This study is a randomized, placebo-controlled, double-blind trial in 70 patients with dermatitis aged 18 years to 65 years with poor response to conventional treatment (topical steroids) at dermatology clinic of Sina hospital in Hamadan. After confirmation of dermatitis by dermatologist and the same drug prescription, all patients will be randomly allocated into two groups according to Random number tables. Intervention group will receive topical atorvastatin 5% two times a day for 10 days with topical betamethason and control group will receive topical betamethason without atorvastatin. Severity of clinical symptoms and pruritus determine by Hand eczema index at baseline, 5 days and 10 days after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070922965N10
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
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-19, 1396/05/28
Expected recruitment end date
2018-08-19, 1397/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of topical Atorvastatin as adjuvant therapy in treatment of hand eczema
Public title
Effect of topical Atorvastatin on hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18-65 years old; Moderate to severe eczema; Patients who less than 25% of their skin is involved; Discountinue of glucocorticoid agents 4 weeks prior to the investigation; Discountinue of antipuritis agents 1 week prior to the investigation
Exclusion criteria: Age less than 18 years old; Patients with inflammatory skin disease; Pregnant woman
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
Used
Assignment
Parallel
Other design features
Neither the participants or the experimenters know who is receiving a particular treatment
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
2017-06-24, 1396/04/03
Ethics committee reference number
IR.UMSHA.REC.1396.290
Health conditions studied
1
Description of health condition studied
Dermatitis
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
Eczema
Timepoint
5 and 10 days following of treatment
Method of measurement
Hand eczema index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Betamethason ointment plus atorvastatin 5% cream 2 times per day for 10 days
Category
Treatment - Drugs
2
Description
Control group: Betamethason ointment plus placebo atorvastatin 5% cream 2 times per day for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina 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
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamedan
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, Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 1594
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
Hamedan University of Medical Sciences, Shahid Fahmide avenue, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 1594
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy, Hamedan University of Medical Sciences
Full name of responsible person
Fateme Ghaedamini
Position
Student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)