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Efficacy of Itraconazole in the treatment of Seborrheic Dermatitis.

Phase 4
Conditions
Seborrhoeic dermatitis.
L21 Seborrhoeic dermatitis Excl: Seborrhoea capitis
L21.8 Other seborrhoeic dermatitis L21.9 Seborrhoeic dermatitis, unspecified
Registration Number
IRCT2012091510842N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
68
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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