Itraconazole versus terbinafine (LAMISIL®): which is better for the treatment of onychomycosis?

Objectives To compare the efficacy, safely and tolerability of oral terbinafine with itraconazole in patients with toenail onychomycosis treated for 4 months. Setting Departments of dermatology of six universities and one private clinic. Design Double-blind double-dummy, multicentric, multinational, parallel-group therapeutic trial, involving 179 patients with toenail onychomycosis. Patients were randomly treated with either 200 mg/day oral itraconazole or 250 mg/day terbinafine for 4 months. After the 4th month both treatment groups received oral placebo for another 8 months. The total duration of the study was therefore 12 months. After the 12th month a final evaluation of efficacy was performed in 167 patients (85 on itraconazole and 82 on terbinafine) and a final evaluation of tolerability was performed in 175 patient. Results The dermatophytes identified at the initial visit were Trichophyton rubrum (82.1%), Trichophyton mentagrophytes (14%) and others (3.9%), The mycological cure rates at the end of the 4th and 12th months were 54.9% and 95.3% in the terbinafine group and 51.8% and 84.31% in the itraconazole group (the difference between the groups was. statistically significant at the 12th month, P < 0.04). Clinical cure was achieved by 8.5% and 9.4% of the patients in the terbinafine and itraconazole groups at the 4th month (not significant. NS) and these rates increased to 57.8% and 62.9%. respectively, at the 12th month (difference between groups NS, P > 0,05). A complete mycological cure associated with clinical improvement over 50%. was observed at the 4th month in 50% of the patients treated with terbinafine and 49.4% of the patients treated with itraconazole which was not statistically significant (NS). At the 12th month the rates increased to 95.4% with terbinafine and 75.7% with itraconazole (statistically significant. P < 0.001). Seven patients of the terbinafine group and 9 patients of the itraconazole group presented drug-related side effects (NS). Six patients (6.3%) discontinued the study due to adverse events in the itraconazole group hut no patient discontinued in the terbinafine group. At entry into the study all subjects in both groups presented normal values in liver function tests which remained unchanged throughout the study in the patients of the terbinafine group. One patient of the itraconazole group presented small increases in SGOT and SGPT associated with abdominal pain and nausea.     

Oral itraconazole for the treatment of seborrhoeic dermatitis: an open, noncomparative trial

BACKGROUND: Seborrhoeic dermatitis is an inflammatory cutaneous disorder in which the colonization of the affected area by Malassezia has been proved to play a key role. OBJECTIVE: To perform a noncomparative open clinical study with oral itraconazole capsule (200 mg/day x 7 days) and consecutive usage 200 mg/day for the first 2 days of the following 2 months in patients with seborrhoeic dermatitis. METHODS: Twenty-nine patients were enrolled to determine the efficacy and safety of oral itraconazole. The patients were evaluated according to itching, burning, erythema, desquamation and seborrhoea, each scored on a 0-4 scale on days 15 (T15), 30 (T30), 60 (T 60) and 90 (T90). Itraconazole capsule 100 mg was given twice a day for 1 week and then, after a 3-week interval, patients used itraconazole capsule 200 mg/day for the first 2 days of the following 2 months. The clinical response was graded as markedly effective, effective, moderate or ineffective. RESULTS: A clinical improvement (evaluated as markedly effective or effective) was observed in 23 patients (83%) at T15, 21 (76%) at T30, 20 (72%) at T60 and 17 (61%) at T90. At baseline, the mean +/- SD total clinical scores were 10.44 +/- 2.45, 1.98 +/- 0.5, 2.97 +/- 1.12, 3.15 +/- 1.74 and 3.30 +/- 1.90 at T0, T15, T30, T60 and T90, respectively. Compared with baseline values, itraconazole capsule significantly reduced the mean +/- SD total score as well as individual erythema and desquamation (Wilcoxon's signed test-two tailed) (P < 0.0001). No drug-related systemic adverse event was observed during the study. CONCLUSIONS: Seborrhoeic dermatitis shows marked reduction in inflammation when treated with itraconazole. The anti-inflammatory activity of oral itraconazole and efficacy on Malessezia suggests that itraconazole capsule will be first oral treatment option in future in severe seborrhoeic dermatitis.     

