Aim of the study is evaluation the effect of Isotretinoin on androgen level in women with Acne Vulgaris.
Inclusion criteria: 18-30 years old women with moderate to severe acne vulgaris. Exclusion criteria: pregnancy; hypersensitivity to parabens; poly cystic ovarian disease; recent history of mood or depressive disorders; thyroid disease; pituitary disease and use of Finasteride; retinoids or hormonal contraception within three months of enrollment.
Sample size: 36 women who involved acne vulgaris.
Intervention: 20 mg isotretinoine (Roaccutane) daily for a period of three months. Outcome study: comparison between androgenic hormones levels dehydroepiandrosterone (DHEA), 17-hydroxyprogestrone, testosterone, free testosterone, dihydrotestosterone (DHT), luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052725407N2
Registration date:2017-06-07, 1396/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Amir Feily
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 715234665
Email address
dr.feily@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2014-02-17, 1392/11/28
Expected recruitment end date
2015-11-18, 1394/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of isotretinoin on androgen hormone level in women with acne vulgaris
Public title
The effect of isotretinoin in the treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-30 years old women with moderate to severe acne vulgaris.
Exclusion criteria: pregnancy; hypersensitivity to parabens; poly cystic ovarian disease; recent history of mood or depressive disorders; thyroid disease; pituitary disease and use of Finasteride; retinoids or hormonal contraception within three months of enrollment.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Postal code
Approval date
2014-02-26, 1392/12/07
Ethics committee reference number
IR.JUMS.REC.1392.063
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70.0
ICD-10 code description
Acne Vulgaris
Primary outcomes
1
Description
Dihydrotestosterone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
2
Description
17-hydroxyprogestrone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
3
Description
Testosterone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
4
Description
Dehydroepiandrosterone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
5
Description
Free testosterone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
6
Description
Luteinizing hormone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
7
Description
Follicle stimulating hormone
Timepoint
Before and after the intervention
Method of measurement
ng/ml
8
Description
Prolactin
Timepoint
Before and after the intervention
Method of measurement
ng/ml
Secondary outcomes
empty
Intervention groups
1
Description
Orally tablet of 20 mg isotretinoine (Roaccutane)daily for a period of three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hair and Skin clinic
Full name of responsible person
Dr. Amir Feily
Street address
Moalem Blvd.
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Kavous Solhju, Vice chancellor for research
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Feily
Position
Dermatologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Postal code
Phone
+98 71 5444 0821
Fax
Email
edu@jums.ac.ir
Web page address
www.jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Feily
Position
Dermatologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Postal code
Phone
+98 71 5444 0821
Fax
Email
edu@jums.ac.ir
Web page address
www.jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Feily
Position
Dermatologist
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari street
City
Jahrom
Postal code
Phone
+98 71 5444 0821
Fax
Email
edu@jums.ac.ir
Web page address
www.Jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)