Protocol summary

Summary
the purpose of this study is therapeutic effects of ozonated olive oil on acne vulgaris.this is a single blind(for patients ), non-randomised clinical trial with interventionale and placebo groups. inclusion criteria:age between 10 to 30. not use antibiotic.corton and anti inflammatory drugs from one month before begining of study. exclusion criteria:hypersensitivity , pregnancy, lactation. 25 patients have been considered as volume sample.every person used placebo on the part of his/her lesions for one month.after 10 days wash outs we gave him/her ozonated olive oil for using on his/her whole lesions for one month.the outcome is expressed as a percentage of reduced inflammatory and non-inflammatory hesions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011220646N1
Registration date: 2016-01-22, 1394/11/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Maryam Akbari
Name of organization / entity
Pharmacy College of Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51388223271
Email address
akbarim891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmacy College of Mashhad University of Medical Science
Expected recruitment start date
2015-11-26, 1394/09/05
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
formulation and study of ozonated olive oil' s effect on treatment of acne vulgaris
Public title
ozonated olive oil and acne
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:age between 10 to 30 not use antibiotic.corticosteroids and anti inflammatory drugs from one month before beginning of study. exclusion criteria:hypersensitivity .pregnancy.lactation
Age
From 10 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commite of Mashhad University of Medical Science
Street address
Ghoreishi building,Daneshgah street,Mashhad
City
Mashhad
Postal code
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR.MUMS.REC.1394.579

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
number of inflammatory and non inflammatory lesion
Timepoint
before intervetion ,after intervetion
Method of measurement
counting the lesions

Secondary outcomes

empty

Intervention groups

1

Description
using placebo and ozonated olive oil for lesion on one person
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pharmacy College of Mashhad University of Medical Science/ Qaem Hospital
Full name of responsible person
Dr Pouran Layegh
Street address
Qaem hospital, Ahmad Abad street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Pharmacy College of Mashhad University of Medical Science
Street address
Pharmacy College of Mashhad University of Medical Science,Azadi squre, Mashhad
City
Mashhad
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, Mashhad 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
Pharmacy College of Mashhad University of Medical Science
Full name of responsible person
Dr Omid Rajabi
Position
Lectureship/Phd
Other areas of specialty/work
Street address
Pharmacy College of Mashhad University of Medical Science, Azdi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
rajabio@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pharmacy College of Mashhad University of Medical Science
Full name of responsible person
Dr Omid Rajabi
Position
Lectureship/Phd
Other areas of specialty/work
Street address
Pharmacy College of Mashhad University of Medical Science, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
rajabio@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pharmacy College of Mashhad University of Medical Science
Full name of responsible person
Maryam Akbari
Position
Student
Other areas of specialty/work
Street address
Pharmacy College of Mashhad University of Medical Science, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
akbarim891@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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