Itraconazole in the treatment of New World mucocutaneous leishmaniasis

BACKGROUND: A well-tolerated oral drug is required for the treatment of mucocutaneous leishmaniasis (MCL). Current parenteral treatment regimens with pentavalent antimonials are associated with marked toxicity and significant rates of relapse. AIM: To evaluate the efficacy and tolerability of high-dose itraconazole for the treatment of MCL. METHODS: An uncontrolled treatment study was performed in 13 Ecuadorian patients with MCL. Each patient received a daily dosage of 400 mg of itraconazole for a minimum of 3 months. RESULTS: All 13 subjects responded to itraconazole during the first month of treatment, but by 12 months after treatment the complete resolution of MCL lesions was observed in only three (23%) subjects. No adverse effects of treatment were reported. Response to treatment was associated with a short evolution of the disease and mild to moderate disease severity. CONCLUSION: Prolonged and high-dose treatment regimens with itraconazole are not effective for the treatment of the majority of patients with MCL.     

Systematic Review of Oral Treatments for Seborrheic Dermatitis

Seborrheic dermatitis (SD) is normally treated with topical corticosteroids and antifungals. Oral therapies can be prescribed in severe or unresponsive cases. This review aims to assess the quantity and quality of published reports on oral therapies for SD. MEDLINE and Embase databases and the reference listings of publications were searched for any publication using oral treatment for SD. The quality of the included publications was assessed using a modified 27 item checklist by Downs and Black. Twenty‐one publications (randomized controlled trials, open trials and case reports) covering eight oral therapies (itraconazole, terbinafine, fluconazole, ketoconazole, pramiconazole, prednisone, isotretinoin and homeopathic mineral therapy) were identified. Most of the publications investigated oral antifungals and the quality of the evidence was generally low. The clinical efficacy outcome reported varied considerably between the studies, preventing statistical analysis and direct comparison between treatments. However, ketoconazole therapy was associated with more relapses compared with other treatments. Itraconazole dosing regimen for SD was generally 200 mg/day for the first week of the month followed by 200 mg/day for the first 2 days for 2–11 months. Terbinafine was prescribed at 250 mg/day either as a continuous (4–6 weeks) or as an intermittent regimen (12 days per month) for 3 months. Fluconazole has administered daily (50 mg/day for 2 weeks) or weekly (200–300 mg) for 2–4 weeks. Ketoconazole dosing regimen was 200 mg daily for 4 weeks. Finally, a single 200 mg dose of pramiconazole was administered to patients. This review also highlights key areas for consideration when designing future studies.     

Oral itraconazole for the treatment of severe seborrhoeic dermatitis

Background:

Seborrheic dermatitis (SD) is an inflammatory skin disorder in which colonies of Malassezia furfur have been found in affected areas.

Aim:

The aim of this study was to evaluate the efficacy of itraconazole in the treatment of severe SD.

Materials and Methods:

Itraconazole was given to 30 patients of SD in a dose of 100 mg twice daily for 1 week followed by 200 mg/day for first 2 days of the following 2 months. The response was noted on day 15, 30, 60, and 90. The clinical response was graded as markedly effective, effective, or ineffective.

Results:

Clinical improvement (evaluated as markedly effective or effective) was observed in 83.3% cases.

Conclusion:

The anti-inflammatory activity of oral itraconazole suggests that it should be the first-line therapy in severe SD.     

