Effect of topical treatments of psoriasis with ointment Fluocinolon 0.125% and lotion Betamethasone 0.05% on the level of IL-17 in patients with psoriasis: a before-after clinical trial
Objectives: To assess the effect topical treatments of psoriasis with ointment Fluocinolon 0.125% and lotion Betamethasone 0.05% on the level of IL-17 in patients with psoriasis.
Design: A before-after clinical trial.
Setting and conduct: The eligible patients with psoriasis who will refer to farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Having psoriatic lesions.
Exclusion criteria: (a) pregnancy or breastfeeding; (b) using local or systemic corticosteroid during the past 3 months; (c) history of autoimmune or inflammatory disease.
Intervention group: Ointment Fluocinolon 0.125% for lesions of trunk and limbs and lotion Betamethasone 0.05% for scalp lesions very night for one month.
Control group: there is no comparison group. The intervention group will be compared before and after intervention.
Primary outcome: Measuring the level of IL-17 before treatment and 4 weeks after treatment using laboratory test.
Secondary outcome: Nothing.
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606289014N104
Registration date:2016-07-05, 1395/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-05, 1395/04/15
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 the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2017-05-15, 1396/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical treatments of psoriasis with ointment Fluocinolon 0.125% and lotion Betamethasone 0.05% on the level of IL-17 in patients with psoriasis: a before-after clinical trial
Public title
Effect of topical treatments of psoriasis with ointment Fluocinolon 0.125% and lotion Betamethasone 0.05% on the level of IL-17 in patients with psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having psoriatic lesions.
Exclusion criteria: (a) pregnancy or breastfeeding; (b) using local or systemic corticosteroid during the past 3 months; (c) history of autoimmune or inflammatory disease.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
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
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.62
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Measuring the level of IL-17
Timepoint
before treatment and 4 weeks after treatment
Method of measurement
using laboratory test
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Ointment Fluocinolon 0.125% for lesions of trunk and limbs and lotion Betamethasone 0.05% for scalp lesions very night for one month
Category
Treatment - Drugs
2
Description
there is no comparison group. The intervention group will be compared before and after intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Fariba Shadfar
Street address
Farshchian 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
Farshchian Hospital
Full name of responsible person
Dr Fariba Shadfar
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+81 38274184
Fax
Email
faribashadfar03@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mohammad Reza Sobhan
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
mreza_sobhan@yahoo.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)