ORAL ITRACONAZOLE FOR THE TREATMENT OF SEVERE SEBORRHOEIC

DERMATITIS
Jayasri Das, Monalisa Majumdar,1 Urmita Chakraborty,1 Vivek Majumdar, Gautam
Mazumdar, andJayasree Nath
Abstract
Background : Seborrheic dermatitis (SD) is an inflammatory skin disorder in which colonies
ofMalassezia 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.
Keywords: Seborrheic dermatitis, itraconazole, pityriosporum, intermittent therapy

Introduction
Seborrheic dermatitis (SD) is a common chronic erythematous scaly eruption usually
seen in areas rich in sebaceous glands. Two main factors are the presence of a generous
amount of epidermal lipids and colonization by Malassezia species (lipophilic, usually non
pathogenic yeast forms, a part of normal human cutaneous flora; however, under the
influence of certain predisposing factors, they become pathogenic). Clinical features show
varied morphology. Erythematous reddish yellow, poorly circumscribed patches with fine
scale, which are mildly pruritic, are seen. Common sites are scalp (dandruff), eye brows,
perinasal areas, ears, retroauricular areas, neck, and anterior and posterior trunk (annular or
petaloid forms are seen).
There are several topical and systemic therapies. Itraconazole is a highly
keratinophilic and lipophilic triazole. Secretion in sebum is a major route by which the drug
reaches the stratum corneum. The aim of the study was to determine the efficacy and safety
of oral itraconazole capsule 100 mg given twice daily for 7 days and consecutive usage in the
treatment of the severe SD.

Materials and Methods

The study was an open noncomparative clinical trial in which 30 patients were
evaluated. Written consent was obtained from each patient before entering the study. The
patients were clinically evaluated according to the following items: Itching, burning

erythema, scaling, and seborrhea. This study was carried out in the winter and early spring
seasons, in which SD is normally exacerbated. The clinical efficacy parameter was the
proportion of patients who achieved complete or nearly complete disappearance of clinical
features. Patients who had used systemic antibiotics, systemic antifungals, topical steroids,
topical antifungals, selenium sulfide or zinc pyrithione within 15 days prior to the study were
excluded. The patients included belonged to the age group of 18 years or above. In all the
patients, complete blood count, liver function test (LFT), serum urea, serum creatinine, and
mycological examination were done before starting the therapy. In the treatment protocol,
itraconazole capsule 100 mg twice a day was given for 1 week; then after a 3-week interval
100 mg capsule was given twice a day for 2 days of following months for two consecutive
months. The evaluation of results was performed on day 15, day 30, day 60, and day 90. The
clinical response was graded as markedly effective, effective, or ineffective. The mycological
examination was done after treatment to evaluate further.

Results
Thirty patients were enrolled in the study. Out of these 30 patients, 21 were male and
9 were female. In all of these patients, response to conventional therapy was very
unsatisfactory. The evaluation of clinical improvement showed at the end of 90 days was that
a markedly effective result was seen in 18 patients (60%). A moderate response was seen in 7
patients (23.3%) and in 5 patients (16.6%) no improvement was seen. None of the patients
showed any adverse effect with itraconazole [Figure 1].

Figure 1
Percentage of the response of itraconazole therapy in seborrhoeic dermatitis

Discussion
SD is an inflammatory disorder of the skin characterized by erythema and scaling
over the areas rich in sebaceous glands, the scalp, face, chest, back, and flexural areas. The
enigma of SD is yet unsolved.[1] Probably the organism Pityrosporum ovale, Pityrosporum
lipase activity, skin surface lipids, and lastly immune dysfunction may play a role. It has been
suggested that SD is an inflammatory response to these organisms.[2] Malassezia
restricta/globosa, which plays an important role in the pathogenesis of SD,[3] stimulates
cytokine production by keratinocytes. Many studies showed that antimycotics are effective in
clearing lesions with a reduction in the number of Malassezia yeasts.
The efficacy of azole and imidazole antimycotics may be due to their antiinflammatory action. They inhibit the cell wall lipid synthesis of the organisms (antifungal
activity of the azoles is via inhibition of lanosterol 14 demethylase) and may have some
effects on the skin surface lipids.[4] Itraconazole is anti-inflammatory primarily because of its
inhibitory effect on the synthesis of 5-hypoxygenase metabolites, which are involved in
several inflammatory diseases such as SD. In one study, Mastaro treated 30 patients with SD
of head and face, who used 150 or 200 mg once per week for 2-3 months. A total of 67% of
patients showed marked improvement.[5] Faergemann evaluated 10 patients with
sebopsoriasis of the scalp and face. Patients were started on itraconazole 50 mg per day for 2
weeks. If this dosage was well tolerated, the dose was increased to 100 mg per day for
another 4 weeks. Five patients were cured.[6]
In our study, patients were given itraconazole 200 mg per day for 7 days and then 200
mg per day for 2 days in the following 2 months. By the end of 90 days, the treatment was
found to be markedly effective in 60% cases, moderately effective in 23.3%, and no
improvement was noticed in 16.6%. The use of oral itraconazole capsule clearly diminished
the symptoms (especially erythema and desquamation) of the disease. Patients also noticed
the reduction of burning and itching sensation.
The anti-inflammatory activity of oral itraconazole and its efficacy
on Malassezia yeast suggest that itraconazole may be one of the safe and effective treatments
of SD although it is evident that future research is needed about the efficacy and safety of this
drug in a comparative or placebo-controlled clinical trial.[3]

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