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The comparision study of sertaconazole 2% cream versus pimecrolimus 1% cream in the treatment of facial seborrheic dermatitis

Protocol summary

Summary
The aim of this study is to compare the efficacy of two non steroidal creams, sertaconazole cream 2% with pimecrolimus cream 1%, in the treatment of seborrheic dermatitis. Adulthood patients with face seborrhoeic dermatitis (frontal hair line, eyebrows, forehead gellabella area, nasolabial folds and or anterior auricular regions) with no systemic disease will enroll. The cases are the patients who will visit by a dermatologist in clinics or offices of Semnan city of Iran. The diagnosis of disease will be clinically. Sixty patients with seborrhoeic dermatitis are selected and will be divided randomly into two equal groups. This study will take six months. The patients will apply one of two drugs, twice a day for four weeks. The patients will be visited by a dermatologist (blind to type of drug) in 0, 2, 4, 8 weeks of starting treatment and will get a special score in each visit. The scoring will be base on the severity of erythema, scaling, itching , and burning sensation of damage area, which are rated from 0-3 ( 0 = absent , 1 = mild , 2 = moderate , 3 = severe ). The sum of these values shows the severity of disease (0-4= mild, 5-8= moderate, 9-12=severe) Moreover, patient’s satisfaction will be asked and recorded at the end of weeks 2 and 4 of treatment as below: No, weak, medium or good improvement. The score of 8 weeks of starting treatment will show the probable relapse.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041613853N1
Registration date: 2014-04-16, 1393/01/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-16, 1393/01/27
Registrant information
Name
Maryam Azizzadeh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 231 3345
Email address
maryamazizzadeh@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Semnan University of Medical Science
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision study of sertaconazole 2% cream versus pimecrolimus 1% cream in the treatment of facial seborrheic dermatitis
Public title
The comparision of sertaconazole versus pimecrolimus in the treatment of facial seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: facial seborrheic dermatitis; any systemic disease. exclusion criteria: taking drugs such as methyldopa, chlorpromazine, cimetidine; use of local and systemic anti-acne ,steroid and immune modulators drugs one month before; lactation and pregnancy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan university of medical science
Street address
Basij Blvd.
City
Semnan
Postal code
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
10900-16-92

Health conditions studied

1

Description of health condition studied
Seborrheic dermatitis (SD)
ICD-10 code
L21
ICD-10 code description
Seborrhoeic dermatitis

Primary outcomes

1

Description
improvment
Timepoint
2 and 4 weeksafter starting treatment
Method of measurement
dermatologist examination

2

Description
exacerbation
Timepoint
1 month after stoping treatment
Method of measurement
dermatologist examination

3

Description
treatment duration
Timepoint
4 weeks
Method of measurement
time

4

Description
patient satisfaction
Timepoint
2 and 4 weeks after starting treatment
Method of measurement
question of patient

Secondary outcomes

1

Description
side effect
Timepoint
2 and 4 weeks after starting treatment
Method of measurement
dermatologist examination

Intervention groups

1

Description
Topical pimecrolimus cream 1% will be given to the 30 patients. They will be recommended to use tip finger amount of cream to each involved area, 2 times daily for 4 weeks. The Patients will be visited by a dermatologist (who is blind to the type of drug) on zero, 2, 4 and 8 weeks of starting treatment, in order to evaluate the clinical symptoms and complications.
Category
Treatment - Drugs

2

Description
Topical sertaconazole cream 2% will be given to the 30 patients. They will be recommended to use tip finger amount of cream to each involved area, 2 times daily for 4 weeks. The Patients will be visited by a dermatologist (who is blind to the type of drug) on zero, 2, 4 and 8 weeks of starting treatment, in order to evaluate the clinical symptoms and complications.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic
Full name of responsible person
Dr. Maryam Azizzadeh
Street address
17 e shahrivar blvd.
City
Semnan

2

Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Dr. Maryam Azizzadeh
Street address
Basij Blvd.
City
Semnan

3

Recruitment center
Name of recruitment center
Dermatology office
Full name of responsible person
Dr. Maryam Azizzadeh
Street address
No.2, Third floor, Sadaf building, Saadi square
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research -Semnan University of Medical Science
Full name of responsible person
Dr. mohammadreza Askari
Street address
Basij Blvd.
City
Semnan
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 -Semnan University of Medical Science
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
Semnan University of Medical Science
Full name of responsible person
Maryam Azizzadeh
Position
Dermatologist
Other areas of specialty/work
Street address
Kowsar hospital- Basij Blvd.
City
Semnan
Postal code
Phone
+98 23 1333 7856
Fax
Email
maryamazizzadeh@semums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Maryam Azizzadeh
Position
Dermatologist
Other areas of specialty/work
Street address
Kowsar hospital- Basij Blvd.
City
Semnan
Postal code
Phone
+98 23 1333 7856
Fax
Email
maryamazizzadeh@semums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Maryam Azizzadeh
Position
Dermatologist
Other areas of specialty/work
Street address
Kowsar hospital, Basij Blvd.
City
Semnan
Postal code
Phone
+98 23 1443 7836
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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