Comparing the therapeutic efficacy of oral azithromycin plus Narrow Band Ultraviolet B (NBUVB) with oral azithromycin alone in the treatment of moderate to sever inflammatory facial acne vulgaris
To compare therapeutic efficacy of oral azithromycin plus Narrow Band Ultraviolet B (NBUVB) with oral azithromycin alone in the treatment of moderate to sever inflammatory facial acne vulgaris. Inclusion criteria: 15-35 Years old patient with moderate to sever inflammatory vulgaris. Exclusion criteria: 1-Pregnancy and breastfeeding; 2-History of topical and systemic anti acne treatment from 1 month ego; 3-Photosensitivity. 94 cases were randomly assigned to two groups: group 1, systemic azithromycin 500 mg every other day and group 2, systemic azithromycin 500 mg every other day plus NBUVB 1200 mj/sec two times weekly for one month. We compared the improvement rate of inflammatory acne lesions totally and differentially between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112288550N1
Registration date:2012-02-04, 1390/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-04, 1390/11/15
Registrant information
Name
Esmaeil Rafiee
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0699
Email address
rafiee.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-11-24, 1390/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic efficacy of oral azithromycin plus Narrow Band Ultraviolet B (NBUVB) with oral azithromycin alone in the treatment of moderate to sever inflammatory facial acne vulgaris
Public title
Narrow Band Ultraviolet (NBUVB) effect on the treatment of inflammatory acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Mail and female patent with moderate to sever inflammatory vulgaris. Exclusion criteria: 1-Pregnancy and breastfeeding; 2-History of topical and systemic anti acne treatment from 1 month ego; 3-Photosensitivity.
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61335-4156
Approval date
2011-02-21, 1389/12/02
Ethics committee reference number
ETH054
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
inflammatory acne lesions (totally and differentially)
Timepoint
1 month
Method of measurement
lesion count
Secondary outcomes
1
Description
patient's satisfaction of treatment
Timepoint
1 month
Method of measurement
Patient idea
Intervention groups
1
Description
Group 2: systemic azithromycin 500 mg every other day and NBUVB 1200 mj/sec two timesd weekly for one month.
Category
Treatment - Devices
2
Description
Group 1: systemic azithromycin 500 mg every other day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeiny hospital
Full name of responsible person
Dr Esmaeil Rafiee, resident of dermatology
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Esmaeil Rafiee
Position
Resident of dermatology
Other areas of specialty/work
Street address
Emam khomeini hospital
City
Ahvaz
Postal code
61335-4156
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
esmail.rafiee@gmail.com , rafiee.e@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Esmaeil Rafiee
Position
Rresident of dermatology
Other areas of specialty/work
Street address
Emam khomeini hospital
City
Ahvaz
Postal code
61335-4156
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
esmail.rafiee@gmail.com , rafiee.e@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)