Seborrhoeic dermatitis. L21 Seborrhoeic dermatitis Excl: Seborrhoea capitis
Conditions
Interventions
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% ketoconazo
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
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
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZaheer Abbas
Tehran University of Medical Sciences
Outcome results
None listed