Comparison of efficacy and safety of oral itraconazole with placebo in the primary treatment and maintenance therapy of moderate to severe seborrheic dermatitis.
The objective of the study is to compare the efficacy of oral itraconazole with placebo in primary and maintenance treatment of moderate to severe seborrheic dermatitis. Inclusion criteria of the study is: Moderate to severe seborrheic dermatitis that will be diagnosed clinically by a dermatologist+/- Recurrent seborrheic dermatitis+/-Seborrheic dermatitis resistant to Topical therapy; no association of seborrheic dermatitis with other papulosquamous dermatoses, Parkinson disease, AIDS, severe renal or liver disease; Age ≥18. Patients refer to Razi Hospital diagnosed with seborrheic dermatitis who fulfill the criteria will be assigned codes by the study monitor and patients will be randomly allocated either to receive itraconazole or placebo. Blinding will be maintained until patients completed their last follow up visit. The treatment was administered in two different phases. In the first phase, oral Itraconazole 200mg/day or oral placebo along with topical 1% hydrocortisone ointment once daily and 2% ketoconazole cream twice daily for one week will be used by patients. In the second phase which is maintenance period, oral itraconazole 200mg/day or oral placebo will be given on the first 2 days of every month for 4 months. To determine the sample size, if we consider error as 5% and power of study as 90% and mean difference of improvement in two groups as 2, we require 30 patients for this study. By considering 10% lost to follow up in the study, sample size will be increased to 34 patients in each group. As patients can exit the study as they wish and the study has serial long term follow ups, we may have lost to follow ups more than our expectations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091510842N1
Registration date:2013-02-18, 1391/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Zaheer Abbas
Name of organization / entity
Razi Hospital,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21556099523
Email address
abbas_z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-05, 1391/11/17
Expected recruitment end date
2014-05-15, 1393/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of oral itraconazole with placebo in the primary treatment and maintenance therapy of moderate to severe seborrheic dermatitis.
Public title
Efficacy of Itraconazole in the treatment of Seborrheic Dermatitis.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
University central office, 6th floor, Keshavarz Blvd, Qods Ave, Tehran, Iran.
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
2
Description
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 outcomes
1
Description
Disease duration
Timepoint
At beginning of study
Method of measurement
History
2
Description
Dermatology Life Quality Index
Timepoint
At beginning of study and at the end of study(after 6 month)
Method of measurement
Questionnaire
3
Description
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)
4
Description
Site of involvement
Timepoint
At beginning of study
Method of measurement
Physical examination
5
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital, Tehran University of Medical Sciences