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IRCT2012091510842N1 IRCT 2013-02-18 Tehran University of Medical Sciences Efficacy of Itraconazole in the treatment of Seborrheic Dermatitis. Comparison of efficacy and safety of oral itraconazole with placebo in the primary treatment and maintenance therapy of moderate to severe seborrheic dermatitis. 2013-02-05 anticipated 68 Complete https://irct.ir/trial/11270 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 4 Seborrhoeic dermatitis. Intervention 1: The treatment will be administered in two different phases. In the first phase, oral Itraconazole 200mg/day along with topical 1% hydrocortisone ointment once daily and 2% ketoconazole cream twice daily for one week will be used by patients. Patients will be advised to apply topical therapy to scalp, face and areas involved. In the second phase which is maintenance period, oral itraconazole 200mg/day will be given on the first 2 days of every month for 4 months. Intervention 2: In the control group, in the first phase, placebo capsule 200mg/day along with topical 1% hydrocortisone ointment once daily and 2% ketoconazole cream twice daily for one week will be used by patients. Patients will be advised to apply topical therapy to scalp, face and areas involved. In the second phase which is maintenance period, oral placebo 200mg/day will be given on the first 2 days of every month for 4 months.
public Zaheer Abbas
Razi Hospital, Vahdate Eslami Ave, Vahdate Eslami square, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21556099523 drzaheerabbas@yahoo.com Tehran University of Medical Sciences scientific Zaheer Abbas
Razi Hospital, Vahdate Eslami Ave, Vahdate Eslami square, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21556099523 drzaheerabbas@yahoo.com Razi hospital, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Moderate to severe seborrheic dermatitis that will be diagnosed clinically by a dermatologist +/- Recurrent seborrheic dermatitis +/- Seborrheic dermatitis resistant to Topical therapy; Age ≥18; Patients willing to take part in the study and expected to be available for the duration of study and comply with study visits. Exclusion criteria: Seborrheic Dermatitis(SD) associated with any other papulosquamous dermatoses like psoriasis, rosacea, lupus erythematous, lichen planus, tinea, and eczema; Significant renal or liver disease; AIDS; Parkinson Disease; Allergy to azoles; Drug use interfering with itraconazole; Very severe dermatitis defined by erythrodermia or extensive flexural involvement; Use of topical therapy (except moisturizers) and systemic therapy in last 2 week and 1 month, respectively; Pregnancy and lactation. 18 years 70 years Both L21 L21 Seborrhoeic dermatitis Excl: Seborrhoea capitis; L21.8 Other seborrhoeic dermatitis L21.9 Seborrhoeic dermatitis, unspecified Treatment - Drugs Placebo The treatment will be administered in two different phases. In the first phase, oral Itraconazole 200mg/day along with topical 1% hydrocortisone ointment once daily and 2% ketoconazole cream twice daily for one week will be used by patients. Patients will be advised to apply topical therapy to scalp, face and areas involved. In the second phase which is maintenance period, oral itraconazole 200mg/day will be given on the first 2 days of every month for 4 months. In the control group, in the first phase, placebo capsule 200mg/day along with topical 1% hydrocortisone ointment once daily and 2% ketoconazole cream twice daily for one week will be used by patients. Patients will be advised to apply topical therapy to scalp, face and areas involved. In the second phase which is maintenance period, oral placebo 200mg/day will be given on the first 2 days of every month for 4 months. Signs of disease (Scales and erythema). Timepoint: At beginning of study, 2 week later, after 1 month, after 2 month, after 3 month and after 4 month. Method of measurement: Physical examination performed by dermatologist. Symptoms (Pruritis and burning) severity. Timepoint: At beginning of study, 2 week later, after 1 month, after 2 month, after 3 month and after 4 month. Method of measurement: Patient history (Questionnaire). Disease duration. Timepoint: At beginning of study. Method of measurement: History. Dermatology Life Quality Index. Timepoint: At beginning of study and at the end of study(after 6 month). Method of measurement: Questionnaire. Seborrheic Dermatitis Area Severity Index. Timepoint: At beginning of study, 2 week later, after 1 month, after 2 month, after 3 month, after 4 month and after 6 month. Method of measurement: (Erythema+Scales)× Local area score× Constant of that area(calculated in Questionnaire). Site of involvement. Timepoint: At beginning of study. Method of measurement: Physical examination. Side effects of drug. Timepoint: At beginning of study, 2 week later, after 1 month, after 2 month, after 3 month, after 4 month. Method of measurement: History and lab tests. Tehran University of Medical Sciences Approved 2012-09-09 Ethics committee of Tehran University of Medical Sciences University central office, 6th floor, Keshavarz Blvd, Qods Ave, Tehran, Iran. Tehran Iran (Islamic Republic of)