Objectives: To compare the efficacy of sertaconazole 2% cream versus hydrocortisone 1% cream in the treatment of seborrheic dermatitis
Design: Clinical trial study
Setting and conduct: Randomized clinical trial study
Participants including major eligibility criteria: Sixty patients with seborrheic dermatitis (SD) were studied
Intervention: Thirty patients received topical sertaconazole 2% cream and were recommended to use the cream twice a day for 4 weeks. In the control group, 30 patients received hydrocortisone 1% cream and were recommended to use the cream twice a day for 4 weeks.
Main outcome measures: At the start of the study and also 2 and 4 weeks after first visit, the patients were examined by a dermatologist for signs of improvement and control of clinical symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310185605N2
Registration date:2014-01-16, 1392/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-16, 1392/10/26
Registrant information
Name
MOHAMAD GOLDUST
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133614711
Email address
medres@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-08-23, 1391/06/02
Expected recruitment end date
2013-02-20, 1391/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sertaconazole 2% cream versus hydrocortisone 1% cream in the treatment of seborrheic dermatitis
Public title
Sertaconazole 2% cream versus hydrocortisone 1% cream in the treatment of seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Sixty patients with seborrheic dermatitis (SD) were studied.
Patients who had taken oral corticosteroids; retinoids; antihistamines; or immune-modulating drugs within 28 days before study entery were excluded.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethic committee of Tabriz university of medical sciences
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
9098
Health conditions studied
1
Description of health condition studied
Seborrheic dermatitis
ICD-10 code
L21
ICD-10 code description
Seborrheic dermatitis
Primary outcomes
1
Description
Seborrheic index
Timepoint
2 weeks
Method of measurement
Clinical assesment
Secondary outcomes
empty
Intervention groups
1
Description
In the case group thirty patients received topical sertaconazole 2% cream and were recommended to use the cream twice a day for 4 weeks.
Category
Treatment - Drugs
2
Description
In the control group, 30 patients received hydrocortisone 1% cream and were recommended to use the cream twice a day for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of dermatology, Sina hospital
Full name of responsible person
Dr Mehdi Amirnia
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Ali Meshkini
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Mohamad Goldust Jouybari
Position
Medical student
Other areas of specialty/work
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Drmgoldust@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Mohammad Reza Ranjkesh
Position
Assistant professor in dermatology
Other areas of specialty/work
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Mranjkesh@Razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)