Combined 0.1% retinaldehyde/ 6% glycolic acid cream in prophylaxis and treatment of acne scarring

BACKGROUND: Acne often results in permanent, badly tolerated, difficult to treat scars. OBJECTIVE: To evaluate the efficacy and safety of a 0.1% retinaldehyde/6% glycolic acid (RALGA) cream at preventing and treating acne scarring in patients previously treated for moderate acne. METHODS: A double-blind vehicle-controlled study was conducted in 145 patients randomized to apply RALGAor vehicle cream every evening for 3 months. Global scarring score and patient's assessment of global efficacy, then residual acne lesions, quality of life and tolerance were evaluated at inclusion and each month until study completion. RESULTS: Global scarring score, number of inflammatory lesions and comedones significantly improved in each group from day 28 (p<0.0001). Number of inflammatory lesions were significantly decreased only in the RALGA group. RALGA cream was more efficient than vehicle on scarring after 3 months in compliant patients (p=0.007) due to erythema and hyperpigmentation improvement. CONCLUSION: RALGA cream is efficient at preventing and treating acne scarring in patients with moderate acne.     

A comparison of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in pediatric atopic dermatitis patients who failed to respond to hydrocortisone

Two hundred and nineteen patients completed this multicenter, randomized, evaluator-blind, parallel-group study evaluating the efficacy and safety of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in children with moderate to severe atopic dermatitis. Enrolled patients were between 2 and 12 years of age and had failed to respond to at least 7 consecutive days of treatment with a topical hydrocortisone preparation, with the last application of hydrocortisone occurring within a week before enrolling in the current study. Patients were randomized to treatment from 10 centers in the USA with either mometasone furoate 0.1% cream (n = 109) or hydrocortisone valerate 0.2% cream (n = 110) for up to 3 weeks. At enrollment, a target area of dermatitis (not the face or forehead) of at least 20 cm² was selected by the investigator for specific evaluation of the effects of treatment on disease signs and symptoms. Additionally, patients had to present with at least 15% total body surface involvement, excluding the face and forehead, with the current exacerbation of atopic dermatitis. The severity of erythema, induration/lichenification, scaling/crusting, exudation, excoriation, and pruritus was graded on the following scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe. A total sign/symptom severity score (sum of six individual sign/symptom severity scores) of ≥ 8 was required in the target area (maximum = 18), with a severity score of ≥ 2 required for erythema and for one other sign. Patients were examined on return visits on days 4, 8, 15, and 22 of treatment and the severity of the signs and symptoms present in the target area was rated by the investigator at each visit. Areas outside the target area were also treated with the study medications and evaluated by the investigator in the global response to treatment. The criteria for global clinical response compared to baseline were as follows: cleared (100% improvement); excellent (75–99% improvement); good (50–74% improvement); fair (25–49% improvement); poor (< 25% improvement); exacerbation (a flare-up at a treatment site). No other therapies for atopic dermatitis were permitted.     

Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood

OBJECTIVES: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus and to assess its tolerance. DESIGN: Double-blind randomized trial with placebo control. SETTING: Outpatients of the Department of Dermatology, University Hospital of Nice, from December 21, 2004, to April 19, 2005. PATIENTS: Fourteen consecutive patients with oral erosive lichen planus confirmed by histological examination and with a clinical score superior to 3. Of the 14 patients, 2 did not meet the inclusion criteria and 12 were enrolled in the trial. INTERVENTION: The intervention was 1% pimecrolimus cream or its vehicle, which was applied on ulcerated lesions twice a day for 4 weeks. MAIN OUTCOME MEASURES: The efficacy of the treatment was quantified using a 12-point clinical score. The blood level of pimecrolimus was analyzed on days 0 (baseline), 14, and 28. RESULTS: In the placebo group, the mean score was 4.67 on day 0 vs 3.33 on day 28 (P = .22). In the pimecrolimus group, the mean score was 6.83 on day 0 vs 3.33 on day 28 (P = .04). In the pimecrolimus group, blood concentrations of pimecrolimus were always above the threshold (mean value, 2.84 ng/mL; extreme values, 0-6.19 ng/mL). Pimecrolimus cream was well tolerated, and only transient burning sensations were reported by some subjects. Each of the patients in the pimecrolimus group whose condition improved subsequently relapsed when assessed 1 month after treatment. CONCLUSIONS: The 1% pimecrolimus cream seems to be an effective and well-tolerated treatment for oral erosive lichen planus. The finding of systemic levels of pimecrolimus after mucosal applications necessitates long-term study because it seems that long-term application is required to maintain clinical improvement.     

