Different types of therapeutic regimens have been introduced for the treatment of Acne Vulgaris. One of the most common therapeutic methods is application of local antibiotics. The aim of this study was to compare the therapeutic effect of local Azithromycin with current local antibiotic regimens such as Clindamycin, and Erythromycin in the treatment of mild to moderate Acne Vulgaris. In this, randomized double-blind clinical trial, 96 patients with Acne Vulgaris was allocated into three groups. Pregnant and breast feeding women, children younger than 10 years, patients with severe acne or pervious anti-acne therapy in recent 4 weeks and patients using acne-inducing drugs were excluded. 2% alcoholic solution of Azithromycin, Erythromycin, and Clindamycin were prescribed to three groups under study for a 16-week period. Inflammatory and non-inflammatory lesions were counted, and the side effects assessed and recorded monthly during the study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706231245N1
Registration date:2009-04-19, 1388/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-19, 1388/01/30
Registrant information
Name
Zohreh Hajheidari
Name of organization / entity
Mazandaran University Of Medical Sciences(Vice-chancellor for research)
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
zhajheidari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences(Vice- chancellor for Research)
Expected recruitment start date
2006-04-30, 1385/02/10
Expected recruitment end date
2007-04-30, 1386/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of theraputic effects of topical Azithromycin , Erythromycin and Clindamycin for the treatment of acne vulgaris
Public title
The treatment of Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of mild to moderate Acne Vulgaris (up to 10 comedons, papular and/or pustular lesions). Exclusion criteria: pregnant and breast feeding women, children younger than 10 years old, severe cases of acne (existence of nodules and cysts), receiving anti acne during four weeks prior to study, taking acne creating drugs such as oral or local steroids, vitamin B12, anticonvulsive drugs.
Age
From 10 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Mazndaran University of Medical Sciences (Vice-chancellor for Research)
Street address
No. 2 University building, Moallem square
City
Sari
Postal code
4817844718
Approval date
2007-04-30, 1386/02/10
Ethics committee reference number
24-85
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 and noninflammatory lesions
Timepoint
Baseline and after 2,4,8, and 12 weeks
Method of measurement
counting lesions using manual lens
Secondary outcomes
1
Description
Reduction of lesions inflammatory and noninflammatory
Timepoint
Baseline and after 2, 4, 6, and 8 weeks
Method of measurement
ASI formula and total count rate
Intervention groups
1
Description
Topical Azithromycin, 2% alcohol solution, two times daily on the clean skin for 3 months
Category
Treatment - Drugs
2
Description
Topical Erythromycin and Clindamycin, 2% alcohol solution, two times daily on the clean skin for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali hospital and Dermatology offices in Sari
Full name of responsible person
Street address
Boali hospital, Pasdaran boulevard, Emam square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Zohreh Hajheidari
Street address
Emam square ,valie- asr boulevard
City
Sari
Grant name
30121
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences(Vice-chacellor for Research)
Full name of responsible person
Ravanbakhsh Esmaeeli
Position
Research adminstrator /Master of science on Nursing
Other areas of specialty/work
Street address
No. 2 University building. Moallem square
City
Sari
Postal code
4817844718
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
Esmaeeli2003@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences(Vice - chancellor for Research)
Full name of responsible person
Zohreh Hajheidari
Position
Skin and hair Specialist
Other areas of specialty/work
Street address
NO. 2 University building, Moallem square
City
Sari
Postal code
4817844718
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
zhajheidari@mazums.ac.ir
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra foroughi
Position
Librarian
Other areas of specialty/work
Street address
No. 2 University building, Moallem square
City
Sari
Postal code
4817844718
Phone
+98 15 1325 7230
Fax
+98 15 1326 1244
Email
z_foroughi@yahoo.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)