Aim:To study the efficacy oral fluconazole compared to oral terbinafine in the treatment of moderate to severe seborrheic dermatitis.
Inclusion criteria: Patients with moderate to severe seborrheic dermatitis¸ filling the consent form,no previous treatment history at least 2 weeks before entering the study such as steroids, antifungal. Exclusion criteria:Lactation ¸ pregnancy ¸ no pervious diseases such as renal and liver failure, psoriasis, documented human immunodeficiency virus infection and/or sensitivity to fluconazole and terbinafine.
Patients with random allocation were divided into two groups of A and B. In group A 32 patients received fluconazole 300 mg per week for 4 weeks and in group B, we prescribed 32 patients terbinafine 250 mg per day. In the beginning ¸ the seborrheic dermatitis area severity index (SDASI) scoring were calculated and the symptoms were assessed.
At first and two and four weeks after treatment tests including CBC, BUN, Cr, AST, ALT, ALK- Ph were requested to monitor drug side effects. After 4 weeks of treatment and two-week posttreatment, all patients are re-examined and evaluated again through SDASI scoring and also symptoms were asked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102205871N1
Registration date:2013-02-05, 1391/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-05, 1391/11/17
Registrant information
Name
Narges Alizadeh
Name of organization / entity
Gilan university of medical scenes
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 0169
Email address
n_alizadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gilan University Medical of Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral fluconazole and oral Terbinafine in the treatment of moderate to severe seborrheic dermatitis
Public title
Comparison of the efficacy of oral fluconazole and oral Terbinafine in the treatment of moderate to severe seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with moderate to severe seborrheic dermatitis¸ filling the consent form,no previous treatment history at least 2 weeks before entering the study such as steroids, antifungal agents.
Exclusion criteria:Lactation ¸ pregnancy ¸ no pervious diseases such as renal and liver failure, psoriasis, documented human immunodeficiency virus infection and/or sensitivity to fluconazole and terbinafine
Age
From 15 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gilan University of Medical Sciences
Street address
Moavenat Pazhooheshi -Namjo avenue
City
Rasht
Postal code
Approval date
2009-08-26, 1388/06/04
Ethics committee reference number
1880409102
Health conditions studied
1
Description of health condition studied
Seborrhoeic dermatitis
ICD-10 code
L21
ICD-10 code description
Seborrhoeic dermatitis
Primary outcomes
1
Description
SDASI (Seborrheic dermatitis area severity index)
Timepoint
weeks 4 , 6
Method of measurement
Determine severity of disease by examiner according to SDASI
2
Description
itch
Timepoint
4 weeks later and 6 weeks later
Method of measurement
subjective
Secondary outcomes
1
Description
Side effects
Timepoint
at first,two and four weeks after treatment
Method of measurement
history,physical exam, laboratory tests
Intervention groups
1
Description
Fluconazole 300 mg weekly for four weeks
Category
Treatment - Drugs
2
Description
Terbinafine 250 mg daily for four weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Razi hospital
Full name of responsible person
Dr Hamed Monadi Nori
Street address
Razi hospital-Sardarjangal avenue-Entezam square
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gilan University of Medical Sciences
Full name of responsible person
Jalali mir mohammad
Street address
Gilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gilan University of Medical Sciencse
Full name of responsible person
Hamed Monadi Nori MD
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Razi hospital -Sardarjangal avenue
City
Rasht
Postal code
Phone
+98 13 1554 1001
Fax
+98 13 1553 0169
Email
hamedmonadinori@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gilan University of Medical Sciences
Full name of responsible person
Narges Alizadeh MD
Position
Assistant professor
Other areas of specialty/work
Street address
Razi hospital- Sarderjangal avenue
City
Rasht
Postal code
Phone
+98 13 1554 1001
Fax
Email
n_alizadeh@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gilan University of Medical Sciences
Full name of responsible person
Hamed Monadi Nori MD
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Razi hospital-Sardarjangal avenue
City
Rasht
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)