Evaluation of topical adjuvant treatment of psoriasis with recombinant Epidermal Growth Factor to control the e-regulation of the Epidermal Growth Factor Receptor (EGFR): clinical trial phase 2
Evaluation of topical cream containing recombinant epidermal growth factor on patients with psoriasis
Design
21 patients with two active plaque in the second phase of the clinical trial will be randomly assigned. To avoid disparity between group sizes, we will use replacement randomization until we achieve a balanced group size. The intervention area will receive a cream containing recombinant epidermal growth factor and the control group will receive cream without growth factor. The evaluation will be continued twice a day for a month.
Settings and conduct
The study will be performed at the skin and stem cell research center, Tehran University of Medical Sciences. In this study, participants and data collectors will be blind to the type of topical cream.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: - Informed consent - Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application - Age 18-60 years
Exclusion Criteria: - Systemic psoriasis treatment 3 months prior and during the study - Local psoriasis treatment on the investigational sites in the last 30 days or during the study - Known hypersensitivity or allergy to the EGF containing product and/or to Vaseline/10% salicylic acid - History of malignant disease or another clinically relevant concomitant disease state - Participation in another investigational drug study in the last 30 days
Intervention groups
Patients are randomly selected. Two active plaques will be selected by a physician on two separate areas of the body. The intervention area will receive a cream containing 5% recombinant epidermal growth factor and another plaque will receive cream without epidermal growth factor as a control group.
Main outcome variables
Change to baseline in target lesion severity score (PASI)
General information
Reason for update
Acronym
EGF; EGFR
IRCT registration information
IRCT registration number:IRCT20141007019432N8
Registration date:2022-03-12, 1400/12/21
Registration timing:prospective
Last update:2022-03-12, 1400/12/21
Update count:0
Registration date
2022-03-12, 1400/12/21
Registrant information
Name
Mohammadamir Amirkhani
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
amirkhani@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical adjuvant treatment of psoriasis with recombinant Epidermal Growth Factor to control the e-regulation of the Epidermal Growth Factor Receptor (EGFR): clinical trial phase 2
Public title
Epidermal Growth Factor adjuvant therapy for psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for self product application
Age 18-60 years
Exclusion criteria:
Systemic psoriasis treatment 3 months prior and during the study
Local psoriasis treatment on the investigational sites in the last 30 days or during the study
Known hypersensitivity or allergy to the EGF containing product and/or to Vaseline/10% salicylic acid
History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, this method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = Active, Tails = Placebo. Implementation and treatment of assignments are completely unpredictable.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.962
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Measure of Psoriasis Area and Severity Index (PASI)
Timepoint
before intervention and 1
Method of measurement
Psoriasis Area and Severity Index (PASI) based on the standard
Secondary outcomes
1
Description
Skin quality
Timepoint
Before intervention and 1
Method of measurement
Ultrasound skin imaging
Intervention groups
1
Description
Intervention group: The intervention group will receive a topical cream containing 5% recombinant epidermal growth factor, twice a day for a month.
Category
Treatment - Drugs
2
Description
Control group: the group will be received topical cream which is standard care containing: clobetasol 30gr, urea 15gr, distilled water 15 cc, salycilic acid 1.5 % and eucerin up to100gr, without epidermal growth factor, twice a day for a month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center of Tehran University and Medical Sciences
Full name of responsible person
Mohammad Amir Amirkhani
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Nilforoushzadeh
Street address
Kamraniyeh Ave., Maryam deadend,
City
Teharn
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
dr_nilforoush@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadamir Amirkhani
Position
Project Manager - Medical Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Skin & Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
amirkhani@health.gov.ir
Web page address
http://311.rc.research.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadamir Amirkhani
Position
Project Manager - Medical Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Skin & Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
amirkhani@health.gov.ir
Web page address
http://311.rc.research.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadamir Amirkhani
Position
Project Manager - Medical Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Skin & Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
amirkhani@health.gov.ir
Web page address
http://311.rc.research.ac.ir/
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data collected for the primary outcome
When the data will become available and for how long
data relative to the time after finishing the data collection and 3 months after publication
To whom data/document is available
available for people working in an academic institution
Under which criteria data/document could be used
There is no specific criteria
From where data/document is obtainable
People can send an email to get more information
What processes are involved for a request to access data/document
After requesting the data, you will get an email with information