The purpose of this study was to determine the effects of vitamin E on reduction of mucocutaneous side effects of Isotretinoin in the treatment of acne vulgaris. In this placebo-controlled trial, 80 patients visited in dermatology special clinic were randomly assigned into the intervention or control group to receive 0.5-1 mg/kg/day Isotretinoin as well as 800 IU/day vitamin E or placebo for 6 weeks. The mucocutaneous side effects were clinically evaluated at the end of weeks 1, 4, and 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905022085N4
Registration date:2010-07-24, 1389/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-24, 1389/05/02
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2004-09-22, 1383/07/01
Expected recruitment end date
2005-02-19, 1383/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral vitamin E in reducing mucocutaneous side effects of Isotretinoin
Public title
Oral vitamin E in reducing mucocutaneous side effects of Isotretinoin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from Acne vulgaris, indication of treatment with Isotretinoin
Exclusion criteria: age lesser than 15 years old, pregnancy, breast feeding
Age
From 15 years old to 39 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
1383-06-06, 765/01/-1017
Ethics committee reference number
1-6-83
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
mucocutaneous side effects of Isotretinoin
Timepoint
After 4 and 6 weeks
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Isotretinoin, 0.5-1 mg/kg/day, as well as 800 IU/day vitamin E for 6 weeks
Category
Treatment - Drugs
2
Description
Isotretinoin, 0.5-1 mg/kg/day, as well as placebo for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Diseases Clinic, Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Street address
Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Research deputy
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord Medical University Of Science
Full name of responsible person
Neda Parvin
Position
Lecturer
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
np285@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)