Itraconazole oral solution for the treatment of tinea capitis

Twenty-seven children (12 boys, 15 girls, age range 3–11 years, weight range 10–40 kg) were treated with itraconazole oral solution 10 mg/mL given as pulse therapy for tinea capitis. The dosage regimen was 3 mg/kg per day given once daily in a fasting state with each pulse lasting 1 week. The first two pulses were separated by a 2-week off-drug period, and the second and third pulses had a 3-week period without drug between them. For each patient a second and third pulse were administered if there was clinical evidence of tinea capitis at the time-point when the next pulse was due. The overall severity of tinea capitis at pretherapy was classified as mild, moderate or severe with the aetiology being: Trichophyton tonsurans , 24 patients; T. violaceum , two patients and Microsporum canis , one patient. In 19 evaluable patients, 12 weeks after starting therapy, the numbers of pulses of itraconazole oral solution required to produce complete cure were, according to the severity of disease, mild tinea capitis (one pulse: four patients; two pulses: five), moderate disease (one pulse: two patients; two pulses: two; three pulses: two), and severe disease (three pulses: three patients). One patient with moderate severity tinea capitis was clinically clear after three pulses of therapy but mycological examination was positive. Seven patients were lost to follow-up and one discontinued therapy because of nausea. Itraconazole oral solution 3 mg/kg per day was generally well tolerated. Three children developed gastrointestinal adverse effects which were considered to be minor or 'nuisance' effects. The data from this preliminary report need to be confirmed in a larger group of patients. It remains to be seen whether itraconazole oral solution will become a practical alternative to the antifungal agents available in a liquid preparation for the treatment of tinea capitis.     

Nasal Cutaneous Infection in a Healthy Boy Caused by Fusarium moniliforme

A healthy 10‐year‐old Chinese boy developed verrucous plaques on the nose. The fungus was identified as Fusarium moniliforme via culture of biopsy fragments. The patient had normal immune status and was successfully treated with oral itraconazole (100 mg/day) for 2 months and application of oral itraconazole and topical sertaconazole nitrate cream. Fusarium is a ubiquitous hyalohyphomycete isolated from food that is also widespread in the environment and is present at all latitudes. Infections due to this mold may be disseminated or localized. Fusarium species have been known to colonize the cornea, nails, and burn eschars in otherwise healthy patients. Cutaneous and disseminated infections have been reported mostly in immunocompromised hosts. Here we describe an unusual case of localized infection caused by Fusarium moniliforme in an otherwise healthy child, with significant improvement after 2 months of oral itraconazole and topical sertaconazole nitrate cream therapy.     

A randomized trial of amorolfine 5% solution nail lacquer in association with itraconazole pulse therapy compared with itraconazole alone in the treatment of Candida fingernail onychomycosis

