Comparing the effect of Doxycycline versus Metformin and in treatment of moderate acne patients.
Design
This study is a phase 3, randomized, double blinded clinical trial study.40 patients will be selected from the patients of Shiraz Shahid Faghihi Hospital dermatology office. sample size will be determined by NCSS software, power: 90% , p-value: 5% and by using similar previous study. the participants will be divided into 2 parallel groups, intervention and control groups, by using sealed envelope online Random allocation.
Settings and conduct
Doxycyclin and Metformin will give to the patients according to the block randomization table monthly for 2 months. The clinical evaluator of the study will not know which patients received any of the drugs mentioned in the study. This study lacks a placebo and the effects of the two drugs are compared.
Participants/Inclusion and exclusion criteria
16-40 years old patients with moderate acne or acne that needs systemic antibiotic are included in the study. they should not have been treated with systemic medications since 1 month ago and should not have been treated with topical therapy since 2 weeks ago. the patients with history of hypersensitivity to the mentioned drugs and who can not come regularly for follow up are excluded. pregnant an breast feeding mothers and also patients with systemic diseases are excluded.
Intervention groups
The participants are divided into 2 groups. the control group will receive Doxycycline(Abidi company) 100mg per day 2 hours after meal. the intervention group will receive Metformin (Rasta Imen Daroo company) 500mg twice daily. both groups should use topical 5% benzoyl peroxide (Pangel) on the lesions every night.
Main outcome variables
Acne severity, response to treatment, the effect of acne on the patient's life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049309N1
Registration date:2022-06-07, 1401/03/17
Registration timing:retrospective
Last update:2022-06-07, 1401/03/17
Update count:0
Registration date
2022-06-07, 1401/03/17
Registrant information
Name
Nazafarin Yazdanpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 7434
Email address
nazafarin.yazdanpanah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-14, 1399/09/24
Expected recruitment end date
2021-02-12, 1399/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Metformin in comparison with Doxycycline in treatment of patients with Acne Vulgaris skin disease.
Public title
Effect of Metformin in Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
16-40 years old patients with moderate acne .
They should not have been treated with systemic medications since 1 month ago.
They should not have been treated with topical therapy since 2 weeks ago.
Exclusion criteria:
The patients with a history of hypersensitivity to metformin and doxycycline. . Patients with systemic diseases are excluded.
The patients with systemic disease
The pregnant and lactating women
Age
From 16 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Metformin and Doxycline will be put in alike boxes and by using sealed envelope online system block randomization will be done and the code of block randomization will be put on the boxes. drugs will be given to the participants monthly and the codes will not be clarified until the end of research (allocation concealment)
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different forms of drugs, patients and clinical caregivers who deliver drugs to patients are not blind. But the clinical assessor blind to how patients intervene
Placebo
Not used
Assignment
Parallel
Other design features
All details and explanation are written in specific part.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Ave, medical university, ethics comittee
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.SUMS.MED.REC.1399.459
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.9
ICD-10 code description
Acne, unspecified
Primary outcomes
1
Description
acne severity
Timepoint
before treatment and 1,2 months after treatment
Method of measurement
Global acne grading system,burke and cunliffe and counting total lesion count
Secondary outcomes
1
Description
response to treatment
Timepoint
at the onset and 2 months after treatment
Method of measurement
asking patient himself
2
Description
effect of acne on patient life
Timepoint
before treatment and 2 months after treatment
Method of measurement
Cardiff Acne disability index method
Intervention groups
1
Description
Intervention group: Intervention group: Apometformin 500 mg twice daily+ topical benzoyl peroxide 5% (pangel) on the lesions every other night for 2 months
Category
Treatment - Drugs
2
Description
Control group: Doxycycline (Hakim company) 100 mg daily for 2 months + benzoyl proxide 5%gel(pangel) every other night on acne lesions ; the Intervention group: Metformin (Abidi Company) 500mg daily for 2 months +benzoyl proxide 5%gel(pangel) every other night on acne lesions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Molecular dermatology Research center, Shiraz University of Medical sciences
Full name of responsible person
Nazafarin Yazdanpanah
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Fax
+98 71 3231 9049
Email
Nazafarin.yazdanpanah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Shiraz, zand street, shiraz university of medical sciences, 7th floor, vice chancellor of research
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@suma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nazafarin Yazdanpanah
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
Nazafarin.yazdanpanah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nazafarin Yazdanpanah
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
Nazafarin.Yazdanpanah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nazfarin Yazdanpanah
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
nazafarin.yazdanpanah@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After the publication of the extracted article of the clinical
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document