Effect of topical compound of erythromycin with zinc acetate versus topical erythromycin on treatment of mild to moderate acne vulgaris: a double-blind randomized clinical trial
To assess the effect of topical compound of erythromycin with zinc acetate versus topical erythromycin on treatment of mild to moderate acne vulgaris
Design
This is a double-blind randomized clinical trial, phase III, in which 82 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with mild to moderate acne vulgaris referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 12 to 75 years;
Mild to moderate acne vulgaris;
Exclusion criteria:
Pregnancy or breastfeeding;
Sensitivity to erythromycin or zinc acetate;
History of taking oral isotretinoin during the last 6 months;
History of taking oral estrogen compounds during the last 3 months;
History of using retinoid and antibiotic compounds during the last 1 month;
History of using antimicrobial soap and topical exfoliators during the last 2 weeks;
Chronic skin diseases such as psoriasis, lichen planus, and vitiligo;
Immunodeficiency disorder or using immunosuppressive drugs
Intervention groups
Intervention group:
Topical compound of erythromycin 4% and zinc acetate 1.2% twice daily for 3 months
Control group:
Topical compound of erythromycin 4% twice daily for 3 months
Main outcome variables
Primary outcome:
Severity of acne lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N397
Registration date:2021-05-26, 1400/03/05
Registration timing:registered_while_recruiting
Last update:2021-05-26, 1400/03/05
Update count:0
Registration date
2021-05-26, 1400/03/05
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
2021-05-22, 1400/03/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical compound of erythromycin with zinc acetate versus topical erythromycin on treatment of mild to moderate acne vulgaris: a double-blind randomized clinical trial
Public title
Effect of topical compound of erythromycin with zinc acetate versus topical erythromycin on treatment of mild to moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 12 to 75 years,
Mild to moderate acne vulgaris
Exclusion criteria:
Pregnancy or breastfeeding,
Sensitivity to erythromycin or zinc acetate,
History of taking oral isotretinoin during the last 6 months,
History of taking oral estrogen compounds during the last 3 months,
History of using retinoid and antibiotic compounds during the last 1 month,
History of using antimicrobial soap and topical exfoliators during the last 2 weeks,
Chronic skin diseases such as psoriasis, lichen planus, and vitiligo,
Immunodeficiency disorder or using immunosuppressive drugs
Age
From 12 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
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, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.UMSHA.REC.1400.120
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
Severity of acne lesions
Timepoint
Before the intervention and 1 and 2 and 3 months after the intervention
Method of measurement
Using the Global Acne Grading System (GAGS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical compound of erythromycin 4% and zinc acetate 1.2% twice daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: Topical compound of erythromycin 4% twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Zahra Moradhaseli
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
dr.zahra.m1368@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid 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 Zahra Moradhaseli
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.zahra.m1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sobhan
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mreza_sobhan@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, Shahid 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