Our aim in this study is to compare the effects of Daivonex cream alone or together with narrow-band ultra violet B on treatment of psoriasis. In a randomized clinical trial, 94 patients from both genders with mild psoriasis and referring to dermatology ward of Sina Hospital, Tabriz, Iran, will be randomly treated with Daivonex cream alone or Daivonex together with narrow-band ultraviolet B. Main inclusion criteria are; to have psoriasis with involved body surface area less than 10% and not to have another systemic disease. Main exclusion criteria are pregnancy and lactating. In Daivonex group patients will be asked to apply 0.5 mg of the cream on a palm-sized surface of the body twice a day and in Daivonex plus ultraviolet group patients will be treated using a phototherapy device, Dermapal 800 Davlin, USA, for 33 seconds twice a week with primary energy of 0.2 Joules per square centimeter; plus, patients in the later group will be similarly treated with Daivonex and in the phototherapy days cream will be applied after phototherapy. All the individuals will be examined and compared for recovery in terms of erythema, scaling and lesion thickness before the treatment and 4, 8 and 12 weeks after the initiation of the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903294207N1
Registration date:2013-11-07, 1392/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-07, 1392/08/16
Registrant information
Name
Shahla Babainejad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4652
Email address
babaiesh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-06, 1392/02/16
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effects of Daivonex cream alone or together with narrowband ultra violet B on treatment of psoriasis
Public title
Effects of Vit D3 and ultraviolet on the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to have psoriasis with involved body surface area less than 10%; not to have photo-sensitivity; not to have another systemic disease; and not to have skin malignancies)
Exclusion criteria: (pregnancy and lactating; having a positive drug history within the last month)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
9245
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Erythema
Timepoint
Before the initiation of the treatment and 4, 8 and 12 weeks after the initiation of the treatment.
Method of measurement
By physical examination
2
Description
Scaling
Timepoint
Before the initiation of the treatment and 4, 8 and 12 weeks after the initiation of the treatment.
Method of measurement
By physical examination
3
Description
Lesion thickness
Timepoint
Before the initiation of the treatment and 4, 8 and 12 weeks after the initiation of the treatment.
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
In Daivonex group patients will be asked to apply 0.5 mg of the cream on a palm-sized surface of the body twice a day for three months.
Category
Treatment - Drugs
2
Description
In Daivonex plus ultraviolet group patients will be treated using a phototherapy device, Dermapal 800 Davlin, USA, for 33 seconds twice a week with primary energy of 0.2 Joules per square centimeter for three months; plus, patients in the later group will be similarly treated with Daivonex and in the phototherapy days cream will be applied after phototherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Abolfazl Ezzati
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, 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
Abolfazl Ezzati
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 1541 2151
Fax
Email
abo.ezzati@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
Shahla Babainejad
Position
Dermatologist/Associate professor
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 1541 2151
Fax
Email
drshbabaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
Emam Reza Hospital, Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)