Comparison the efficacy of topical Rosemary4% (Rosmarinus Officinalis) solution with topical Erythromycine 4% solution in the treatment of mild to moderate Acne Vulgaris
The main aim of this study is to evaluate the efficacy of Rosemary 4% solution in comparison with standard treatment of Acne Vulgaris in Iran.
For this purpose we selected patients with Acne Vulgaris with history of maximum five years suffering. The candidate was not receiving any medication. Pregnant and breastfeed patients were Considered as Exclusion Criteriaes.
This study was estimated to be done in nine months in dermatology clinic in Ahwaz Imam Khomeini Hospital. Upon the researched articles and the estimated effect of Rosemary on Acne Vulgaris in the sample size was calculated as sixty patients.
This study is a double blind randomized clinical trial. The total lesion count of Acne Vulgaris is the Primary outcome in this study (Papule Pustule and Comedo ).The side effect of Rosemary (Erythema , Dryness, Irritation, Bleeding, Skin Pigmentation and Hypo and Hyperbaric) is Considered the Secondary outcome. The patients are advised to apply solution twice a day on Acne’s lesion . The patients were photographed every two weeks as a document .The total Acne’s lesions were counted in the same period (two weeks) of time .The result would be evaluate by the data Analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110317962N1
Registration date:2012-06-21, 1391/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-21, 1391/04/01
Registrant information
Name
Afshin Kazerouni
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8383
Email address
kazerouni.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of topical Rosemary4% (Rosmarinus Officinalis) solution with topical Erythromycine 4% solution in the treatment of mild to moderate Acne Vulgaris
Public title
Treatment Of Facial Acne By Topical Rosemary
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion Criteria:Age No Limit; Both Sexes; Severity Of Acne Mild To Moderate Acne)(Exclusion Criteria:Pregnancy; History Of Anti Acne Treatment;Duration More Than 5 Years)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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,Daneshgah Square, Golestan Boulevard
City
Ahvaz
Postal code
6135715794
Approval date
2011-10-08, 1390/07/16
Ethics committee reference number
ETH-236
Health conditions studied
1
Description of health condition studied
Mild to moderate Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne Vulgaris
Primary outcomes
1
Description
Clinical index including the number of Comedones
Timepoint
Every two weeks
Method of measurement
Count the lesions
2
Description
Clinical index including the number of Papules
Timepoint
Every two weeks
Method of measurement
Count the lesions
3
Description
Clinical index including the number of Pustules
Timepoint
Every two weeks
Method of measurement
Count the lesions
Secondary outcomes
1
Description
Symptoms include redness, dryness, irritation, bleeding, skin pigmentation and hypo and hyperbaric
Timepoint
Every two weeks
Method of measurement
Physical examination
Intervention groups
1
Description
Topical solution of Rosemary 4%, 2 times daily for 2 months, Topical use on Facial Acne
Category
Treatment - Drugs
2
Description
Topical solution of Erythromycin 4%, 2 times daily for 2 months, Topical use on Facial Acne
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department Of Dermatology,Ahwaz Imam Khomeini Hospital
Full name of responsible person
Afshin Kazerouni
Street address
Department Of Dermatology,Ahwaz Imam Khomeini Hospital,Shahid Ahvazian Avenue,Azadegan Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research And Technology, Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University Of Medical Sciences,Daneshgah Square, Golestan Boulevard
City
Ahwaz
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 And Technology, 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
Afshin Kazerouni
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences,Daneshgah Square, Golestan Boulevard
City
Ahwaz
Postal code
6135715794
Phone
+98 61 1373 8383
Fax
+98 61 1336 1544
Email
kazerouni.a@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr.Reza Yaghobi
Position
Ph.D. In Dermatology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences,Daneshgah Square, Golestan Boulevard
City
Ahwaz
Postal code
6135715794
Phone
+98 61 1373 8383
Fax
+98 61 1336 1544
Email
kazerouni.a@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Afshin Kazerouni
Position
Resident Of Dermatology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences,Daneshgah Square, Golestan Boulevard
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8383
Fax
+98 61 1336 1544
Email
kazerouni.a@ajums.ac.ir
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)