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Comparison‍‍‍‍ of efficacy of topical combination solution of salicylic acid 2% and erythromycin 4% with topical solution of erythromycin 4% alone in mild to moderate acne vulgaris treatment; double-blinded randomized clinical trial

Protocol summary

Summary
To compare the efficacy of topical combination solution of salicylic acid 2% and erythromycin 4% with topical solution of erythromycin 4% alone in mild to moderate acne vulgaris treatment, 50 patients with age range of 11-30 y/o, from both gender (male & female) are placed in tow groups (A&B) with simple randomization method. Patients under 11 y/o and over 30 y/o, using of topical or systemic steroids, using of anti-androgens, using of anti-acne drugs during previous month, having other face dermatosis and systemic acne accelerator diseases such as, PCO, are the exclusion criteria. Patients with mild to moderate acne, age rang of 11-30 y/o, patient's satisfaction, lack other face dermatosis, lack of systemic acne accelerator diseases are the inclusion criteria. In one group combination of 4 grams erythromycin and 2 grams salicylic acid in 10 cc propylene glycol and alcohol 70 degrees to the volume of the overall 100 cc, and in other group combination of 4 grams erythromycin in 10 cc propylene glycol and alcohol 70 degrees to the volume of the overall 100cc will be prescribed. Patients will be advised to apply the solution on their face, twice daily, with slight rubbing. The treatment duration will be 12 weeks. All patients will be recommended to use of oil-free sunscreen during the day. The patients will be visited at 15 day period for evaluation of reducing the number of lesions (comedons, papules & pustules), acne severity index,patient's satisfaction and side effects of treatment. In the end of study data will be collected and analyzed with statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010094269N3
Registration date: 2011-10-19, 1390/07/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-10-19, 1390/07/27
Registrant information
Name
Farideh Golfroushan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 2101
Email address
golfroushanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences and Health Services
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison‍‍‍‍ of efficacy of topical combination solution of salicylic acid 2% and erythromycin 4% with topical solution of erythromycin 4% alone in mild to moderate acne vulgaris treatment; double-blinded randomized clinical trial
Public title
Effect of combined topical solution 2% salicylic acid and erythromycin 4% with erythromycin 4% topical solution in the treatment of mild to moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:patients who are using topical or systemic steroids ; patients who are using contraceptive pills (anti-androgen); patients who are used topical or oral anti-acne medications, during the previous month, even include natural and UV light and Herbal and traditional acne treatments; if there are other face dermatosis and other systemic acne accelerator diseases such as Cushing's syndrome, PCO,adrenal hyperplasia, acquired and innate immun deficiency, steroid acne and acneiform lesions and ....; patient's dissatisfaction ;if there are more than 20 inflammatory lesions (papules and pustules) and three nodules or cysts on one side of the face ; patients with acne excoree ;age under 11 y/o andover 30 y/o ;if there is an inflammatory disease,except acne, on the face such as contact dermatitis, allergic or seborrheic dermatitis and... Inclusion criteria:patients with mild to moderate acne in age range 11-30 years old ; patients who have maximum 20 inflammatory lesions (papules &pustule) on one side of the face and have not more than three nodules or cysts on the same side of the face; lack of other face dermatosis such as contact dermatitis, allergic or seborrheic dermatitis and ...; having patient's satisfaction ; lack of other systemic acne accelerator diseases such as Cushing's syndrome, PCO, adrenal hyperplasia, acquired and innate immun deficiency, steroid acne and acneiform lesions and.... ; patients who are not used of oral or topical anti-acne medications, during the previous month, even include natural and UV light, herbal and traditional acne treatments.
Age
From 11 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Tabriz University of Medical Science and Health Services
Street address
Deputy of Tabriz University of Medical Sciences and Health Services, Golgasht Street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2010-10-23, 1389/08/01
Ethics committee reference number
6996/4/5

Health conditions studied

1

Description of health condition studied
Mild to modrate acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris

Primary outcomes

1

Description
Acne severity index
Timepoint
Every15 days
Method of measurement
History, physical examination, counting and statistical evaluation

Secondary outcomes

1

Description
Age
Timepoint
Every 15 days
Method of measurement
History

2

Description
Gender
Timepoint
Every 15 days
Method of measurement
History

3

Description
Comedon
Timepoint
Every 15 days
Method of measurement
Physical examination and counting

4

Description
Papule
Timepoint
Every 15 days
Method of measurement
Physical examination and counting

5

Description
Pustule
Timepoint
Every 15 days
Method of measurement
Physical examination and counting

6

Description
Total numbers of lesions
Timepoint
Every 15 days
Method of measurement
Physical examination and counting

7

Description
Patient's satisfaction
Timepoint
Every 15 days
Method of measurement
History

8

Description
Side efect of treatment
Timepoint
Every 15 days
Method of measurement
History and physical examination

Intervention groups

1

Description
Intervention group: combination of erythromycin 4 g and salicylic acid in 10 cc propylene glycol and alcohol 70 degrees to the volume of the overall 100 cc will apply to the face with cotton applicator twice aday for 3 months
Category
Treatment - Drugs

2

Description
Control group: combination of erythromycin 4 g in 10 cc propylene glycol and alcohol 70 degrees to the volume of the overall 100 cc will be apply to the face with cotton applicator twice aday for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Educational and Treatment Center ,Tabriz University of Medical Science and Health Services
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Farideh Golfroushan
Street address
Sina Educational and Treatment Center- Department of Dermatology
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz University of Medical Sciences and Health Services
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
Deputy of Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Farideh Golfroushan
Position
Dermatologist
Other areas of specialty/work
Street address
Sina Educational and Treatment Center, Tabriz University of Medical Science and Health Services
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
Dr_fgolfroushan@yahoo.com & golfroushanf@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Deputy of Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Farideh Golfroushan
Position
Dermatologist
Other areas of specialty/work
Street address
Deputy of Tabriz University of Medical Sciences and Health Services, Golgasht Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
Dr_fgolfroushan@yahoo.com golfroushanf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Deputy of Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Farideh Golfroushan
Position
Dermatologist
Other areas of specialty/work
Street address
Deputy of Tabriz University of Medical Sciences and Health Services, Golgasht Street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
Dr_fgolfroushan@yahoo.com golfroushanf@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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