Objectives: To comparison of the efficacy of low-dose and conventional dose of oral Isotretinoin in the treatment of moderate to severe acne vulgaris. Design: Randomized, single blind, clinical trial. Patients were blinded to the intervention group. Setting and Conduct: 60 patients that involved in moderate to severe acne vulgaris. They are placed in 2 groups. Per group has 30 patients. group 1 treated with 0.5 mg per kg daily of oral isotrtinoin for 6 months and group 2 treated with 0.25 mg per kg daily of oral isotrtinoin for 6 months. Outcome measures will be assessed by the use of global acne grading system at baseline and 6 and 12 months later. Major Inclusion and Exclusion criteria: Inclusion criteria: absence of hypersensitivity to retinoid; absence of pregnancy or plan of pregnancy; no history of hormonal abnormality exclusion criteria: impassible to follow up; use of other treatment Intervention: One group treated with low dose of oral isotretinoin and other group treated with traditional dose of oral isotretinoin. Main Outcome Measures: Improvement in skin lesions of acne vulgaris assessed by global acne grading system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061722780N1
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Nasrin Motamedi fard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 4422
Email address
nasrin_motamedi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences + Patients + Investigator
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of the efficacy of low-dose and conventional dose of oral Isotretinoin in the treatment of moderate to severe acne vulgaris.
Public title
Efficacy of oral low-dose Isotretinoin in the treatment of acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Absence of hypersensitivity to Retinoid; Absence of pregnancy or plan of pregnancy; no history of hormonal abnormality
exclusion criteria: impossible to follow up; use of another treatment
Age
From 15 years old to 70 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
Not used
Assignment
Parallel
Other design features
random allocation was by blocking method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2014-11-06, 1393/08/15
Ethics committee reference number
393894
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
Quantity of skin lesions of acne vulgaris
Timepoint
At first and six months after initiation of treatment and six months after cessation of treatment
Method of measurement
Computation of lesions and utilization of global acne grading system
Secondary outcomes
1
Description
Increase of liver enzymes and increase of serum lipid profile
Timepoint
At first and one and two and four and six months after initiation of treatment
Method of measurement
Transmission of blood sample to medical laboratory
Intervention groups
1
Description
Prescription of low dose of oral isotretinoin in intervention group
(0.25 mg/kg/day) six months
Category
Treatment - Drugs
2
Description
prescription of traditional dose of oral isotretinoin (0.5 mg/kg/day) six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AL Zahra Hospital and Sedigheh tahere center
Full name of responsible person
Dr Nasrin Motamedi Fard
Street address
Department of Dermatology, Al Zahra Hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Deputy of Research of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan.
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan 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
Isfahan University Of Medical Science
Full name of responsible person
Dr Nasrin Motamedi Fard
Position
Resident of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
8173955765
Phone
+98 31 3335 4422
Fax
+98 31 3663 3061
Email
motamedinasrin@ yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr. Fatemeh Mokhtari
Position
Professor Assistant
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan .
City
Isfahan
Postal code
8173955765
Phone
+98 31 3335 4422
Fax
+98 31 3663 3061
Email
f-mokhtari@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermatology, Al Zahra Hospital, Isfahan
Full name of responsible person
Dr Nasrin Motamedi Fard
Position
Resident of dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan .
City
Isfahan
Postal code
Phone
+98 31 3335 4422
Fax
+98 31 3628 9194
Email
nasrin_motamedi@ med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)