Comparison efficacy of IPL (Intense pulsed light) combined with oral azithromycin with oral azithromycin alone in the treatment of modrate to sever papulopustular Acne vulgaris.
The aim of this study is to compare the effects of oral azithromycin with IPL with oral azithromycin alone in treating moderate to severe papulopustular acne vulgaris. This study is a randomized, single-center study without placebo-controlled groups. Patients with moderate to severe acne, ranging between 18 to 40 years of age will be enrolled in the study. Patients with a history of connective tissue disease, pregnancy and lactation will be excluded. Forty patients with acne vulgaris referred to Sina hospital, randomly (interlaced) will be divided into two parallel groups of intervention and control. Informed consents will be filled out by participating patients. The intervention group will be treated with azithromycin 250 mg orally per day and IPL once a week, for 5 weeks. The control group will receive only azithromycin 250 mg orally per day. The number of papules and Pustules will be recorded at the beginning and at the end of the study. The primary outcome measure will be reduced number of lesions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701099844N4
Registration date:2017-06-20, 1396/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of IPL (Intense pulsed light) combined with oral azithromycin with oral azithromycin alone in the treatment of modrate to sever papulopustular Acne vulgaris.
Public title
The effect of laser in the treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with moderate to severe acne; Age ranges between 18 to 40 years.
Exclusion criteria: A history of connective tissue disease; Pregnancy and lactation (breast-feeding); a previous history of keloids and hypertrophic scars; Photosensitivity; History of Isotretinoin consumption during the past 6 months.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Third floor, Central Building 2 , Tabriz Medical Sciences University, Gholgasht ave , Tabriz
City
Tabriz
Postal code
5163639888
Approval date
2016-11-07, 1395/08/17
Ethics committee reference number
IR.TBZMED.REC.1395.938
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
Timepoint
week zero and third month
Method of measurement
Counting
Secondary outcomes
1
Description
Number of papule and Pustule
Timepoint
week zero and third month
Method of measurement
Counting
Intervention groups
1
Description
They will Treat with azithromycin 250 mg orally per day and IPL. IPL will perform weekly for 5 weeks for patients in the intervention group. Treatment period is 3 months.
Category
Treatment - Other
2
Description
Control group: Only receive azithromycin 250 mg orally per day.
Treatment period is 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Tabriz Sina Hospital
Full name of responsible person
Niloofar Afshari
Street address
between Montazeri Intersection and Hafez St,Azadi Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanscellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice chanscellor for research, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, , Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanscellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Mehdi Amirnia
Position
Dermatologist
Other areas of specialty/work
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Postal code
5163639888
Phone
+98 41 3540 6612
Fax
+98 41 3540 6612
Email
amirniam@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Dermatologist
Other areas of specialty/work
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Postal code
5163639888
Phone
+98 41 3540 6612
Fax
+98 41 3540 6612
Email
amirniam@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Niloofar Afshari
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Postal code
5163639888
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)