Comparing effect of sertaconazole 2% cream versus clotrimazole 1% cream on treatment of seborrheic dermatitis in adult: Double blind randomized clinical trial
Objectives: To assess the effect of sertaconazole 2% cream versus clotrimazole 1% cream on treatment of seborrheic dermatitis in adult.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients with seborrheic dermatitis who will refer to Sina Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 65 years; seborrheic dermatitis the scalp and face area.
Exclusion criteria: pregnancy or breastfeeding; severe seborrheic dermatitis with Itching score greater than 7; treatment with local or systemic corticosteroid, methyldopa, chlorpromazine, or anti-acne drugs during the last month; systemic disease such as Parkinson, AIDS, and mood disorder; sensitivity to drug.
Intervention group 1: Sertaconazole 2% cream twice a day for 4 weeks.
Intervention group 2: Clotrimazole 1% cream twice a day for 4 weeks.
Primary outcome: Number and size of the wound before and 4 weeks after intervention through clinical examination.
Randomization The patients will be randomly assigned to the intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701299014N141
Registration date:2017-01-29, 1395/11/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-29, 1395/11/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of sertaconazole 2% cream versus clotrimazole 1% cream on treatment of seborrheic dermatitis in adult: Double blind randomized clinical trial
Public title
Comparing effect of sertaconazole 2% cream versus clotrimazole 1% cream on treatment of seborrheic dermatitis in adult
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 65 years; seborrheic dermatitis the scalp and face area.
Exclusion criteria: pregnancy or breastfeeding; severe seborrheic dermatitis with Itching score greater than 7; treatment with local or systemic corticosteroid, methyldopa, chlorpromazine, or anti-acne drugs during the last month; systemic disease such as Parkinson, AIDS, and mood disorder; sensitivity to drug.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization The patients will be randomly assigned to the intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.473
Health conditions studied
1
Description of health condition studied
Seborrheic dermatitis
ICD-10 code
L21.9
ICD-10 code description
Seborrhoeic dermatitis, unspecified
Primary outcomes
1
Description
Number and size of the wound
Timepoint
before and 4 weeks after intervention
Method of measurement
through clinical examination.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Sertaconazole 2% cream twice a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Clotrimazole 1% cream twice a day for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Ali Abbas Shabak
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Sina Hospital
Full name of responsible person
Dr Ali Abbas Shabak
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
alishabak8@gmail.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr Akram Ansar
Position
Dermatologist
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
akram.ansar@yhoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)