Association of response to doxycycline and Azithromycin antibiotics therapy and IL-4 gene ( SR8179190) polymorphism in patients with moderate acne vulgaris
Determining the relationship between doxycycline and azithromycin antibiotic treatment and IL_4 gene polymorphism in patients with moderate acne vulgaris referred to skin clinics in Gonabad city in 2023-2024
Design
The trial with parallel groups, phase two will be conducted on 54 patients, dividing patients into study groups based on random allocation (block).
Settings and conduct
Patients with moderate acne who refer to Gonabad skin clinics are divided into two groups of 27 people and treatments are assigned, photography and determination of Michelson's acne score and patient satisfaction level before and after acne treatment will be done and after completion During the treatment period, 2 ml of blood will be taken from each person and polymorphisms will be checked. After checking the presence of mutation we will investigate the relationship between homozygous/heterozygous Burden and response to treatment
Participants/Inclusion and exclusion criteria
Entry criteria: suffering from acne vulgaris with moderate severity according to the classification system (MAS score); suffering from acne vulgaris with moderate severity according to the Weichamp classification system; age over 12 years old. Exit criteria: failure to complete the treatment process by the patient; occurrence of unusual complications during the treatment; patient's refusal to continue the treatment process.
Intervention groups
One group will receive doxycycline along with local treatment (benzoyl peroxide and tretinoin) and the other group will receive azithromycin along with local treatment (benzoyl peroxide and tretinoin).
Main outcome variables
Acne severity; recovery from the doctor's opinion; satisfaction level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057631N1
Registration date:2023-05-24, 1402/03/03
Registration timing:registered_while_recruiting
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Younes Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3429 3933
Email address
1377younes@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-13, 1401/12/22
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Association of response to doxycycline and Azithromycin antibiotics therapy and IL-4 gene ( SR8179190) polymorphism in patients with moderate acne vulgaris
Public title
Association of response to doxycycline and Azithromycin antibiotics therapy and IL-4 gene ( SR8179190) polymorphism in patients with moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acne vulgaris with moderate severity according to the classification system (MAS score)
Acne vulgaris with moderate severity according to vaishampayan classification system
Age over 12 years
Exclusion criteria:
Failure to complete the treatment process by the patient
Occurrence of unusual complications during treatment
The patient's refusal to continue the treatment process
Age
From 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, at first, the people who meet the criteria to enter the study will be selected to participate in the study based on their consent, and then the people will be divided into two intervention groups in the form of block allocation. In order to assign patients to two treatment groups, the Blocked Randomization method with blocks of four will be used. First, six possible states of blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed and a number from one to six is assigned to each block. Then, numbers between one and six are randomly selected using a table of random numbers, and then people are assigned to the azithromycin (A) and doxycycline (B) group based on the block corresponding to the selected number, and this work is done until completion. The sample size will continue.
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, near Asabi Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.GMU.REC.1401.138
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Response to treatment
Timepoint
Before starting the treatment, after the end of the treatment
Method of measurement
MAS score
2
Description
Satisfaction level
Timepoint
Before starting the treatment, after the end of the treatment
Method of measurement
check list
3
Description
Recovery from the doctor's opinion
Timepoint
Before starting the treatment, after the end of the treatment
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The first group receives doxycycline 100 mg daily along with topical treatment (benzoyl peroxide and tretinoin).
Category
Treatment - Drugs
2
Description
Intervention group: At first, the patients were examined by a dermatologist and the severity of their acne was measured based on the Michelson acne score, and the patients were subjected to standard photography. Next, the patients are divided into two groups. The second group receives 250 mg of azithromycin every other day along with topical treatment (benzoyl peroxide and tretinoin).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Hamideh Mohammadzadeh
Street address
Bohlool hospital, Parastar Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3028
Email
Mohammadzadeh.hamideh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Leila Sadegh Moghadam
Street address
Gonabad University of Medical Sciences, Dr Mehdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797952
Phone
+98 51 5722 3028
Email
Mohammadzadeh.hamideh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Hamide Mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlool hospital, Parastar Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-97852
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamide Mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlool hospital, Parastar Blvd.
City
gonabad
Province
Razavi Khorasan
Postal code
96917-97852
Phone
+98 51 5728 6832
Email
Mohammadzadeh.hamideh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamide Mohammadzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlool hospital, Parastar Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-97852
Phone
+98 51 5723 6832
Email
Mohammadzadeh.hamideh@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All the data will be provided to the researchers without names and specifications.
When the data will become available and for how long
After completing the research project and publishing the article
To whom data/document is available
All researchers
Under which criteria data/document could be used
To conduct similar research, researchers can access the results of the project by referring to the research assistant of Gonabad University of Medical Sciences with a written consent letter from the research assistant.
From where data/document is obtainable
Research assistant of Gonabad University
What processes are involved for a request to access data/document
Researchers can have access to the results of the project by referring to the vice president of research of Gonabad University of Medical Sciences with a written consent letter from the vice president of research.