BACKGROUND: Treatment failures and relapses are not uncommon in onychomycosis. Therefore, it is worthwhile to consider the combination of systemic and topical antifungals to improve the cure rates further and to reduce the duration of systemic treatment. OBJECTIVES: To evaluate and compare itraconazole pulse therapy combined with amorolfine with itraconazole alone in the treatment of Candida fingernail onychomycosis. METHODS: Ninety patients with moderate to severe Candida fingernail onychomycosis were randomized into two treatment groups of 45 subjects each. Group 1 received itraconazole pulse therapy for 2 months and applied amorolfine 5% solution nail lacquer for 6 months, while group 2 received monotherapy with three pulses of itraconazole. The primary efficacy criterion was the result of mycological examination at 3 months. The secondary criterion was the combined mycological and clinical response at 9 months. A pharmacoeconomic analysis was also performed to compare the cost-effectiveness of combined therapy vs. monotherapy. RESULTS: Eighty-five patients were analysed (73 women and 12 men, mean +/- SD age 44.2 +/- 12.9 years). Patients had a mean +/- SD of 3.64 +/- 2.0 nails involved and 228.6 +/- 148.0 mm2 of their nail surface diseased. The mean duration of onychomycosis was 11 months. Paronychial involvement was evident in 71 patients. C. albicans was isolated in 85 cases, C. parapsilosis in three and other Candida species in two cases. Side-effects were uncommon and in only one case led to withdrawal. At the 3-month visit, mycological cure was seen in 32 (74%) of 43 patients in group 1 and in 25 (60%) of 42 patients in group 2. At the 9-month visit, a global cure was seen in 40 patients (93%) in group 1 and in 34 patients (81%) in group 2. Statistical analysis showed no statistically significant difference (P > 0.1) between the two treatment groups. The cost per cure ratio was 1.63 and 1.70euro for groups 1 and 2, respectively. CONCLUSIONS: The combination of amorolfine and oral itraconazole, which interfere with different steps of ergosterol synthesis, exhibited substantial synergy. Compared with oral itraconazole alone, the combination achieved greater mycological cure and increased total cure rate. However, no statistically significant difference was documented for this number of observations. Combination treatment with amorolfine and two pulses of itraconazole is at least as safe and effective as three pulses of itraconazole, with a lower cost per patient. In our opinion, the addition of amorolfine to oral itraconazole pulse therapy is of value in the treatment of moderate to severe Candida fingernail onychomycosis.     

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.     

The value of chronic suppressive therapy with itraconazole versus clotrimazole in women with recurrent vaginal candidiasis.

OBJECTIVE--To determine the comparative efficacy of oral itraconazole versus intravaginal clotrimazole in suppressing recurrent episodes of vulvovaginal candidiasis. DESIGN--Prospective randomised open study of women with recurrent vulvovaginal candidiasis. Clinical and microbiological assessments were made monthly for 12 months. SETTING--Women's Clinic of a University teaching hospital. SUBJECTS--Forty-four otherwise healthy, non-pregnant women, with at least four proven episodes of candida vaginitis in the last year were enrolled into the study. INTERVENTION--After an acute episode of candida vaginitis, 22 women received oral itraconazole 200 mg daily for five days, then 200 mg twice weekly for six months; and 22 women received intra-vaginal clotrimazole 200 mg ovules daily for five days, then 200 mg twice weekly for six months. MAIN OUTCOME MEASURES--Symptomatic recurrent clinical vulvovaginal candidiasis during the first six months of suppressive therapy was the major endpoint. A secondary endpoint was recurrent candida vaginitis within six months after completion of therapy. RESULTS--Six patients did not complete the study, one in the itraconazole group and five in the clotrimazole group. Of the evaluable patients, seven of 21 patients (33.3%) in the itraconazole group versus none (0%) of 17 patients on clotrimazole were failures on suppressive therapy, p = 0.02. Following discontinuation of suppressive therapy, recurrences of candida vaginitis were similar, 10 (47.6%) of patients on itraconazole (95% confidence interval (CI) 27-67%), versus 11 (64%) patients on clotrimazole (CI 41-87%), p = 0.15. CONCLUSION--Intermittent suppressive therapy with clotrimazole was more effective than itraconazole in preventing recurrent candida vaginitis, provided patients adhered to the regimen. Recurrence of vaginitis was common with both regimens after stopping suppressive therapy.     

Efficacy of itraconazole, terbinafine, fluconazole, griseofulvin and ketoconazole in the treatment of Scopulariopsis brevicaulis causing onychomycosis of the toes

