To compare the efficacy of blue light and topical steroid in treatment of plaque psoriasis lesions
Design
This is a double-blind, second phase clinical trial with a non-randomized design. The study incorporates 20 patients with inclusion criteria who refer to the Clinic of Dermatology in the Mashhad-based Ghaem Hospital and Imam Reza Hospital from April 2018 to April 2019. Cutaneous lesions of the patients will be assigned into two groups of light blue or topical steroids without randomization.
Settings and conduct
The study is non-blinded and will be performed in the dermatology clinics of Gham and Imam Reza hospitals in Mashhad.
Participants/Inclusion and exclusion criteria
Main inclusion criteria comprise of patients suffering from limited psoriatic plaque with at least two bilateral localized plaques and a maximum size of four centimeters; intent to participate; not receiving topical psoriasis medications from at least a month ago and systemic therapy or phototherapy from two months ago; and location of lesions on extremities or trunk.
Major exclusion criteria involve history of consuming photosensitizing medications and arthropathic psoriasis.
Intervention groups
In the intervention group, the lesions will be treated by light emitted from Lightcure device for 15 minutes per session 3 times weekly for 4 consecutive weeks. In the control group, lesions will be treated by a moderate topical steroid (fluocinnolone ointment 0.1 percent) every eight hours for 4 consecutive weeks.
Main outcome variables
The main outcomes include the Localized Psoriasis Severity Index and therapy complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N42
Registration date:2018-04-27, 1397/02/07
Registration timing:registered_while_recruiting
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of blue light versus topical steroid in treatment of plaque psoriasis lesions: A randomized clinical trial
Public title
Effects of blue light and topical steroid on plaque psoriasis lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 18 to 80 years
Patients suffering from limited psoriatic plaque with at least two bilateral localized plaques and a maximum size of four centimeters
Not receiving topical psoriasis medications from at least a month ago and systemic therapy or phototherapy from two months ago
Informed written consent to participate in the study
The location of lesions on extremities or trunk
Exclusion criteria:
history of photodermatosis
history of porphyrias
History of consuming photosensitizing medications
Arthropathic psoriasis
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Cutaneous lesions in the left side of a patient's body will be taken as the intervention and those of the right side as the control group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Cutaneous lesions of the patients will be randomized into two groups of light blue or topical steroids using randomized blocks (1:1 allocation).
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 Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
IR.MUMS.REC.1391.304
Health conditions studied
1
Description of health condition studied
plaque psoriasis lesions
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Localized Psoriasis Severity Index
Timepoint
Before treatment and one week after the treatment is completed
Method of measurement
physical examination
Secondary outcomes
1
Description
Pigmentation
Timepoint
once a week in the course of treatment
Method of measurement
physical examination
2
Description
burning
Timepoint
once a week in the course of treatment
Method of measurement
physical examination
3
Description
redness
Timepoint
once a week in the course of treatment
Method of measurement
physical examination
Intervention groups
1
Description
Intervention Group (blue light ): In the intervention group, the lesions will be treated by light emitted from Lightcure device for 15 minutes per session 3 times weekly for 4 consecutive weeks.
Category
Treatment - Other
2
Description
Control Group (topical steroid): In the control group, lesions will be treated by a moderate topical steroid (fluocinnolone ointment 0.1 percent) every eight hours for 4 consecutive weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Ghaem Hospital
Full name of responsible person
Dr Pouran Layegh
Street address
Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3844 9060
Email
LayeghPo@mums.ac.ir
2
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Reza Hospital
Full name of responsible person
Dr Masoud Maleki
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 2000
Email
Maleki@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghod
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3282 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Zeinab Memarzadeh
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 5723
Email
MemarzadehZ931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 5723
Email
LayeghPo@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9797153577
Phone
+98 56 3239 5680
Email
hadirooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Deidentified Individual Participant Data Set will be provided in an excel file and provided on the research project website: http://yon.ir/xzDIR
When the data will become available and for how long
when the study is completed and for 5 years
To whom data/document is available
Those who refer to the project's website
Under which criteria data/document could be used
Only for research purposes
From where data/document is obtainable
the research website addressed at http://yon.ir/xzDIR
What processes are involved for a request to access data/document
If a request is delivered via email, the deidentified data file will be sent within 10 days.