The purpose of this study is to compare therapeutic effects of topical Isotretinoin %0.05 with Clindamycine %1 in the treatment of papulo pustular acne. We will include patients aged between 11 to 30 years and will exclude pregnant and lactating women and patients who have used anti acne drugs in recent month. We will prescribe topical Isotretinoin gel in 30 patients every night and topical Clindamycin in 30 other patients twice daily for 90 days. Each patient will be examined at the onset and every 30 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105032581N2
Registration date:2011-11-26, 1390/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-26, 1390/09/05
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Univercity of Medical Sciences
Expected recruitment start date
2011-08-10, 1390/05/19
Expected recruitment end date
2012-05-08, 1391/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of topical Isotretinoin %0.05 with Clindamycine %1 in the treatment of papulo pustular acne vulgaris
Public title
Comparison of therapeutic effects of topical Isotretinoin %0.05 and Clindamycine %1 in the treatment of acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with mild to moderate acne between 11 to 30 years old; patients who have at most 20 inflammatory lesion (papule, pustule) in one side of face and don't have more than 3 nodule or cyst in the same side; tendency to intend in study. Exclusion criteria: pregnant and lactating women; patients who have used topical anti acne drugs in the recent month; patients who have used oral anti acne drugs in past 2 months; having any other facial skin disease other than acne; having sever nodulocystic acne; consumption of acne inducing drugs such as lithium, oral steroid, vit B12, brom and iodide drugs; patients who have more than 20 inflammatory lesion (papule, pustule) in one side of face and have more than 3 nodule or cyst in the same side.
Age
From 11 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Univercity of Medical Sciences
Street address
Vice Chancellor forresearch, 3rd floor, centural office, Tabriz Univercity of Medical Sciences, Golgasht st.
City
Tabriz
Postal code
Approval date
2011-04-18, 1390/01/29
Ethics committee reference number
5/4/748
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
severity
Timepoint
every 30 days
Method of measurement
History and clinical examination
Secondary outcomes
1
Description
pustules
Timepoint
every 30 days
Method of measurement
clinical examination
2
Description
total acne lesions
Timepoint
every 30 days
Method of measurement
clinical examination
3
Description
index of acne severity
Timepoint
every 30 days
Method of measurement
clinical examination, statistical measurment
4
Description
patient satisfaction
Timepoint
every 30 days
Method of measurement
Questionnare
5
Description
comedones
Timepoint
every 30 days
Method of measurement
clinical examination
Intervention groups
1
Description
Group A: topical Isotretinon gel 0.05% every night on acne lesions for 3months
Category
Treatment - Drugs
2
Description
Group B: 1% Clindamycine solution twice daily on acne lesion for 3months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and treatment center of Sina
Full name of responsible person
Dr. Herizchi Hamide
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Meshkini Ali
Street address
Tabriz University of Medical Sciences, Gholghasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice chancellor for research of Tabriz Univercity of Medical Sciences
Full name of responsible person
Dr. Herizchi Hamide
Position
Skin Disease Specialist / assistant
Other areas of specialty/work
Street address
Educational and treatment center of Sina
City
Tabriz
Postal code
Phone
+98 41 1336 4160
Fax
Email
herizchih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)