BACKGROUND: Scopulariopsis brevicaulis is a common non-dermatophyte mould that can cause onychomycosis. OBJECTIVE: To evaluate the efficacy and safety of the oral antifungal agents griseofulvin, ketoconazole, itraconazole, fluconazole and terbinafine in the treatment of S. brevicaulis. PATIENTS AND METHODS: In a prospective, comparative, parallel-group, single-blinded, randomized, non-industry-sponsored study, patients with toe onychomycosis caused by S. brevicaulis sp. were randomized and treated with one of 5 oral antifungal agents, i.e. griseofulvin, ketoconazole, itraconazole (pulse), fluconazole or terbinafine. The treatment regimens were: griseofulvin 600 mg twice daily for 12 months, ketoconazole 200 mg daily for 4 months, itraconazole pulse therapy given for 3 pulses, with each pulse consisting of 200 mg twice daily for 1 week with 3 weeks off between successive pulses, terbinafine 250 mg daily for 12 weeks and fluconazole 150 mg daily for 12 weeks. RESULTS: There were 59 patients (48 males, 11 females, mean age 35.6 years, range 25-53 years). All patients had clinical evidence of distal and lateral onychomycosis, with moderate to severe disease of the target nail. Between the treatment groups there was no significant difference in the mean age of the patients or the mean area of involvement with onychomycosis at baseline. The efficacy parameters were clinical cure (CC) and mycological cure (MC). At month 12 after the start of treatment, the response was: griseofulvin, CC 3/11, MC 0/11, CC + MC 0/11; ketoconazole, CC 10/12, MC 8/12, CC + MC 8/12; itraconazole, CC 12/12, MC 12/12, CC + MC 12/12; terbinafine, CC 12/12, MC 11/12, CC + MC 11/12, and fluconazole, CC 8/12, MC 8/12, CC + MC 8/12. Adverse effects consisted of: griseofulvin, gastro-intestinal symptoms, allergic reaction, photodermatitis, hepatic and renal dysfunction in 11 patients with discontinuation of treatment in 3 patients; ketoconazole, hepatic dysfunction but no symptomatic changes in 2 patients; itraconazole, nausea and vomiting in 2 patients; terbinafine, taste disturbance in 2 patients, nausea in 3 patients, and fluconazole, severe gastro-intestinal events in 5 patients. None of the patients receiving ketoconazole, itraconazole, terbinafine or fluconazole discontinued treatment. CONCLUSIONS: Itraconazole and terbinafine demonstrate efficacy against some cases of S. brevicaulis toe onychomycosis. These agents also appear to be safe in the course of therapy for toe onychomycosis. Griseofulvin is ineffective against toe onychomycosis caused by S. brevicaulis. Ketoconazole is not recommended for toe onychomycosis given its potential for adverse effects, particularly with the availability of the newer antifungal agents.     

Successful treatment of oral itraconazole for infantile hemangiomas: A case series

Infantile hemangiomas can present a therapeutic challenge to clinicians, especially when associated with severe pain and feeding difficulties. The standard therapeutic management includes corticosteroids and propranolol. However, the clinical response is not always satisfactory. We present six cases of infantile hemangiomas successfully treated with oral itraconazole approximately 5 mg/kg per day. In the first month, the red color of the lesions became a little lighter and the growth of the lesions was controlled in all cases. An obvious clinical improvement was noted in all cases during the 3‐month period, with 80–100% improvement in each patient at the end of the treatment, which was judged by both their parents and the dermatologists. Compliance with treatment instructions of oral itraconazole in infants was judged to be very good. Side‐effects were mild and limited. Although itraconazole can inhibit angiogenesis and tumor growth in vitro and in vivo associated with some cancers, further research is required to understand the pathogenesis of infantile hemangiomas and the mechanism of itraconazole.     

An open-label efficacy pilot study with pimecrolimus cream 1% in adults with facial seborrhoeic dermatitis infected with HIV

