The aim of this study is to evaluate the effect of clinda soap on the treatment of acne vulgaris. The study includes patients with acne vulgaris referring to our dermatologists' office. Inclusion criteria: 1 - mild to moderate acne 2 – Age range of the patient between 15 to 35 years 3 - written consent of the patients. Exclusion criteria: 1 - Pregnancy and lactation 2-presense of any chronic diseases - 3 receiving antibiotics during the last month before study 4 - use of acnegenic drugs, vit B 12, litum, carbamazepine, phenytoin. 100 patients will be allocated into 2 groups based on blocked randomization. Both groups will receive the standard therapy of acne vulgaris and intervention group also will receive clinda soap for washing of the skin lesions 2 times /day in the morning and evening. Control group will use placebo soap for washing of the skin lesions 2 times / day in the morning and evening for 3 months. The patients will be followed by our dermatologist for the assessment of improvement and any side effect. Inflammatory and non inflammatory lesions, including comedon and papule will be counted and recorded by the same dermatologist before treatment and one mounth, 2 months and 3 months after treatment. Side effects of the soap including: scaling, dry skin, burning sensation and itching will be assessed, based on a 0 to 3 scale. 0=no side effect. 1=mild, 2=moderate and 3=severe.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009254808N1
Registration date:2011-01-16, 1389/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-16, 1389/10/26
Registrant information
Name
Mozhdeh Zarei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1278
Email address
mozh.zarei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Clinda soap on the acne vulgaris treatment
Public title
Clinda soap effects on acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - mild to moderate acne 2 – Age range of the patient between 15 to 35 years 3 - written consent of the patients. Exclusion criteria: 1 - Pregnancy and lactation 2-presense of any chronic diseases - 3 receiving antibiotics during the last month before study 4 - use of acnegenic drugs, vit B 12, litum, carbamazepine and phenytoin.
Age
From 15 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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
Kurdistan University of Medical Sciences
Street address
Pasdaran blvrd
City
Sanandaj
Postal code
66117713446
Approval date
2010-08-07, 1389/05/16
Ethics committee reference number
پ14پ46963
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
Improvement of Acne lesion
Timepoint
Monthly
Method of measurement
Assessment of the severity and count of lesions by dermatologist
Secondary outcomes
1
Description
Side effects (including erythema , scaling , dry skin and burning sensation or praritms)
Timepoint
every month
Method of measurement
Examination of the patients by dermatologists
Intervention groups
1
Description
Intervention group: ClInda soap will be used 2 times / day in the morning and night for 3 months.
Category
Treatment - Drugs
2
Description
Control group: placebo soap will be used 2 times /daly in the morning and night for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rad dermatology clinic
Full name of responsible person
Mozhdeh Zarei
Street address
University of Medical Sciences, Pasdaran blvrd
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Pasdaran blvrd
City
Sanandaj
Grant name
Grant code / Reference number
44000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Mozhdeh Zarei
Position
M.A
Other areas of specialty/work
Street address
University of Medical Sciences, Pasdaran blvrd
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1613 1278
Fax
+98 87 1666 4654
Email
MOZH.ZAREI@YAHOO.COM , MOZH.ZAREI@MUK.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
DR. Farokh Rad
Position
Dermatologist
Other areas of specialty/work
Street address
University of Medical Sciences, Pasdaran blvrd
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1613 1278
Fax
+98 87 1666 4654
Email
mozh.zarei@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mozhdeh Zarei
Position
M.A
Other areas of specialty/work
Street address
University of Medical Sciences, Pasdaran blvrd
City
Sanandaj
Postal code
Phone
+98 87 1613 1278
Fax
+98 87 1666 4654
Email
MOZH.ZAREI@YAHOO.COM , MOZH.ZAREI@MUK.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)