Evaluation of the effect of topical application of your seed oil on contact dermatitis
Design
This study is a triple-blind randomized clinical trial study performed on 68 patients with mild to moderate contact hand dermatitis. flaxseed cream will be prepared in the Faculty of Pharmacy, University of Tehran, and it will be matched with eucerin cream prepared in terms of color, appearance and smell. The tubes are coded by someone outside the study.
Patients will be selected by a physician in dermatology research centers of medical universities. Patients in two groups of flaxseed oil (A) and eucerin (B)will be randomized using a table of random numbers as a block randomization
Settings and conduct
Patients will be selected based on physical examination, family and personal history with Hanifin and Rajka criteria by a physician in dermatology research centers of medical universities.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The patient's cooperation to eliminate or reduce environmental irritants and is bound to cooperate for regular use of the drug under study and referral at the appointed time after signing the informed consent form
2. Having symptoms of hand contact dermatitis
3. Age over 5 years up to 70 years
4. Do not take anti-allergy and anti-itch drugs
Exclusion criteria:
1. History of neurological and mental illness
2. Specific skin sensitivity
3. The use of systemic anti-allergy, anti-pruritic and immunosuppressive drugs
4. Use of topical medications during the 2 weeks before the start of the research project,
5. Having obsessive-compulsive and practical diseases for frequent hand washing,
6. Use of systemic immunosuppressive drugs during the month before the start of the study,
Intervention groups
two groups A and B Flaxseed oil and eucerin cream group
Comparison between Flaxseed oil and Eucerin in improving the symptoms of Hand contact dermatitis
Public title
Effect of Flaxseed oil in hand dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's cooperation to eliminate or reduce environmental irritants and is bound to cooperate for regular use of the drug under study and referral at the appointed time after signing the informed consent form
Having symptoms of moderate contact dermatitis
Age over 5 years up to 70 years
Do not take anti-allergy and anti-itch drugs
Exclusion criteria:
History of neurological and mental illness
Specific skin allergies
Taking systemic anti-allergy, anti-pruritic and immunosuppressive drugs
Use of topical medications during the 2 weeks before the start of the research project,
Having obsessive-compulsive disorder for frequent hand washing,
Use of systemic immunosuppressive drugs one month before the start of the study,
Age
From 5 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on physical examination, family and personal history with Hanifin and Rajka criteria by a physician in dermatology research centers of medical universities. After explaining the objectives of the study and obtaining informed written consent, a detailed history and clinical examination were performed. Patients in two groups of flaxseed oil and osrine (both products are prepared as a cream in the laboratory of Tehran School of Pharmacy) will be randomized in two groups A and B as a randomization block using the table of random numbers. Flaxseed oil and osrine cream group
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a triple -blind randomized clinical trial study performed on 68 patients with mild to moderate contact dermatitis. First, flaxseed is prepared from the market of medicinal plants and then it has been oil extracted in a reputable lubrication center. Flaxseed and eucerin are placed in tubes that will be identical in appearance. The tubes are coded by someone outside the study, and the patient, researcher, and pharmacist do not know the contents of the drug.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
معاونت فناوری و تحقیقات دانشگاه علوم پزشکی قم
Secondary trial Id
2263
Registration date
2021-04-18, 1400/01/29
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83Shahid Mohammad Mehdi Lotfi Niasar Alley (Alley 4)University Jihad St.Safa Shahr St. - Qom
City
Qom
Province
Markazi
Postal code
3716993456
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.MUQ.REC.1401.023
Health conditions studied
1
Description of health condition studied
Hand contact dermatitis
ICD-10 code
hand conta
ICD-10 code description
hand contact dermatitis
Primary outcomes
1
Description
erythem
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
2
Description
papule
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
3
Description
vesicle
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
4
Description
fissure
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
5
Description
Scaling
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
6
Description
edema
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on HECSI questionnaires.
Secondary outcomes
1
Description
Patients' quality of life index
Timepoint
Patients are examined at the beginning of the study and at the end of the first week and then at the end of the second and fourth weeks
Method of measurement
Will be examined based on DLQI questionnaires
Intervention groups
1
Description
Intervention group: The dose of the drug for each hand is 1 gram, which is explained to the patient in the form of a fingertip unit (from the skin folds of the adult finger to the tip of the adult finger), so that a fingertip unit (1g) Use topical medicine for each hand. . Before using the topical medicine, the hands should be cleansed of any substances and contaminants, and hand washing and cleaning the topical medicine should be avoided for at least one hour after using the medicine. The duration of drug administration for the patient will be one month and patients participating in this group will be evaluated at the beginning of the study and also every two weeks (end of week 2 and end of week 4 from the start of drug administration) (the patient Will not know the treatment method.).The drug (flaxseed oil cream based on 30% flaxseed oil) is prepared in the Faculty of Pharmacy, University of Tehran.
Category
Placebo
2
Description
Control group: The dose of placebo (eucerin) for each hand is 1 gram, which is explained to the patient in the form of a fingertip unit (from the skin folds of the adult finger to the tip of the adult finger), so that a fingertip unit ( 1 g) Use topical eucerin , which is provided by Farabi Pharmaceutical Company, for each hand. . Hands should be cleaned of any contaminants and contaminants before use, and hand washing and placebo should be avoided for at least one hour after using the drug. The duration of placebo use for the patient will be one month and patients participating in this group will be evaluated at the beginning of the study and once every two weeks (end of week 2 and end of week 4 from the start of drug use) Will not know the treatment method.).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Research Center, University of Tehran
Full name of responsible person
Saeed dadashi
Street address
Tehran, Sadr Highway, Pashazahri St. (South Kamaranieh), not far from Kamranieh intersection, Maryam dead end, No. 4, second floor
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Email
drsdadashi80@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza koohpaei
Street address
No. 83Shahid Mohammad Mehdi Lotfi Niasar Alley (Alley 4)University Jihad St.Safa Shahr St. - Qom
City
Qom
Province
Markazi
Postal code
3716993456
Phone
+98 25 3285 4011
Email
eduss@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Saeed Dadashi
Position
Resident of traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine , corner of Alley 44,15 Khordad St. , Qom,,
City
Qom
Province
Markazi
Postal code
371484835
Phone
+98 25 3776 4074
Email
admin@irct.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
fateme Aliasl
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, - Corner of Alley 44,15 Khordad St. Qom
City
qom
Province
Markazi
Postal code
37148435
Phone
+98 25 3776 4074
Email
aliasl1392@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Saeed Dadashi
Position
Assistant to traditional medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine , Corner of Alley 44,15 Khordad St. - Qom,
City
Qom
Province
Markazi
Postal code
3714848350
Phone
+98 25 3776 4074
Email
drsdadashi80@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
The clinical study report will be published in the form of an article
When the data will become available and for how long
The clinical study report will be available 6 months after the results are published
To whom data/document is available
University researchers
Under which criteria data/document could be used
It is possible to use the results of the study for other research projects in collaboration with the project manager and Qom University of Medical Sciences
From where data/document is obtainable
Contact the executor of the research project
What processes are involved for a request to access data/document