Association of response to doxycycline and Azithromycin antibiotics therapy with Angiotensin converting enzyme polymorphism in patients with moderate acne vulgaris
Determining the relationship between response to doxycycline and azithromycin antibiotic treatment with angiotensin-converting enzyme (ACE) gene polymorphism in patients with moderate acne vulgaris referred to Gonabad skin clinics in 2023
Design
Patients with moderate acne will be divided into two groups of 27 people, one group will receive doxycycline 100 mg daily along with topical treatment (benzoyl peroxide and tretinoin) and the other group will receive azithromycin 250 mg every other day along with topical treatment (benzoyl peroxide and tretinoin).Clinical trial without control group, with parallel groups, without blind strain, block randomization, and data will be analyzed after collection with statistical software SPSS version 22.
Settings and conduct
After obtaining consent from the patients and dividing them into two groups, one group will receive doxycycline and the other group will receive azithromycin, and then we will investigate the polymorphism.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Acne vulgaris with moderate severity according to the MAS SCORE classification system
2. Suffering from acne vulgaris with moderate severity according to Weishampain's classification system
3. Age over 12 years
Intervention groups
one group will receive doxycycline 100 mg daily along with topical treatment (benzoyl peroxide and tretinoin) and the other group will receive azithromycin 250 mg every other day along with topical treatment (benzoyl peroxide and tretinoin).
Main outcome variables
angiotensin converting enzyme gene polymorphism; Age; gender; treatment; rate of response to treatment; recovery from the doctor's point of view; the level of patient satisfaction; duration of acne; Family history of acne
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057628N1
Registration date:2023-03-14, 1401/12/23
Registration timing:registered_while_recruiting
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
alireza tavakolizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 7039
Email address
alirezatavakolizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-06-22, 1402/04/01
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 with Angiotensin converting enzyme polymorphism in patients with moderate acne vulgaris
Public title
Association of response to doxycycline and Azithromycin antibiotics therapy with Angiotensin converting enzyme polymorphism in patients with moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acne vulgaris with moderate severity according to the MAS SCORE classification system
Suffering from acne vulgaris with moderate severity according to Weishampain's classification system
Exclusion criteria:
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
Permuted block randomization, At first, the people who meet the criteria for entering the study will be selected based on the purpose after obtaining the consent to participate in the study, and then the people will be divided into two intervention groups in the form of block 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 gonabad university of medical sciences
Street address
House number 30, Imam Ali 2 street, gonabad city
City
gonabad
Province
Razavi Khorasan
Postal code
9691998984
Approval date
2023-02-26, 1401/12/07
Ethics committee reference number
IR.GMU.REC.1401.182
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
Angiotensin converting enzyme gene polymorphism
Timepoint
After the end of the treatment period
Method of measurement
PCR and electrophoresis
2
Description
Response to treatment
Timepoint
Before starting the treatment, after the end of the treatment
Method of measurement
MAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At first, the patients are examined by a dermatologist and the severity of their acne is measured based on the Michelson acne score, and the patients are 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 are examined by a dermatologist and the severity of their acne is measured based on the Michelson acne score, and the patients are 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, Gonabad city
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6832
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, Gonabad city
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797952
Phone
+98 51 5723 6832
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, Gonabad city
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
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
Gonabad city , parastar Blvd, bohlool hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۷۸۵۲_۹۶۹۱۷
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
Hamideh mahammas
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Bohlool hospital, Parastar Blvd, Gonabad city
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
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.