Comparison of the efficacy of Azithromycin and Doxycycline in cases of moderate intensity inflammatory papulopustular acne, a randomized clinical trial
Comparison of the efficacy of Azithromycin and Doxycycline in cases of moderate intensity inflammatory papulopustular acne
Design
This is a parallel randomized clinical trial that will perform on 140 patients with papulopustular acne. Randomization will perform with permuted blocked randomization using SPSS syntax. The block size will be 4. This study will enroll for 6 months.
Settings and conduct
This study will conduct as a clinical trial study with 140 patients who will refer to Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study. In this study; clinical caregiver and the analyzer will blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with moderate inflammatory papulopustular acne; Age range 15-50 years; and satisfaction with participation to the research.
Exclusion criteria: previous burns or local scars; doing restorative skin care like laser; Severe hormonal disorders such as hypothyroidism; Chronic liver and kidney disease; Pregnancy and lactation.
Intervention groups
Patients entered into the study are divided into intervention and control groups. In the intervention group; treatment with Azithromysin plus tertinoin topical lotion 0.5% will be prescribed in the third month. In the control group; treatment with just ferrous sulfate tablet in the third month will be performed.
Main outcome variables
Acne healing speed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N16
Registration date:2019-09-15, 1398/06/24
Registration timing:registered_while_recruiting
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Azithromycin and Doxycycline in cases of moderate intensity inflammatory papulopustular acne, a randomized clinical trial
Public title
Comparison of the efficacy of Azithromycin and Doxycycline in treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate inflammatory papulopustular acne,
Age range 15-50 years,
Satisfaction with the research.
Exclusion criteria:
Previous burns,
Severe hormonal disorders such as hypothyroidism,
Chronic liver and kidney disease,
Pregnancy and lactation,
doing restorative skin care like laser
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using permuted block randomization method using blocked random allocation syntax in SPSS software. For calculation sample size, number of blocks and block size was determined. Block size was 4. Allocation concealment was done using closed opaque envelope.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2017-08-31, 1396/06/09
Ethics committee reference number
IR.SHMU.REC.1396.155
Health conditions studied
1
Description of health condition studied
Acne conglobata
ICD-10 code
L70.1
ICD-10 code description
Acne conglobata
Primary outcomes
1
Description
Acne healing speed
Timepoint
Once every two weeks
Method of measurement
Skin imaging and global response assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using Azithromysin tablet (Pars darou Company) in a single dose (250 mg/day) orally for three months in addition using topical Tertinoin lotion 0.05% (Alborz company) twice a day (10 drops per 12 hours, locally) for three months.
Category
Treatment - Drugs
2
Description
Control group: Using of a Doxycycline capsule (Pars Darou company) twice a day orally (total 200 mg/ daily) in addition to topical Tertinoin lotion 0.05% (Alborz company) twice a day (10 drops per 12 hours, locally) for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Marjan Talebi
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
m_talebi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Marjan Talebi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
m_talebi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available