Introduction: The aim of the present study was the evaluation of serum level of lipids and liver enzymes markers, folic acid, homocysteine and hematological markers in patients with acne vulgaris undergoing isotertinoin treatment.
Methods: Forty-four patients, with severe acne or moderate acne who were resistant to conventional treatment were supplemented with 0.5 mg/kg/day of oral isotertinoin for 120 days. We would excloud diabetic patients, coronary heart disease, metabolic disorders and etc. The serum levels of cholesterol, triglyceride, liver enzymes markers, folic acid, homocysteine, urea and creatinine measured at the baseline and at the end of the treatment period. Then white blood cell (WBC), red blood cell (RBC) and platelets were counted; also the level of hemoglobin and hematocrite were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012103011316N1
Registration date:2013-01-08, 1391/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Hassan Ahmadvand
Name of organization / entity
Department of Biochemistry
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0133
Email address
ahmadvand.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2012-10-31, 1391/08/10
Expected recruitment end date
2013-02-28, 1391/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral isotertinoin on folic acid, homocysteine and biochemical and hematological markers in acne vulgaris patients
Public title
Effects of oral isotertinoin on folic acid, homocysteine and biochemical and hematological markers in acne vulgaris patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with acne volgaris on
general diet.
Exclusion Criteria: patients use others drugs; diabete mellitus; coronary heart disease; metabolic Disease and other serious diseases.
Age
From 17 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences-research center
Street address
1Department of Clinical Biochemistry, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran
City
Khorramabad
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
1275
Health conditions studied
1
Description of health condition studied
acne vulgaris
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Folic acid
Timepoint
aat the baseline and end of the treatment period (120 day)
Method of measurement
by immunoassay method using commercial randox kits
2
Description
Homosysteine
Timepoint
at the baseline and end of the treatment period (120 day)
Method of measurement
by immunoassay method using commercial Randox kits
Secondary outcomes
1
Description
Lipid profile
Timepoint
at the baseline and end of the treatment period (120 day)
Method of measurement
by autoanalyzer using commercial pars azemon kits
2
Description
Gama glutamiltransferase
Timepoint
at the baseline and end of the treatment period (120 day)
Method of measurement
by autoanalyzer using commercial pars azemon kits
3
Description
Alanin trans aminase
Timepoint
at the baseline and end of the treatment period (120 day)
Method of measurement
by autoanalyzer using commercial pars azemon kits
4
Description
Aspartat trans aminase
Timepoint
at the baseline and end of the treatment period (120 day)
Method of measurement
by autoanalyzer using commercial pars azemon kits
Intervention groups
1
Description
Intervention
Treatment of patient would supplement with 0.5 mg/kg/day of oral isotertinoin for 120 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospial of Shohadaie Ashaier
Full name of responsible person
Street address
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Hassan Kayedi
Street address
School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Hassan Ahmadvand
Position
associated professor
Other areas of specialty/work
Street address
School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran
City
Khorramabad
Postal code
Phone
+98 66 1620 0133
Fax
Email
hassan_a46@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine, Lorestan University of Medical Sciences
Full name of responsible person
Hassan Ahmadvand
Position
asociated professor
Other areas of specialty/work
Street address
School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran
City
Khorramabad
Postal code
Phone
+98 66 1620 0133
Fax
Email
hassan_a46@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Hassan Ahmadvand
Position
PhD
Other areas of specialty/work
Street address
Khoramabad –Kamalvand- Lorestan University of Medical Sciences- Faculty of Medicine- Department of Biochemistry
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0133
Fax
+98 66 1620 0133
Email
hassan_a46@yahoo.com
Web page address
http://www.lums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)