of therapy and again 30 days after the end of treatment. Both groups showed a statistically significant improvement in desquamation, erythema and subjective complaints, with a trend in favour of itraconazole, despite the significantly shorter duration of treatment. Thirty days after the end of therapy, microscopic results were negative in 91.5% of the itraconazole group and 71.7% of the griseofulvin group. Cultures were negative in 80% and 65%, respectively. A significantly higher proportion of patients in the itraconazole group than in the griseofulvin group experienced both clinical and mycological recovery. One patient in the itraconazole group and three in the griseofulvin group reported adverse experiences. The preliminary results of this study show that itraconazole is well tolerated and more effective than griseofulvin. Furthermore, itraconazole demonstrated a more rapid action than griseofulvin.     

Fluconazole vs. Itraconazole in the treatment of tinea versicolor

Ninety patients with tinea versicolor were randomly assigned to treatment with either a single 450-mg dose of fluconazole, two 300-mg doses of fluconazole given 1 week apart, or itraconazole 200 mg daily for 7 days. At the end of treatment, the cure rate for itraconazole (20%) was significantly higher ( P  = 0.024) than that for fluconazole 450 mg (0%). When cure plus improvement was considered, response rates among the three treatment groups were comparable (97, 100, and 97% for fluconazole 450 mg, fluconazole 300 mg, and itraconazole, respectively). Failure rates at the end of treatment were low (0–3%). Clinical response rates achieved at the end of treatment generally were maintained at 1 month, but tended to decrease at 2 months. Eradication at the end of treatment was not significantly different among the treatment groups (17, 33, and 38% for fluconazole 450 mg, fluconazole 300 mg, and itraconazole, respectively). At 1 month, the eradication rate was significantly higher ( P  = 0.012) for the two-dose than the single-dose fluconazole treatment group (97 and 70%, respectively). At 2 months, reinfection rates were 21, 20, and 4% for fluconazole 450 mg, fluconazole 300 mg, and itraconazole, respectively. No clinical adverse events occured, and no patients were withdrawn for laboratory abnormalities.     

Efficacy of itraconazole in the treatment of tinea versicolor

Twenty adult patients (15 males and 5 females) with extensive, clinically diagnosed tinea versicolor (TV.) resistant to topical agents, of long duration were selected. Laboratory investigations like KOH smear, routine haemogram, LFT, and RFT were done. They were given itraconazole (100 mg) orally twice daily for 5-7 days and followed up at the end of 1 week and again three weeks later. After one week itching, erythema and scaling subsided in 80% of cases. There was no recurrence during one year follow up.     

Disruption of barrier function in dermatophytosis and pityriasis versicolor

Dermatophytes have the ability to form molecular attachments to keratin and use it as a source of nutrients, colonizing keratinized tissues, including the stratum corneum of the skin. Malassezia species also affect the stratum corneum of the skin. Therefore, dermatophytosis and pityriasis versicolor of the skin are thought to be important factors of profound changes in skin barrier structure and function. We aimed to describe the changes in transepidermal water loss (TEWL), stratum corneum hydration, and skin pH in the lesions of the dermatophytosis and pityriasis versicolor. Thirty-six patients with dermatophytosis (14 with tinea cruris, 13 with tinea corporis and nine with tinea pedis or tinea manus) and 11 patients with pityriasis versicolor were included in this study. TEWL, stratum corneum conductance and skin pH were determined by biophysical methods to examine whether our patients exhibited changes in barrier function. Dermatophytosis and pityriasis versicolor except tinea pedis and tinea manus showed highly significant increase in TEWL compared with adjacent infection-free skin. Hydration was significantly reduced in lesional skin compared with adjacent infection-free skin. From this study, infections with dermatophytes and Malassezia species on the body can alter biophysical properties of the skin, especially the function of stratum corneum as a barrier to water loss. On the contrary, infections with dermatophytes on the palms and soles little affect the barrier function of the skin.     

Comparative study of miconazole and clotrimazole in superficial mycosis

Two hundred cases of superficial mycosis (100 dermatophytosis, 40 candidiasis and 60 pityriasis versicolor) were studied for the comparative effect of miconazole and clotrimazole. The patients were evaluated both clinically and mycologically every 2 weeks for a period of 12 weeks. In dermatophytosis, miconazole showed accelerated response (75% cleared in 6 weeks) than clotrimazole (56%). In candidiasis, both were found to be effective (80-85%) cure though clotrimazole showed slightly earlier response (40% cure in 6 weeks) against miconazole (30% cure). In pityriasis versicolor both were, effective (miconazole 99.6% and clotrimazole 86.7%).     

Atrophying Pityriasis Versicolor: Is This a New Variant of Pityriasis Versicolor?

An atypical clinical form of pityriasis versicolor has been infrequently reported, in which cutaneous atrophy is associated with individual pityriasis versicolor lesions. The pathogenesis of this atrophy remains unclear, but is believed to be a delayed-type hypersensitivity reaction to antigens derived from the Malassezia species. A 60-year-old man presented with multiple, slightly scaly, and depressed maculopatches or plaques on the trunk and extremities. Our microscopic examination of the skin scrapings on a KOH preparation revealed numerous short hyphae and spores. The patient was treated daily with 200 mg of itraconazole in combination with topical antifungals, achieving clinical improvement and mycological recovery, which was confirmed upon follow-up 1 month later. This is the first case report of atrophying pityriasis versicolor in Korea. It needs to be differentiated from other atrophying disorders of the skin.