Acne vulgaris is a multi-factorial disorder of the pilosebaceous unit, which is characterized by comedones, Papules, Pustules, cysts and scars. Using antimicrobial (both systemic and topical) is a common therapy for acne. Azithromycin is a semi-synthetic and newer macrolide that is effective in the treatment of acne and has fewer side effects compared with the conventional medications; however, few studies have been so far done on its topical formulations. The aim of this study is to evaluate the efficacy and possible side effects of azithromycin gel 2% in comparison with clindamycin phosphate 1%. This study is a double-blind clinical trial designed to compare the right and left sides of the face. Inclusion criteria: patients with mild and moderate acne in acne FDA grading scale system, 12 to 45 years-old patients, not receiving any effective systemic treatment of acne for one month prior to and during the study, and no history of any hypersensitivity to the study's medications. 40 patients with acne underwent treatment with azithromycin gel 2% and clindamycin gel 1% (of the same type and A & B labels) for two months and two times a day. Each of the gels was allocated to either left of right sides of the face based on the personal tendencies. Clinical improvement is evaluated based on enumeration of all lesions, acne severity index, and patients' satisfaction (10-point scale). The outcomes of the study will be measured at the fourth and eighth weeks of the treatment and then two months after the cessation of the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031216970N1
Registration date:2014-11-21, 1393/08/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-21, 1393/08/30
Registrant information
Name
AKRAM BASIRI
Name of organization / entity
ESFAHAN UNIVERSITY OF MEDICAL SIENCES
Country
Iran (Islamic Republic of)
Phone
0098
Email address
akrambasiri@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
azithromycin gel 2% in comparison with clindamycin gel 1% in acne vulgaris
Public title
Acne Treatment with topical gel azithromycin 2%
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with mild and moderate FDA acne grading system scale , aged 12 to 45 years, both sexes, written informed consent for participation in the study , not receiving topical antibiotics within two weeks and systemic medications that are effective in acne within a month prior to the study, no history of hypersensitivity to any of the studies medications. Exclusion criteria: pregnancy or lactation, medical allergy or side effects, non- cooperation or lack of satisfactory treatment, the need for systemic medication during the study or concomitant use of drugs affecting acne
Age
From 12 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ETHICS COMMITTEE OF ISFAHAN UNIVERSITY OF MEDICAL SCIENCES
Street address
VICE CHANCELLOR FOR RESEARCH OF ESFAHAN UNIVERSITY OF MEDICAL SCIENCES- HEZAR JERIB AVENUE
City
ISFAHAN
Postal code
Approval date
2013-10-30, 1392/08/08
Ethics committee reference number
392518
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
Beginning of the study design, 4th and 8th weeks of the treatment and 2 months after treatment
Method of measurement
Total count of lesions= TLC and acne severity index = ASI
2
Description
Patient satisfaction
Timepoint
4th and 8th weeks of treatment and 2 months after treatment
Method of measurement
Scale of 10 ratings
Secondary outcomes
1
Description
Burning and itching
Timepoint
4th and 8th weeks of treatment and 2 months after treatment
Method of measurement
A scale of 4 ratings
2
Description
Erythema
Timepoint
4th and 8th weeks of treatment and 2 months after treatment
Method of measurement
A scale of 4 ratings
3
Description
Dry
Timepoint
4th and 8th weeks of treatment and two months after treatment
Method of measurement
A scale of 4 ratings
4
Description
Desquamation and peeling
Timepoint
4th and 8th weeks of treatment and 2 months after treatment
Method of measurement
A scale of 4 ratings
5
Description
Recurrence
Timepoint
2 months after treatment
Method of measurement
index of severity of acne=ASI Total lesion count = TLC
Intervention groups
1
Description
Intervention group 1 =the use of gel azithromycin 2% on half of the face 2 times a day for 2 months
Category
Treatment - Drugs
2
Description
Intervention Group 2 (Control )=the use of gel clindamycin 1% on half of the face 2 times a day for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ALZAHRA HOSPITAL
Full name of responsible person
Dr AKRAM BASIRI
Street address
DEPARTMENT OF DERMATOLOGY -ALZAHRA HOSPITAL-SOFFEH BLVD-
City
ISFAHAN
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
VICE CHANCELLOR FOR RESEARCH OF ISFAHAN UNIVERSITY OF MEDICAL SCIENCES
Full name of responsible person
Dr EBRAHIM ESFANDIARI
Street address
VICE CHANCELLOR FOR RESEARCH OF ESFAHAN UNIVERSITY OF MEDICAL SCIENCES- HEZAR JERIB AVENUE
City
ISFAHAN
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
VICE CHANCELLOR FOR RESEARCH OF ISFAHAN 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
ISFAHAN UNIVERSITY OF MEDICAL SCIENCES-DEPARTMENT OF DERMATOLOGY
Full name of responsible person
DR. AKRAM BASIRI
Position
ASSISTANT OF DERMATOLOGY
Other areas of specialty/work
Street address
DEPARTMENT OF DERMATOLOGY -ALZAHRA HOSPITAL-SOFFEH BLVD-
City
ISFAHAN
Postal code
Phone
+98 31 3267 0694
Fax
+98 31 3668 4510
Email
akram basiri@med.mui.ac.ir ; AB13533@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
DEPARTMENT OF DERMATOLOGY - ISFAHAN UNIVERSITY OF MEDICAL SCIENCES
Full name of responsible person
DR. GITA FAGHIHI
Position
PROFESSOR OF DERMATOLOGY
Other areas of specialty/work
Street address
DEPARTMENT OF DERMATOLOGY -ALZAHRA HOSPITAL-SOFFEH BLVD-
City
ISFAHAN
Postal code
Phone
+98 31366855552563
Fax
+98 31 3668 4510
Email
g faghihi@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
ISFAHAN UNIVERSITY OF MEDICAL SCIENCES-DEPARTMENT OF DERMATOLOGY
Full name of responsible person
Dr . AKRAM BASIRI
Position
ASSISTANT OF DERMATOLOGY
Other areas of specialty/work
Street address
DEPARTMENT OF DERMATOLOGY -ALZAHRA HOSPITAL-SOFFEH BLVD-
City
ISFAHAN
Postal code
Phone
+98 31 3267 0694
Fax
+98 31 3668 4510
Email
akram basiri@med.mui.ac.ir ; AB13533@yahoo.com
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)