Comparative Effectiveness of Atorvastatin 5% lotion vs betamethasone lotion in treatment of seborrheic dermatitis in adult: Double blind Randomized Clinical trial study
This study is a randomized,Without using a placebo-controlled,double-bind trial in 70 patients with seborrheic dermatitis aged 18 years to 65 years at dermatology clinic of hospital in Hamadan.After confirmation of seborrheic dermatitis by dermatologist and the same drug prescription,all patients will be randomly allocated into two groups according to randomly number tables.In one group, receive 5% of atorvastatin lotion daily with ketoconazole shampoo 3 times a week for 4 weeks, and the other group receive betamethasone lotion 3 times a week with ketoconazole shampoo 3 times a week.Severity of clinical symptoms are determined in all patients using the recommended Koca scoring system at the earliest stages of treatment, 2 weeks, 4 weeks, and 4 weeks after the end of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070922965N11
Registration date:2017-07-18, 1396/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-18, 1396/04/27
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Ethics Committee of Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Atorvastatin 5% lotion vs betamethasone lotion in treatment of seborrheic dermatitis in adult: Double blind Randomized Clinical trial study
Public title
Effect of topical atorvastatin in seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Patients with seborrheic dermatitis in the scalp and face with clinical diagnosis؛Lack of treatment with topical or systemic corticosteroids،Methyl dopa، Chlorpromazine،Topical or systemic acne medications from a month before referral؛Failure to develop a systemic disorder, such as Parkinson's disease, AIDS, mood disorders.
exclusion criteria:Report any allergy to the drug, such as Contact dermatitis؛Dissatisfaction with drug use and collaborative study؛Lack of referral for follow up and observation of the therapeutic efficacy of the drug؛Having a very severe type of disease(Itching score greater than 7)؛Pregnancy and lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Khajerashid,Ayatollah Kashani,Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.310
Health conditions studied
1
Description of health condition studied
seborrheic dermatitis
ICD-10 code
L21.8
ICD-10 code description
Other seborrhoeic dermatitis
Primary outcomes
1
Description
seborrheic dermatitis
Timepoint
2 and 4 weeks following of treatment and4 weeks after the end of treatment.
Method of measurement
Koca scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ketoconazole shampoo three times a week with 5% atorvastatin lotion daily
Category
Treatment - Drugs
2
Description
Control group: ketoconazole shampoo 3 times a week with betamethasone lotion daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research,Hamadan University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Hamadan University of Medical Sciences ,Shahid Fahmide avenue ,Hamadan
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,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
School of Pharmacy,Hamadan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences,Shahid Fahmide avenue,Hamadan
City
Hamadan
Postal code
Phone
+98 81383811594
Fax
Email
m-mehrpooya2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences,Shahid Fahmide avenue,Hamadan
City
Hamadan
Postal code
Phone
+98 81383811594
Fax
Email
m-mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Full name of responsible person
Ghazal Gholampour
Position
student
Other areas of specialty/work
Street address
City
Hamadan
Postal code
Phone
+98 81383811594
Fax
Email
gholampoorg@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)