BACKGROUND: Seborrhoeic dermatitis (SD) is a common dermatosis in human immunodeficiency virus (HIV)-positive patients, many of whom do not respond satisfactorily to conventional topical treatments such as corticosteroids and antifungals. OBJECTIVE: A pilot study to investigate the efficacy and tolerability of pimecrolimus cream 1% in HIV-positive patients with facial SD. METHODS: In a single-centre study, 21 HIV-infected patients with mild to severe SD were treated twice daily with pimecrolimus cream 1% for 14 days. Thereafter, treatment was discontinued and patients followed up for 5 weeks. Skin involvement at baseline and on days 7, 14, 21, 35 and 49 was assessed using a four-point clinical score and digital photography. MAIN OUTCOME MEASURES: Efficacy and safety of pimecrolimus cream 1% treatment and incidence of relapse in the follow-up phase. Results Marked improvement was seen in clinical parameters at day 7, with >or= 90% patients clear of symptoms at day 14. Relapse was observed at day 35 but signs were milder than at baseline. All patients responded to therapy, despite their immunological status. Pimecrolimus did not alter CD4(+) and CD8(+) T-cell counts or viral load during the treatment period. CONCLUSION: Pimecrolimus cream represents a new, effective therapeutic option for facial SD in HIV patients.     

Itraconazole is effective in the treatment of tinea capitis caused by Microsporum canis

Tinea capitis is a relatively common superficial fungal infection in children which requires oral antifungal therapy. In a prospective, open study over 24 weeks, itraconazole 5 mg/kg/day, given as capsules or as an oral suspension for a period of 2-12 weeks, was used to treat children 1-12 years of age who had M. canis tinea capitis. Children with mycologic evidence of M. canis tinea capitis were entered into the study and asked to return at week 2 and then every 2 weeks thereafter until cured, with a maximum of 12 weeks of active treatment. At each visit the scalp was sampled and the material processed for light microscopy and culture examination. An extra 2 weeks of itraconazole was prescribed if the mycology from the sample obtained on the previous visit indicated that there was still presence of the organism. Patients were administered either 2, 4, 6, 8, 10, or 12 weeks of treatment. The final follow-up visit was at 12 weeks from the cessation of drug therapy. Laboratory blood testing was performed only if indicated by history, examination, or the development of side effects. There were 107 patients (49 boys, 58 girls; mean +/- standard error =5.6 +/- 0.2 years). Thirteen of the 107 children were given the oral suspension. At week 12 from the cessation of treatment there was complete (clinical and mycologic) cure in all 107 children. Increasing age of the patient correlated significantly with the length of itraconazole capsule therapy (p=0.03). The duration of itraconazole treatment also correlated significantly with the severity of tinea capitis at baseline (p=0.02). Adverse effects were observed in 5 children receiving itraconazole capsules (n=94). These were regarded as being possibly or probably due to the drug in two children (mild transient stomach ache in one and moderate diarrhea in one). The child with diarrhea stopped therapy at week 4 with complete resolution of symptoms. One of 13 children receiving the oral suspension had mild, transient diarrhea. There were no drop-outs in this group. Laboratory testing was not required in any patient. Compliance was very good in the patient group. Itraconazole 5 mg/kg/day given either as a capsule or an oral suspension for 4-8 weeks is effective and safe in the treatment of tinea capitis caused by M. canis.     

Oral zinc sulfate in the treatment of rosacea: a double-blind, placebo-controlled study

BACKGROUND: Rosacea is a skin problem not uncommonly encountered world-wide. There is a need for an effective and well-tolerated treatment for this disease. OBJECTIVE: To evaluate the efficacy and side-effects of zinc sulfate in rosacea in a randomized, controlled, double-blind trial. PATIENTS AND METHODS: Patients with rosacea who attended the outpatient Clinic of Dermatology and Venereology in Baghdad Teaching Hospital were recruited into this study between October 2002 and August 2004. A disease severity score was calculated for each patient. The patients were randomly allocated to receive either zinc sulfate 100 mg or identical placebo capsules three times per day. Zinc sulfate and placebo capsules were given in a double-blind manner. Following 3 months of starting the treatment, the patients crossed over, i.e. patients on placebo crossed over to zinc sulfate and those on zinc sulfate crossed over to placebo. RESULTS: Twenty-five patients with rosacea were included in this study: 16 (64%) females and nine (36%) males. Nineteen patients completed the study: 11 (58%) females and eight (42%) males. Patient age ranged from 21 to 64 years with a mean +/- SD of 48.2 +/- 9.3 years. Duration of the disease ranged from 1 to 14 years with a mean +/- SD of 4.4 +/- 3.2 years. In the group started on zinc sulfate, the score before therapy ranged from 5 to 11 with a mean +/- SD of 8 +/- 2.0. The mean started to decrease directly after the first month of therapy with zinc sulfate to a significantly lower level. After shifting to placebo treatment, the mean started to rise gradually in the fifth month but remained significantly lower than the levels before therapy. In the group started on placebo, the score before therapy ranged from 5 to 9 with a mean +/- SD of 7 +/- 1.3. The mean remained high in the first 3 months of therapy while the patients were on placebo. After shifting to zinc sulfate, the mean started to decrease after the fourth month to significantly low levels. No important side-effects were reported apart from mild gastric upset in three (12%) patients on zinc sulfate. CONCLUSION: Zinc sulfate was found to be a good option in the treatment of rosacea, as it was safe, effective and lacking important side-effects.     

