objective: In this study the effects of systemic isotretinoin will be evaluated on normal flora of the nose and throat.
design: This is a clinical trial study
setting and conduct: Before and three months after starting treatment, three nasal and oropharynx samples will be taken wit a sterile swab. Normal flora and potential pathogens bacteria differences before and 3 months after of treatment will be examined in a patient with acne vulgaris referring to BoAli Sina Hospital, Sari.
Participants including major eligibility: people over 13 years of age with moderate to severe acne.
intervention: Isotretinoin treatment will be done with a daily dose of 0.5 mg/kg for 3 months.
main outcomes: normal and pathogen microbial flora of nose and throat
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120427636N4
Registration date:2017-04-10, 1396/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Ghasem Rahmatpour Rokni
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3322 1755
Email address
gh.rahmatpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Science and Technology, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of systemic isotretinoin on the nasal and oropharyngeal microbial flora in patients with acne vulgaris
Public title
the effect of oral isotretinoin on the nasal and oral bacteria in patients with acne
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with moderate to severe acne candidates for systemic isotretinoin therapy.;consent to participate in the study
Exclusion criteria: Patients who are pregnant or lactating women;topical or systemic anti-acne drugs or antibiotics were used a month prior to or in conjunction with study.; Patients have been affected with infectious and respiratory diseases a month before o during the study.; Patients with chronic liver disease or peptic ulcer 5-consumers of drugs that cause acne include: vitamin B12, topical steroids or systemic anti-TB drugs, lithium, azathioprine, carbamazepine and phenytoin;patients with Hematologic disorders (according hematologic side effects of treatment)
Age
From 13 years old to 50 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Mazandaran University of Medical Sciences
Street address
Moallem square,Sari
City
Sari
Postal code
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
IR.MAZUMS.REC.94-1460
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
nose and throat microbial flora
Timepoint
before treatment intervention & 3 months after treatment intervention