To assess the effect of brimonidine tartrate gel 0.33% versus tretinoin cream 0.05% on post-acne erythema
Design
This is a Phase III single-blind randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 90 eligible patients with Acne. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Erythema after acne
Exclusion criteria:
Pregnancy or breastfeeding
Taking anti-acne drugs in the last 3 months
Contraindications to Brimonirin (including treatment failure, brain failure, depression, blood pressure, scleroderma, Sjogren's syndrome, Raynaud's phenomenon)
Intervention groups
Intervention group:
Brimonidine tartrate gel 0.33% once a day topically at the site of acne erythema for 4 weeks
Control group:
Tretinoin cream 0.05% once a day topically at the site of acne erythema for 4 weeks.
Main outcome variables
Primary outcome:
Severity of post-acne erythema
Skin burning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N490
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of brimonidine tartrate gel 0.33% versus tretinoin cream 0.05% on post-acne erythema: a single-blind randomized clinical trial
Public title
Effect of brimonidine tartrate gel 0.33% versus tretinoin cream 0.05% on post-acne erythema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Erythema after acne
Exclusion criteria:
Pregnancy or breastfeeding
Taking anti-acne drugs in the last 3 months
Contraindications to Brimonirin (including treatment failure, brain failure, depression, blood pressure, scleroderma, Sjogren's syndrome, Raynaud's phenomenon)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The form of the drugs is completely the same, so that patients do not know which gel or cream is brimonidine or tretinoin. Consequently, patients will remain unaware of the type of intervention they receive. Therefore, the trial will be conducted as a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-11-04, 1402/08/13
Ethics committee reference number
IR.UMSHA.REC.1402.510
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Severity of post-acne erythema
Timepoint
Before the intervention and in the fourth and eighth weeks after the intervention
Method of measurement
By clinical examination
Secondary outcomes
1
Description
Skin burning
Timepoint
In the fourth and eighth weeks after the intervention
Method of measurement
By taking a history
Intervention groups
1
Description
Intervention group: Brimonidine tartrate gel 0.33% once a day topically at the site of acne erythema for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Tretinoin cream 0.05% once a day topically at the site of acne erythema for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Roshanak Kazemirad
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
Karadr26@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Roshanak Kazemirad
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Karadr26@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jamshidi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
jamshidim84@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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