A double-blind, randomized study comparing itraconazole pulse therapy with continuous dosing for the treatment of toe–nail onychomycosis

In this multicentre, double–blind, parallel group study, we evaluated the efficacy and safety of continuous treatment with itraconazole, 200 mg daily for 3 months, in comparison with itraconazole pulse therapy, 400 mg daily 1 week per month for 3 months, in the treatment of toe–nail onychomycosis. The study included 129 patients with distal subungual onychomycosis of the toe–nails, confirmed by microscopy and positive for dermatophyte culture; 65 received continuous treatment and 64 received pulse therapy. Patients were followed up for 9 months after treatment. After 12 months, there were 62 evaluable patients in the continuous group and 59 evaluable patients in the pulse group. The clinical response (i.e. the size of the affected area and the progress of the infection) and mycological cure (i.e. negative results on microscopy and culture) were the main outcome measures. A clinical response was defined as a cure or a marked improvement. Clinical response rates were 69%, in the continuous group, and 81% in the pulse group at month 12; the corresponding mycological cure rates were 66 and 69%. A better improvement in signs and symptoms was noted in the pulse group. Six patients were withdrawn from treatment because of adverse events, not all of which were thought to be drug–related. There were no clinically relevant laboratory abnormalities. We conclude that both regimens are effective, safe and well tolerated. The superiority of one treatment over the other was not established, but the results tended to favour pulse therapy. Equivalence testing confirmed that pulse therapy was at least equivalent to continuous treatment.     

Pimecrolimus 1% cream in the treatment of vulvar lichen sclerosus in postmenopausal women

Background Vulvar lichen sclerosus (LS), a poorly recognized chronic inflammatory skin disease, may represent a therapeutic challenge. Pimecrolimus cream 1% is a nonsteroidal, selective inflammatory cytokine inhibitor that has recently been indicated for some inflammatory cutaneous diseases. Objective To investigate the efficacy, tolerability, and safety of 1% pimecrolimus cream therapy in postmenopausal women with LS. Methods A total of 16 patients applied pimecrolimus cream 1% twice a day over the first 3 months and then as required. All the patients completed this study and were then followed up over the next 12 months. The symptoms and clinical appearance of the lesions in every subject were recorded before and after treatment using a severity scale. Results Using pimecrolimus, most of the patients exhibited a significant improvement with respect to symptoms and the clinical appearance of the disease. After 3 months of treatment, complete remission was seen in 11 patients, partial remission in four, whereas one patient experienced no response at all. Over the subsequent 12 months of follow‐up, 10 patients exhibited complete remission while five had partial remission. Four cases with complete remission experienced a few relapses during the follow‐up period. Older patients and those with an advanced stage of the disease responded poorly. No significant side effects were observed. Conclusions Pimecrolimus cream 1% appears to be an effective and well‐tolerated therapeutic alternative option in the treatment of early stage of vulvar LS. Pimecrolimus may reduce the incidence of flare ups, improve long‐term disease control, and enhance the patients’ quality of life, especially in postmenopausal women.